Dissolution Methods

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Dissolution Methods
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Recommended
Sampling Times Date
Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (mL) (minutes) Updated
Abacavir Sulfate Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15, and 30 03/22/2006
Abacavir Sulfate/Dolutegravir Tablet II (Paddle) 85 0.01 M Phosphate Buffer with 900 Abacavir and 05/28/2015
Sodium/Lamivudine 0.5% sodium dodecyl sulfate lamivudine: 10, 15,
(SDS), pH 6.8 20, 30 and 45;
Dolutegravir: 5,15,
25, 35 and 45.
Abacavir Sulfate/Lamivudine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, and 45 01/03/2007
Abacavir Sulfate/Lamivudine Tablet II (Paddle) 75 0.1 N HCl Acid Stage: 900 mL; 5, 10, 15, 30 and 45 01/03/2007
/Zidovudine Buffer Stage: 1000
mL
Abemaciclib Tablet II (Paddle) 75 0.01 N HCl 900 5, 10, 15, 20 and 30 11/16/2017
Abiraterone Acetate Tablet II (Paddle) 50 0.25% SLS in 56.5 mM 900 10, 20, 30, 45 and 02/28/2013
phosphate buffer, pH 4.5 60
Acalabrutinib Capsule II (Paddle) with 50 0.1 M HCl 900 5, 10, 15, 20, 30 02/08/2018
sinker and 45
Acamprosate Calcium Tablet (Delayed I (Basket) 180 Acid Stage: 0.1 N HCl Buffer Media 1: 750 mL pH 120 (Acid) 30, 60, 12/20/2005
Release) Stage: "Citrate-sodium 1.1±0.1; Media 2: 90, 120, and 180
hydroxide" buffer pH 6.8 (150 950 mL pH 6.0±0.1; (buffer)
ml of 2N NaOH, 21.014 gm of Media 3: 1000 mL
citric acid and ultra-pure water pH 7.5±0.1
to 1000 ml) (Method B)
Acarbose Tablet II (Paddle) 75 Water (deaerated) 900 10, 15, 20, 30 and 03/22/2006
45
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Dissolution Methods https://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_getallData.cfm
Recommended
Sampling Times Date
Acetaminophen Suppository II (Paddle) 50 Phosphate buffer, pH 5 900 15, 30, 45, 60 and 08/17/2006
90
Acetaminophen Tablet (Extended Refer to USP 03/03/2011

Release)
Acetaminophen/Aspirin/Caffeine Tablet Refer to USP 06/25/2015
Acetaminophen/Butalbital Tablet II (Paddle) 50 Water (deaerated) 900 15, 30, 45, 60 and 01/03/2007
90
Acetaminophen/Butalbital/Caffeine Tablet Refer to USP 01/14/2008
Acetaminophen/Butalbital/Caffeine Capsule II (Paddle) 50 Water (deaerated) 1000 10, 20, 30, 45 and 05/15/2014
/Codeine Phosphate 60
Acetaminophen/Caffeine Tablet II (Paddle) 50 Water 900 10, 15, 30, 45 and 07/25/2007
/Dihydrocodeine Bitartrate 60
Acetaminophen/Caffeine Capsule I (Basket) 100 Water 900 10, 20, 30, 45 and 01/03/2007
/Dihydrocodeine Bitartrate 60
Acetaminophen/Hydrocodone Tablet Refer to USP (provide 08/15/2013

Bitartrate individual unit data).
Acetaminophen/Oxycodone Tablet Refer to USP 01/14/2008
Acetaminophen/Oxycodone HCl Tablet (Extended II (Paddle) with 100 0.1 N HCl 900 0.25, 0.5, 1, 2, 4, 6 11/19/2015
Release) sinker and 8 hours
Acetaminophen/Pentazocine HCl Tablet I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45 and 01/12/2004
60
Acetaminophen/Propoxyphene HCl Tablet Refer to USP 01/15/2010
Acetaminophen/Propoxyphene Tablet Refer to USP 01/15/2010

Napsylate
Acetaminophen/Tramadol HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Acetazolamide Capsule (Extended II (Paddle) 75 Acetate Buffer, pH 4.5 with 900 1, 2, 5, 7, 9, 12 and 01/15/2010
Release) 2.2% Tween 20 14 hours
Acetazolamide Tablet Refer to USP 07/21/2011
Acetazolomide Tablet Refer to USP 07/14/2008
Acetylcysteine Tablet (Effervescent) Develop a dissolution method 07/28/2016
Acitretin Capsule Refer to USP 09/22/2011
Acrivastine/Pseudoephedrine HCl Capsule II (Paddle) 50 0.01 N HCl 900 5, 10, 15 and 30 01/12/2004
Acyclovir Suspension II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 02/20/2004
60
Acyclovir Capsule Refer to USP 01/05/2012
Acyclovir Tablet (Buccal) I (Basket) 60 Phosphate Buffer, pH 6.0 1000 1, 2, 3, 5, 7, 9 and 08/27/2015
12 hours
Acyclovir Tablet Refer to USP 06/18/2007
Adefovir Dipivoxil Tablet II (Paddle) 50 0.01 N HCl 600 10, 20, 30, 45 and 04/10/2008
60
Afatinib Dimaleate Tablet II (Paddle) 75 McIlvaine Buffer pH 4.0 900 5, 10, 15, 20 and 30 05/28/2015
Albendazole Tablet (Chewable) II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 03/17/2016
45
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Recommended
Sampling Times Date
Albendazole Tablet Refer to USP 08/15/2013
Albuterol Sulfate Tablet (Extended II (Paddle) 50 0.1 N HCl 900 1, 2, 4, 6, 9 and 12 04/09/2007
Release) hours
Albuterol Sulfate Tablet Refer to USP 09/03/2008
Alectinib HCl Capsule II (Paddle) with 100 pH 1.2, Simulated Gastric Fluid 900 10, 20, 30, 45, 60, 03/17/2016
sinker without pepsin, containing 4 % 75 and 90
Triton X-100
[polyoxyethylene[10]octylphenyl
ether]
Alendronate Sodium Tablet Refer to USP 01/14/2008
Alendronate Tablet II (Paddle) For Alendronate: 50; For Alendronate: Deaerated For Alendronate: 10, 15, 20, 30 and 11/25/2008
Sodium/Cholecalciferol For Cholecalciferol: Water; For Cholecalciferol: 900; For 45
75 0.3% SDS in USP Water Cholecalciferol: 500
Alfuzosin HCl Tablet (Extended II (Paddle) 100 0.01 N HCl 900 1, 2, 12, 20 hours 06/18/2007
Release)
Aliskiren Hemifumarate Capsule (pellet) I (Basket) 100 0.01 M HCl (degas) 500 5, 10, 15, 20, 30 02/08/2018
and 45
Aliskiren Hemifumarate Tablet I (Basket) 100 0.01 N HCl 500 10, 20, 30 and 45 09/03/2008
Aliskiren Hemifumarate/Amlodipine Tablet I (Basket) 100 0.01 N HCl, pH 2.0 500 10, 15, 20, 30 and 06/07/2012
Besylate 45
Aliskiren Hemifumarate/Amlodipine Tablet I (Basket) 100 0.01 N HCl 900 10, 15, 20, 30 and 06/07/2012
Besylate/Hydrochlorothiazide 45
Aliskiren Tablet I (Basket) 100 0.1 N HCl 900 10, 15, 20, 30 and 10/08/2009
Hemifumarate/Hydrochlorothiazide 45
Aliskiren Hemifumarate/Valsartan Tablet I (Basket) 100 Phosphate Buffer, pH 6.8 1000 5, 10, 15, 20, 30 12/23/2010
and 45
Allopurinol Tablet Refer to USP 07/25/2007
Almotriptan Malate Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, and 30 01/20/2006
Alogliptin Benzoate Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 20 and 30 02/14/2014
Alogliptin Benzoate/ Metformin HCl Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 20 and 30 11/19/2015
Alosetron HCl Tablet II (Paddle) 50 (for 1 mg) & 75 Water (deaerated) 500 10, 20, 30 and 45 01/26/2006
(for 0.5 mg)
Alprazolam Tablet (Extended I (Basket) 100 1% Phosphate Buffer, pH 6.0 500 1, 4, 8, 12 and 16 02/08/2007
Release) hours
Alprazolam Tablet (Orally II (Paddle) 50 70 mM Potassium Phosphate 500 2, 5, 10, 15 and 20 10/06/2008
Disintegrating) Buffer, pH 6.0
Alprazolam Tablet Refer to USP 06/18/2007
Altretamine Capsule Refer to USP 01/29/2010
Alvimopan Capsule II (Paddle 50 0.1 N HCl 900 5, 10, 15, 20, 30 10/21/2010
and 45
Amantadine HCl Capsule Refer to USP 12/23/2010
Amantadine HCl Tablet II (Paddle) 50 Water (deaerated) 500 10, 20, 30, 45 and 01/12/2004
60
Ambrisentan Tablet II (Paddle) 75 0.05 M Acetate Buffer, pH 5.0 900 5, 10, 15, 30, and 05/20/2009
45
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Recommended
Sampling Times Date
Amiloride HCl Tablet Refer to USP 06/07/2012
Amiloride HCl/Hydrochlorothiazide Tablet Refer to USP 06/07/2012
Aminocaproic Acid Tablet Refer to USP 08/27/2015
Aminosalicylic Granule (Delayed II (Paddle) 100 Acid Stage: 0.1 N HCl; Buffer 1000 Acid Stage: 2 hours; 07/14/2008
Release) Stage 2: pH 7.5 Phosphate Buffer Stage: 1, 2, 3
Buffer and 4 hours
Amiodarone HCl (Test 1) Tablet II (Paddle) 100 1% SLS in water 1000 10, 20, 30, 45, 60 01/12/2004
and 90
Amiodarone HCl (Test 2) Tablet I (Basket) 50 Acetate Buffer, pH 4.0, with 1% 900 10, 20, 30, 45, 60 01/12/2004
Tween 80 and 90
Amitriptyline HCl Tablet Refer to USP 01/14/2008
Amlodipine Besylate Tablet II (Paddle) 75 0.01 N HCl 500 10, 20, 30, 45 and 01/14/2004
60
Amlodipine Besylate Tablet (Orally II (Paddle) 50 0.01 N HCl 500 5, 10, 15 and 20 10/06/2008
Disintegrating)
Amlodipine Besylate/Atorvastatin Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8 900 5, 10, 15 and 30 04/02/2009
Calcium
Amlodipine Besylate/Benazepril Capsule I (Basket) 100 0.01 N HCl 500 10, 20 , 30, 45, and 06/20/2007
HCl 60
Amlodipine Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 07/21/2011
Besylate/Hydrochlorothiazide and 45
/Olmesartan Medoxomil
Amlodipine Tablet Refer to USP 07/28/2016

Besylate/Hydrochlorothiazide
/Valsartan
Amlodipine Besylate/Olmesartan Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900 10, 20, 30 and 45 08/11/2008
Medoxomil
Amlodipine besylate/Perindopril Tablet II (Teflon coated 75 0.01 N HCL 1000 5, 10, 15, 20 and 30 03/17/2016
Arginine paddle)
Amlodipine Besylate/Telmisartan Tablet II (Paddle) 75 Telmisartan: Phosphate Buffer, Telmisartan: 900; Telmisartan: 10, 15, 08/05/2010
pH 7.5; Amlodipine: 0.01N HCl, Amlodipine: 500 20, 30 and 45;
pH 2 Amlodipine: 10, 15,
20, 30 and 45
Amlodipine Besylate/Valsartan Tablet Refer to USP 07/28/2016
Amoxicillin Tablet (Extended II (Paddle) 100 3 Stage dissolution: 50 mM 900 0.25, 0.5, 1, 2, 2.25, 10/21/2010
Release) potassium phosphate 2.5, 3, 4, 4.25, 4.5,
monobasic buffer at pH 4.0 (0-2 5 and 6 hours
hours), 6.0 (2-4 hours) and 6.8
( 4 hours and beyond)
Amoxicillin For Oral Suspension II (Paddle) 50 Water (degassed) 900 5, 10, 15, 20, 30 06/06/2013
and 45
Amoxicillin Capsule Refer to USP 01/31/2013
Amoxicillin Tablet Refer to USP 01/31/2013
Amoxicillin/Clarithromycin Capsule/Tablet Refer to USP for monographs 02/28/2013

/Lansoprazole /Capsule (Copackage) of Amoxicillin Capsules,
Clarithromycin Tablets and
Lansoprazole Delayed-Release
Capsules
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Recommended
Sampling Times Date
Amoxicillin/Clarithromycin Capsule/Tablet Refer to USP for monographs 02/28/2013

/Omeprazole /Capsule (Copackage) of Amoxicillin Capsules,
Clarithromycin Tablets and
Omeprazole Delayed-Release
Capsules
Amoxicillin/Clavulanate Potassium Tablet Refer to USP As appropriate 0, 0.5, 1, 2, 3, 4 and 10/04/2012

5 hours
Amoxicillin/Clavulanate Potassium Suspension II (Paddle) 75 Water (deaerated) 900 5, 10, 15 and 30 01/14/2004
Amoxicillin/Clavulanate Potassium Tablet (Chewable) Refer to USP 01/14/2008
Amphetamine Tablet (Extended II (Paddle 75 Acid Stage: 0.1 N HCl; Buffer Acid Stage: 900 mL; Acid Stage: 10, 15, 07/28/2016
Release, Orally Stage: Phosphate Buffer, pH Buffer Stage: 1000 30, 45, 60, 90, 120;
Disintegrating) 6.8 mL Buffer Stage: 5, 10,
15, 30 and 45
Amphetamine Suspension (Extended Develop a dissolution method 12/22/2016

Release)
Amphetamine Capsule (Extended II (Paddle) 50 Dilute HCl, pH 1.1 for first 2 hrs, 0-2 hrs: 750 mL. 0.5, 1, 2, 3, and 4 07/25/2007
Aspartate/Amphetamine Release) then add 200 mL of 200 mM After 2 hrs: 950 mL hours
Sulfate/Dextroamphetamine Phosphate Buffer and adjust to
Saccharate/Dextroamphetamine pH 6.0 for the remainder
Sulfate
Amphetamine Tablet I (Basket) 100 Deionized Water 500 10, 20, 30 and 45 11/25/2008
Aspartate/Amphetamine
Sulfate/Dextroamphetamine
Saccharate/Dextroamphetamine
Sulfate
Amphetamine Capsule (Extended II (Paddle) 50 Media 1: pH 1.1±0.1, Dilute HCl Media 1: 750 mL; 0.5, 1, 2, 3, 4, 6, 8, 11/16/2017
Aspartate/Amphetamine Release) 2 hours; Media 2: pH 6.0±0.1, Media 2: 950 mL; 10 and 12 hours
Sulfate/Dextroamphetamine Phosphate Buffer 3rd hour, Media 3: 1000 mL
Saccharate/Dextroamphetamine Media 3: pH 7.5±0.1,
Sulfate [12.5, 25, 37.5, 50 mg] Phosphate Buffer for the
remainder
Amphetamine ER Capsule II (Paddle) 50 750 ml of dilute HCl, pH 1.1 for 750 ml of dilute HCl, 1, 2, 3, 4, and 6 08/17/2006
the first 2 hours, then add 200 200 ml of phosphate hours
ml of 200 mM phosphate buffer, buffer
and adjust to pH 6 (w/ HCl or
NaOH) for the remainder
Amphotericin B Injectable (Liposomal) Develop a method to 07/28/2016

characterize in vitro release
Ampicillin/Ampicillin Trihydrate for Oral Suspension II (Paddle) 25 Water (deaerated) 900 5, 10, 15, 20 01/03/2007
Amprenavir Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 30, and 45 02/19/2008
Anagrelide HCl Capsule I (Basket) 100 0.1 N HCl 900 5, 10, 15, 30 and 45 01/14/2004
Anastrozole Tablet II (Paddle) 50 Water 900 5, 10, 15, and 30 01/03/2007

and 45
Apixaban Tablet II (Paddle) 75 0.05 M Sodium Phosphate 900 5, 10, 20, 30 and 45 05/09/2013
Buffer with 0.05% SLS, pH 6.8
Apremilast Tablet II (Paddle) 60 0.15% SLS in 25 mM Sodium 900 10, 15, 20, 30, and 05/18/2017
Phosphate Buffer, pH 6.8 45
Aprepitant For Oral Suspension II (Paddle) 50 Water (with 1.2% Tween 80) 900 5, 10, 15 and 20 03/17/2016
Aprepitant Capsule II (Paddle) 100 2.2% sodium dodecyl sulfate in 900 10, 15, 20, 30 and 01/20/2006
distilled water 45
Aripiprazole Tablet Refer to USP 06/30/2016
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Recommended
Sampling Times Date
Aripiprazole Tablet (Orally II (Paddle) 75 Acetate Buffer, pH 4.0 1000 10, 20, 30 and 45 08/11/2008
Disintegrating)
Aripiprazole For Intramuscular II (Paddle) 50 0.25% Sodium Dodecyl Sulfate 900 10, 15, 30, 60, 120, 06/25/2015
Suspension (Extended (SDS) Solution 180, 240, 300, 360,
Release) 420 and 480
Armodafinil Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/14/2008
Asenapine Maleate Tablet (Sublingual) II (Paddle) 50 Acetate Buffer, pH 4.5 500 1, 2, 3, 4 and 5 05/09/2013
Aspirin Capsule (Extended II (Paddle) with 100 0.05M Potassium Phosphate 900 1, 2, 3, 6, 9, 12, 16, 10/20/2016
Release) sinker Buffer (pH 7.4) with trypsin 22 and 30 hours
(.001%w/v) and sodium azide
(.025% w/v)
Aspirin Capsule Refer to USP 05/28/2015
Aspirin/ Omeprazole Tablet (Delayed I (Basket) 100 Acid Stage: 0.1 N HCl Acid Stage: 900; Acid Stage:120; 12/22/2016
Release) (degassed); Buffer Stage: Buffer Stage: 900 Buffer Stage:10, 20,
Phosphate Buffer, pH 6.8 30, 45, 60 and 75
(degassed)
Aspirin/Butalbital/Caffeine Capsule Refer to USP 06/24/2010
Aspirin/Butalbital/Caffeine Tablet Refer to USP 06/24/2010
Aspirin/Butalbital/Caffeine/Codeine Capsule Refer to USP 08/27/2009

Phosphate
Aspirin/Caffeine/Orphenadrine Tablet I (Basket) 75 Water (deaerated) 900 10, 20, 30, 45 and 01/15/2004
Citrate 60
Aspirin/Dipyridamole Capsule I (Basket) 100 0.01 N HCl for first hour, 0.1 M 0-1 hrs: 900 mL. Acid: 10, 20, 30, 45 10/09/2007
Phosphate Buffer, pH 5.5, 900 mL thereafter and 60 min;
thereafter Buffer:1, 2, 5, and 7
hours
Aspirin/Hydrocodone Bitartrate Tablet II (Paddle) 75 Acetate Buffer, pH 4.5 900 10, 20, 30, 45, 60 01/15/2004
and 90
Aspirin/Meprobamate Tablet I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45, 60 01/15/2004
and 90
Aspirin/Methocarbamol Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45, 60 01/15/2004
and 90
Aspirin/Oxycodone HCl Tablet Refer to USP 01/15/2010
Atazanavir Sulfate Capsule II (Paddle) 50 0.025 N HCl 1000 10, 20, 30 and 45 01/20/2006
Atazanavir Sulfate/ Cobicistat Tablet II (Paddle) 75 0.05 M Citrate Buffer (pH 2.8) 1000 Atazanavir: 10, 15, 12/24/2015
20, 30 and 45;
Cobicistat: 5, 10, 15,
20 and 30
Atenolol Tablet Refer to USP 02/14/2014
Atenolol/Chlorthalidone Tablet Refer to USP 02/14/2014
Atomoxetine HCl Capsule II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 12/20/2005
Atorvastatin Calcium Tablet II (Paddle) 75 0.05 M Phosphate buffer, pH 900 5, 10, 15 and 30 01/15/2004
6.8
Atorvastatin Calcium/Ezetimibe Tablet II (Paddle), with 75 Phosphate buffer, pH 6.8 with 900 5, 10, 15, 20, 30 05/15/2014
option to use a 0.2% w/v Tween 80 and 45
sinker for 20/10
mg strength
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Recommended
Sampling Times Date
Atovaquone Tablet II (Paddle) 50 40% isopropanol buffered to pH 900 10, 20, 30, 45, 60 06/18/2007
8.0 with potassium dihydrogen and 90
phosphate
Atovaquone Oral Suspension Develop a dissolution method 07/21/2009
Atovaquone/Proguanil HCl Tablet II (Paddle) with 50 40% isopropranol buffered to 900 15, 30, 45 and 60 08/17/2006
PEAK vessels pH 8.0 with potassium
dihydrogen phosphate
Atropine Sulfate/ Diphenoxylate Tablet Develop dissolution method(s) 12/22/2016

HCl to characterize the dissolution
of both components
Auranofin Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30, and 45 01/15/2004
Avanafil Tablet II (Paddle) 50 Simulated gastric fluid without 900 5, 10, 15, 20 and 30 04/02/2015
pepsin.
Axitinib Tablet II (Paddle) 75 0.01 N HCl 900 5, 15, 30, 45 and 60 08/14/2014
Azacitidine Injectable Suspension Develop a dissolution method 09/03/2008
Azathioprine Tablet Refer to USP 04/08/2010
Azilsartan Kamedoxomil Tablet II (Paddle) 50 Phosphate Buffer, pH 7.8 900 5, 10, 15, 20, 30 05/09/2013
(deaerated) and 45
Azilsartan Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 05/09/2013
Kamedoxomil/Chlorthalidone containing 1.0% Tween 80, and 45
Azithromycin Oral Suspension II (Paddle) 50 Phosphate buffer, pH 6.0 900 10, 20, 30, and 45 08/17/2006
Azithromycin Suspension (Extended II (Paddle) 50 Phosphate Buffer, pH 6.0 900 15, 30, 45, 60, 120 04/15/2008
Release) and 180
Azithromycin Tablet Refer to USP 12/22/2016
Azithromycin Capsule Refer to USP 12/22/2016
Baclofen Tablet Refer to USP 12/15/2009
Baclofen Tablet (Orally II (Paddle) 25 50 mM Acetate Buffer, pH 4.5 500 mL (10 mg) or 5, 10, 15 and 30 07/14/2008
Disintegrating) 1000 mL (20mg)
Balsalazide Disodium Tablet II (Paddle) 100 Water (degassed) 1000 10, 20, 30, 45, 60, 07/31/2013
75, 90 and 120
Balsalazide Disodium Capsule II (Paddle) with 50 pH 6.8 buffer 900 10, 20, 30, and 45 01/26/2006
sinker
Bedaquiline Fumarate Tablet I (Basket) 150 0.01 N HCl 900 10, 15, 20, 30 and 06/06/2013
45
Benazepril HCl Tablet II (Paddle) 50 Water (deaerated) 500 10, 20, 30 and 45 01/16/2004
Benazepril HCl/Hydrochlorothiazide Tablet I (Basket) 100 0.1 N HCl 500 10, 20, 30 and 45 01/16/2004
Bendroflumethiazide/Nadolol Tablet Refer to USP 07/25/2007
Benzonatate Capsule Refer to USP 12/24/2015
Benzphetamine HCl Tablet II (Paddle) 50 Water 900 10, 20 , 30, and 45 06/20/2007
Bepridil HCl Tablet I (Basket) 100 0.1 N HCl 900 10, 20, 30, 45 and 01/16/2004
60
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Recommended
Sampling Times Date
Betamethasone Injectable Suspension IV (Flow through Flow @ 8 mL/min 0.05% SLS, pH 3.0 or Develop 5, 10, 15, 30, 45, 04/08/2010
Acetate/Betamethasone Sodium cell) an in vitro release method 60, 90, 120, 180,
Phosphate using USP IV (Flow-Through 240, 300, and 360
Cell), and, if applicable,
Apparatus II (Paddle) or any
other appropriate method, for
comparative evaluation by the
Agency
Bethanechol Chloride Tablet Refer to USP 10/06/2008
Betrixaban Capsule II (Paddle) with 75 0.01 N HCl, (with addition of 900 5, 10, 15, 20 and 30 11/16/2017
sinker pepsin if gelatin crosslinking is
observed)
Bexarotene Capsule II (Paddle) 50 Tier 1 Medium: 0.5% HDTMA in 900 15, 30, 45 and 60 08/17/2006
0.05 M phosphate buffer, pH
7.5 Tier 2 Medium: 0.5%
HDTMA in 0.05 M phosphate
buffer, pH 7.5 with 0.05 g/L
pancreatin enzyme
Bicalutamide Tablet II (Paddle) 50 1% SLS in water 1000 10, 20, 30, 45 and 12/15/2005
60
Bisacodyl/Polyethylene glycol Tablet (Delayed II (Paddle) 100 Acid stage: 0.1 N HCl: Buffer Acid stage: 900 mL; Acid stage: 60; 03/02/2017
3350/ Potassium Chloride/Sodium Release), For Solution, stage: 0.05 M Phosphate Buffer stage: 900 Buffer stage: 10, 20,
Bicarbonate/ Sodium Chloride buffer, pH 6.8, with 0.15% mL 30, 45 and 60
sodium lauryl sulfate (SLS)
[only for Bisacodyl Tablets]
Bismuth Subcitrate Capsule II (Paddle) 75 Tetracycline and Metronidazole: 900 5, 15, 20, 30 and 45 10/06/2008
Potassium/Metronidazole 0.1 N HCl; Bismuth Subcitrate
/Tetracycline HCl Potassium: Water
Bisoprolol Fumarate Tablet Refer to USP 06/18/2007
Bisoprolol Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 20, 30 and 45 01/20/2004
Fumarate/Hydrochlorothiazide
Boceprevir Capsule II (Paddle) with 50 50 mM phosphate buffer, pH 900 10, 20, 30, 45, 60 01/31/2013
sinker 6.8 with 0.1% sodium dodecyl and 75
sulfate
Bosentan Tablet (For II (Paddle) 75 0.1 N HCl with 0.5% sodium 900 5, 10, 15, 20 and 30 11/16/2017
Suspension) dodecyl sulfate (SDS), pH 1.1
Bosentan Tablet II (Paddle) 50 1% SLS in water 900 15, 30, 45 and 60 09/02/2010
Bosutinib Monohydrate Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 06/25/2015
45
Brexpiprazole Tablet II (Paddle) 50 0.05 M Acetate buffer, pH 4.3 900 10, 15, 20, 30 and 10/20/2016
45
Brigatinib Tablet II (Paddle) 70 50 mM Potassium Phosphate 900 5, 10, 15, 20, 30 11/02/2017
Buffer, pH 7.2 and 45
Brimonidine Tartrate/Brinzolamide Ophthalmic Develop a method to 01/15/2015

Suspension characterize in vitro release
Brinzolamide Ophthalmic Develop a method to 09/01/2011

Brivaracetam Tablet II (Paddle 50 Phosphate Buffer, pH 6.4 2.5 and 5 mg 5, 10, 15, 20 and 30 07/28/2016
tablets: 500 mL; 10,
25, 50, 75 and 100
mg tablets: 900 mL
Bromocriptine Mesylate Tablet Refer to USP 07/25/2007
8 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Budesonide Tablet (Extended II (Paddle) 100 Acid Stage: 0.1 M HCl Acid Stage: 500 mL Acid Stage: 2 hours; 04/02/2015
Release) containing 0.5% Macrogol ; Buffer Stage: 1000 Buffer Stage: 1, 2,
Cetostearyl Ether; Buffer Stage: mL 4, 6, 8 and 10 hours
pH 7.2 phosphate buffer
containing 0.5% Macrogol
Cetostearyl Ether.
Budesonide Capsule II (Paddle) with 75 Acid stage: 0.1 N HCl; Buffer Acid stage: 1000; Acid stage: 2 hours; 02/25/2015
sinker stage: Phosphate Buffer, pH Buffer stage: 1000 Buffer stage: 0.25,
7.5 0.5, 1, 2, 4, 6 and 8
hours
Bumetanide Tablet Refer to USP 07/14/2008
Buprenorphine Film, Transdermal VI 50 0.9% Sodium Chloride at 32°C 600 0.5,1, 2, 4, 6, 8,12, 05/09/2013
(Extended Release) (Cylinder) with 16 and 24 hours
adapter, if
needed
Buprenorphine HCl Implant II (Paddle 50 Water 900 1, 4, 12, 24, 36, 48, 07/28/2016
72, 96, 120, 144
and 168 hours
Buprenorphine HCl Film (Buccal) I (Basket) 100 100 0.05M NaH2PO4.H2O 60 10, 15, 20, 30, 45 10/20/2016
mL round Phosphate Buffer, pH 4.5 and 60
bottom vessel
Buprenorphine HCl Tablet (Sublingual) I (Basket) 100 Water 500 2, 5, 8, 10, 15, and 04/09/2007
until at least 80% of
the labeled content
is dissolved
Buprenorphine HCl/Naloxone HCl Film (Sublingual) V (Paddle over 100 Acetate Buffer, pH 4.0 (12.5mM 900 1, 2, 3, 5, 7 and 10 10/31/2013
Disk) with 56 Sodium acetate trihydrate and
mm, 40 mesh 60mM glacial acetic acid.
stainless steel Adjust the pH with glacial acetic
disk. acid or ammonium hydroxide).
Buprenorphine HCl/Naloxone HCl Tablet (Sublingual) I (Basket) 100 Water 500 1, 3, 5, 7.5, 10, 15 07/01/2010
and 20
Bupropion HCl Tablet Refer to USP 08/15/2013
Bupropion HCl Tablet (Extended Refer to USP 07/25/2007

Release)
Bupropion Hydrobromide Tablet (Extended I (Basket) 75 0.1 N HCl 900 1, 2, 4, 6, 8 and 10 06/10/2009
Release) hours
Buspirone Hydrochloride Tablet Refer to USP 07/21/2009
Busulfan Tablet II (Paddle) 50 Water (Deaerated) 500 5, 10, 15 and 30 07/14/2008
Cabergoline Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15 and 30 01/20/2004
Cabozantinib S-Malate Tablet II (Paddle 75 0.01 N HCl with 0.375% Triton 900 5, 10, 15, 20 and 30 07/28/2016
X-100 (degassed)
Cabozantinib S-Malate Capsule II (Paddle) with 75 0.01 N HCl with 0.5% Triton 900 5, 10, 15, 20 and 30 06/02/2016
sinker X-100 (degassed)
Calcifediol Capsule (Extended II (Paddle) with 75 0.5% SDS in 5 mM Sodium 500 1, 2, 4, 6, 8, 10 and 10/20/2016
Release) sinker Dihydrogenphosphate 12 hours
Monohydrate, pH 6.8
Calcitriol Capsule Develop a quantitative rupture 06/03/2008

test
Calcium Acetate Capsule II (Paddle) 50 Water 900 5, 10, 15, 20 and 30 07/21/2009
Calcium Acetate Tablet Refer to USP 01/14/2008
9 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Canagliflozin Tablet II (Paddle) 75 0.75 % sodium lauryl sulfate 600 5, 10, 15, 20 and 30 06/02/2016
(SLS) in water
Canagliflozin (Can)/ Metformin HCl Tablet (Extended Met: I (Basket, Met: 100: Can:100 Met: Simulated Gastric Fluid Met: 900: Can: 900 Met: 1, 2, 4, 6, 8 10 12/22/2016
(Met) Release) 40 mesh): Can: [SGF] without enzyme, pH 1.2; and 12 hours: Can:
I (Basket, 10 Can: 0.1% (w/v) polysorbate 20 10, 15, 20, 30, 45
mesh [with in 0.05 M sodium phosphate and 60 minutes;
option of tablet buffer pH 6.8 ( 50 mg); 0.2%
holder]) (w/v) polysorbate 20 in 0.05 M
sodium phosphate buffer pH
6.8 (150 mg)
Canagliflozin/Metformin HCl Tablet II (Paddle) Canagliflozin: 75; Canagliflozin (50 mg): 0.025 % Canagliflozin (50 Canagliflozin: 10, 05/28/2015
Metformin: 50 Polysorbate 20; Canagliflozin mg): 900; 15, 20, 30 and 45;
(150 mg):0.075 % Polysorbate Canagliflozin (150 Metformin: 5, 10,
20; Metformin: Phosphate mg): 900 ; 15, 20 and 30
buffer, pH 6.8 Metformin: 1000
Candesartan Cilexetil (16 mg, 8 mg Tablet II (Paddle) 50 0.35% Polysorbate 20 in 0.05 900 10, 20, 30, 45 and 06/20/2007
and 4 mg) M Phosphate Buffer, pH 6.5 60
Candesartan Cilexetil (32 mg) Tablet II (Paddle) 50 0.70% Polysorbate 20 in 0.05 900 10, 20, 30, 45 and 06/20/2007
M Phosphate Buffer, pH 6.5 60
Candesartan Tablet II (Paddle) 50 0.35% Polysorbate 20 in 900 10, 20, 30, 45 and 01/29/2010
Cilexetil/Hydrochlorothiazide phosphate buffer pH 6.5 60
(16/12.5 mg)
Candesartan Tablet II (Paddle) 50 0.70% Polysorbate 20 in 900 15, 20, 30, 45 and 01/29/2010
Cilexetil/Hydrochlorothiazide phosphate buffer pH 6.5 60
(32/12.5 mg and 32/25 mg)
Capecitabine Tablet Refer to USP 11/02/2017
Captopril Tablet Refer to USP 10/20/2016
Carbamazepine Suspension II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 01/20/2004
60
Carbamazepine Tablet Refer to USP 12/24/2015
Carbamazepine Tablet (Chewable) II (Paddle 75 1% SLS in Water 900 15, 30, 45, 60 and 12/23/2010
90
Carbamazepine Capsule (Extended II (Paddle) 75 First 4 hours: Dilute Acid, pH First 4 h: 900. After 1, 2, 4, 6, 8, 10 and 09/01/2011
Release) 1.1. After 4 hours: Phosphate 4 h: 900 12 hours
Buffer, pH 7.5 with 0.1%
sodium lauryl sulfate (SLS).
Carbamazepine Tablet (Extended Refer to USP 01/14/2008

Release)
Carbidopa Tablet I (Basket) 50 0.1 N HCl 750 10, 15, 20, 30 and 08/14/2014
45
Carbidopa/Entacapone/Levodopa Tablet I (Basket) Carbidopa and For both Carbidopa and Carbidopa and 10, 20, 30, 45 and 01/03/2007
Levodopa: 50; Levodopa: 0.1 N HCl, For Levodopa: 750 ml. 60
Entacapone: 125 Entacapone: Phosphate buffer Entacapone: 900 ml
pH 5.5
Carbidopa/Levodopa Suspension (Enteral) II (Paddle) 25 0.05 M Sodium Acetate Buffer, 500 5, 10, 15, 20, 30, 40 10/20/2016
pH 4.5 and 60
Carbidopa/Levodopa Tablet (Extended II (Paddle) 50 0.1 N HCl 900 0.5, 0.75, 1, 1.5, 2, 08/15/2013
Release) 2.5, 3 and 4 hours
10 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Carbidopa/Levodopa Capsule (Extended I (Basket) 75 Acid stage: Simulated Gastric Acid stage: 500 mL Acid stage: 30, 60 04/07/2016
Release) Fluid [SGF] without enzyme; [for 23.75/95 mg and 120 minutes;
Buffer stage: pH 7.0, 50 mM strength], 900 mL Buffer stage: 15, 30,
Phosphate Buffer [other strengths]; 60, 90, 120, 180
Buffer stage:500 mL and 240 minutes
[for 23.75/95 mg
strength], 900 mL
[other strengths]
Carbidopa/Levodopa Tablet (Orally II (Paddle) 50 0.1 N HCl 750 5, 10, 15, 30, and 07/25/2007
Disintegrating) 45
Carbidopa/Levodopa Tablet Refer to USP 01/14/2008
Carbinoxamine Maleate Suspension (Extended II (Paddle) 50 0.4 M Phosphate Buffer 900 [ 895 mL 0.4 M 0.5, 1, 2, 3, 4, 6, 8 06/02/2016
Release) Buffer +5 mL and 12 hours
Suspension]
Carglumic Acid Tablet II (Paddle) 100 0.05M Phosphate Buffer, pH 750 5, 10, 15, 20 and 30 08/15/2013
6.8
Cariprazine HCl Capsule I (Basket) 100 Sodium Acetate Buffer, pH 5.0 500 5, 10, 15, 20, 30 06/30/2016
(degas) and 45
Carisoprodol Tablet Refer to USP 01/29/2010
Carvedilol Tablet II (Paddle) 50 SGF without enzyme 900 10, 20, 30 and 45 01/21/2004
Carvedilol Tablet Refer to USP 12/24/2015
Carvedilol Phosphate Capsule (Extended II (Paddle) 100 0.1 N HCl 900 1, 2, 4, 6, 8, 12, 18 10/31/2013
Release) and 24 hours
Carvedilol Phosphate Capsule (Extended II (Paddle) 100 0.1 N HCl 900 1, 4, 8, 12, 18 and 04/02/2009
Release) 24 hours
Cefaclor Capsule Refer to USP 03/03/2011
Cefaclor Tablet (Chewable) Refer to USP 03/03/2011
Cefaclor Tablet (Extended Refer to USP 03/03/2011

Release)
Cefadroxil Tablet Refer to USP 09/02/2010
Cefadroxil Capsule Refer to USP 09/02/2010
Cefadroxil Suspension II (Paddle) 25 Water 900 5, 10, 15, 30 and 45 07/25/2007
Cefdinir Capsule II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 30 and 45 07/25/2007
Cefdinir Suspension II (Paddle) 50 0.05 M Phosphate buffer, pH 900 10, 20, 30 and 45 04/09/2007
6.8
Cefditoren Pivoxil Tablet II (Paddle) 75 Simulated Gastric Fluid without 900 5, 10, 15, 20 and 30 01/15/2010
enzyme
Cefixime Suspension II (Paddle) 50 0.05 M Phosphate buffer, pH 900 10, 20, 30 and 45 04/09/2007
7.2
Cefixime Tablet Refer to USP 12/23/2010
Cefixime Tablet (Chewable) II (Paddle 25 Phosphate Buffer, pH 7.2 900 10, 15, 20, 30, and 12/23/2010
45
Cefixime Capsule I (Basket) 100 0.05 M Phosphate Buffer, pH 900 10, 20, 30, 45 and 08/15/2013
7.2 60
Cefpodoxime Proxetil Suspension II (Paddle) 50 Glycine Buffer (0.04 M) pH 3.0 900 10, 20, 30 and 45 12/20/2005
Cefpodoxime Proxetil Tablet Refer to USP 07/25/2007
11 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Cefprozil Tablet Refer to USP 07/25/2007
Cefprozil Tablet Refer to USP 10/04/2012
Cefprozil For Oral Suspension II (Paddle) 25 Water 900 5, 10, 15, 20 and 10/04/2012
30
Cefprozil Monohydrate Suspension II (Paddle) 25 Water (deaerated) 900 5, 10, 15 and 30 01/21/2004
Ceftibuten Dihydrate Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 1000 10, 20, 30 and 45 01/21/2004
7.0
Cefuroxime Axetil Tablet Refer to USP 07/25/2007
Celecoxib Capsule II (Paddle) 50 mg, 100 mg and Tier 1 Medium: 0.04 M tribasic Tier 1: 1000 mL Tier 10, 20, 30, 45 and 07/01/2010
200 mg: 50 rpm; sodium phosphate (pH 12) with 2: 750 mL (initial) 60
400 mg: 75 rpm 1% SLS. Tier 2 Initial Medium: 1000 mL (final)
750 mL of simulated gastric
fluid, USP (includes pepsin); At
20 minutes, while stirring, add
180 mL of appropriate
concentrations of SLS solution
(for a final concentration of 1%
SLS). Add about 70 mL of 1.2
N NaOH to adjust the pH to 12.
Cephalexin Suspension II (Paddle) 25 Water 900 5, 10, 20, and 30 07/25/2007
Cephalexin Capsule Refer to USP 04/02/2009
Ceritinib Capsule II (Paddle) 60 0.01 M HCl (degassed) 900 08/27/2015
Cetirizine Capsule (Soft-Gelatin) II (Paddle) 50 25 mM pH 6.8 phosphate buffer 900 5, 10, 15, 20, 30 01/15/2015
and 45
Cetirizine HCl Tablet (Regular & II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 03/04/2006
Chewable)
Cetirizine HCl Tablet (Orally Refer to USP 03/17/2016

Disintegrating)
Cetirizine HCl/Pseudoephedrine Tablet (Extended I (Basket) 100 0.1 N HCl 500 0.17, 0.25, 0.5, 1, 2, 06/18/2007
HCl Release) 6 and 8 hours
Cevimeline HCL Capsule II (Paddle) with 50 0.1 N HCl 900 5, 10, 15, and 30 01/26/2006
option to use a
sinker
Chlorambucil Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, and 45 08/17/2006
Chlordiazepoxide HCl/ Clidinium Capsule Refer to USP (provide 03/02/2017

Bromide individual unit data).
Chlorothiazide Suspension Develop a dissolution method 03/07/2019
Chlorpheniramine Maleate Tablet (Extended III 27 dpm Row 1: Test Fluid 1 (0.1N HCl) Row 1: 250 mL. 1 hour for test fluid 07/25/2007
Release) (Reciprocating for 1st hour. Row 2: Test fluid 2 Row 2: 250 mL 1, and 4 hours for
Cylinder) (Phosphate Buffer, pH 7.5) for test fluid 2
5th hour
Chlorpheniramine Maleate/Codeine Tablet (Extended II (Paddle) 50 Simulated gastric fluid (SGF) 900 0.5, 1, 2, 4, 6, 8 and 10/20/2016
Phosphate Release) without enzyme (pH 1.2) 12 hours
Chlorpheniramine Tablet II (Paddle) 50 50 mM Potassium Phosphate 900 5, 10, 15, 20 and 30 06/25/2015
Maleate/Ibuprofen/Phenylephrine Buffer, pH 6.5 (degassed)
HCl
Chlorpheniramine Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 10, 20, 30 and 45 02/20/2004
Maleate/Ibuprofen 6.5
/Pseudoephedrine HCl
12 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Chlorpheniramine Polistirex/ Suspension (Extended II (Paddle) 50 Acid Stage: 0.1 N HCl; Buffer Acid Stage: 500 mL; Acid Stage: 1 hour; 03/17/2016
Codeine polistirex Release) Stage: pH 6.8 Phosphate Buffer Buffer Stage: 900 Buffer Stage: 1, 2,
[500 mL 0.1 N HCl for 1 hour, mL 4, 6, 8 and 12 hours
followed by addition of 400 mL
of 0.2M NaH2P04 to pH 6.8]
Chlorpheniramine Capsule (Extended II (Paddle) 50 Simulated Intestinal Fluid 500 1, 4, 12, and 24 11/25/2008
Polistirex/Hydrocodone Polistirex Release) without enzyme hours
Chlorpheniramine Extended Release Oral II (Paddle) 50 Simulated Gastric Fluid (SGF) 495 1, 2, 3, 6, 8, 12, 16 06/30/2011
Polistirex/Hydrocodone Polistirex Suspension at 37ºC ± 0.5ºC and 24 hours
Chlorpromazine HCl Tablet Refer to USP 01/05/2012
Chlorthalidone Tablet Refer to USP 04/15/2008
Chlorzoxazone Tablet Refer to USP 01/14/2008
Cholic Acid Capsule II (Paddle) with 100 Phosphate Buffer, pH 6.8 500 mL for 50 mg 5, 10, 15, 20 and 30 03/17/2016
sinker capsule; 900 mL for
250 mg capsule
Choline Fenofibrate Capsule (Delayed II (Paddle) 50 Acid Stage: 0.05M Sodium Acid stage: 500; Acid stage: 120; 07/01/2010
Release) Phosphate, pH 3.5 ± 0.05; Buffer stage: 900 Buffer stage: 15, 30,
Buffer Stage: 0.05 M Sodium 60, 90, 120, 240
Phosphate, pH 6.8 ± 0.05 and 360
Ciclopirox Topical Suspension Develop a method to 03/25/2010

Cilostazol Tablet II (Paddle) 75 0.3% SLS in water 900 15, 30, 45, 60 and 08/17/2006
90
Cinacalcet HCl Tablet II (Paddle) 75 0.05 N HCl 900 10, 20, 30 and 45 01/26/2006
Ciprofloxacin Injectable Suspension IV (Flow through Flow @ 6 mL/min 50 mM Acetate Buffer, pH 4.5 480 5, 10, 15, 20, 30, 03/17/2016
[Otic] cell-closed loop) @37°C ± 0.5 [use glass beads; 45, 60 and 75
/ 22 mm sample volume: 100 µl]
Ciprofloxacin Oral Suspension II (Paddle) 100 0.05 M Acetate Buffer with 900 10, 20, 30 and 45 03/25/2010
0.025% Brij35 (polyoxyethylene
lauryl ether), pH 4.5
Ciprofloxacin HCl Tablet Refer to USP 09/02/2010
Ciprofloxacin HCl Tablet (Extended I (Basket) 100 0.1 N HCl 900 1, 2, 4, and 7 hours 01/14/2008
Release) or until at least 80%
released
Ciprofloxacin HCl/Hydrocortisone Otic Suspension Develop a method to 09/01/2011

Ciprofloxacin/Ciprofloxacin HCl Tablet (Extended II (Paddle) 50 0.1 N HCl 900 15, 30, 60, and 120 01/14/2008
(AB) Release)
Ciprofloxacin/Dexamethasone Otic Suspension Develop a method to 03/17/2016

Citalopram HBr Tablet Refer to USP 01/14/2008
Citalopram Hydrobromide Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 10/06/2008
Clarithromycin Tablet Refer to USP 07/25/2007
Clarithromycin Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 10, 20, 30, 45 and 01/23/2004
6.8 60
Clarithromycin Tablet (Extended Refer to USP 10/06/2008

Release)
Clindamycin HCl Capsule Refer to USP 09/01/2011
13 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Clobazam Tablet II (Paddle) 75 0.1 N HCl (degassed) 900 5, 10, 20, 30, 45 07/31/2013
and 60
Clobazam Oral Suspension II (Paddle) 75 0.1 N HCl (degassed) 900 5, 10, 15, 20, 25 07/31/2013
and 30
Clomiphene Citrate Tablet Refer to USP 08/15/2013
Clomipramine HCl Capsule Refer to USP 08/27/2015
Clonazepam Tablet Refer to USP 04/08/2010
Clonazepam Tablet (Orally II (Paddle) 50 Water 900 5, 10, 15, 30, and 07/25/2007
Disintegrating) 45
Clonidine Transdermal Refer to USP 02/18/2009
Clonidine ( 0.1 mg) Tablet (Extended II (Paddle) with 50 Acid stage: 0.01 N HCl; Buffer Acid stage: 500; Acid stage: 1 and 2 01/26/2012
Release) sinker stage: Phosphate Buffer, pH Buffer stage: 500 hours; Buffer stage:
7.0 1, 2, 4, 6, 10, 14
and 16 hours
Clonidine ( EQ. 0.17 mg and EQ. Tablet (Extended II (Paddle) 50 500 mL 0.1N HCl for the 1st Acid stage: 500; 1, 2, 3, 6, 9, 12, 16, 07/01/2010
0.26 mg) Release) hour, then add 400 mL 0.27M Buffer stage: 900 20 and 24 hours
Sodium Phosphate (Dibasic)
buffer solution
Clonidine HCl Tablet Refer to USP 06/18/2007
Clonidine HCl (0.1 mg & 0.2 mg) Tablet (Extended II (Paddle) with 50 Acid stage: 0.01 N HCl; Buffer Acid stage: 500; Acid stage: 1 and 2 08/27/2015
Release) sinker stage: Phosphate Buffer, pH Buffer stage: 500 hours; Buffer stage:
7.0 1, 2, 4, 6, 10, 14
and 16 hours
Clopidogrel Bisulfate Tablet Refer to USP 07/25/2007
Clorazepate Dipotassium Tablet Refer to USP 01/31/2013
Clotrimazole Tablet (Vaginal) II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/24/2004
Clotrimazole Lozenge Refer to USP 10/06/2008
Clozapine Tablet (Orally II (Paddle 50 RPM (12.5 mg, pH 4.5 Acetate Buffer 900 5, 10, 15, 20, and 06/09/2011
Disintegrating) 25 mg and 100 mg); 30
75 RPM (150 mg
and 200 mg)
Clozapine Suspension II (Paddle) 50 Acetate Buffer (pH 4.0) 900 5, 10, 15, 20 and 30 05/28/2015
Clozapine Tablet Refer to USP 07/21/2011
Cobicistat Tablet II (Paddle) 75 50 mM Sodium Acetate Buffer, 900 5, 10, 15, 20 and 30 08/27/2015
pH 4.5
Cobicistat (Cobi)/ Darunavir Tablet Cobi: II Cobi: 75; Drv:75 Cobi: 0.05 M Citrate Phosphate Cobi: 900 mL; Drv: Cobi: 5, 10, 15, 20 10/20/2016
Ethanolate (Drv) (Paddle): Drv: II Buffer, pH 4.2; Drv: 0.05 M 900 mL and 30; Drv: 10, 15,
(Paddle) Sodium Phosphate Buffer, pH 20, 30 and 45
3.0, 2% Tween 20
Cobicistat/Elvitegravir/ Tablet II (Paddle) 100 0.05 M sodium citrate buffer pH 1000 5, 10, 15, 20 and 30 10/20/2016
Emtricitabine/Tenofovir 5.5 containing 2.0% w/v
Alafenamide Fumarate polysorbate 80
Cobicistat/Elvitegravir/Emtricitabine Tablet II (Paddle) with 100 0.01 N HCl with 2% w/w 1000 5, 10, 15, 20 and 30 06/25/2015
/Tenofovir Disoproxil Fumarate sinker Polysorbate 80
Cobimetinib Fumarate Tablet II (Paddle) 50 50 mM Acetate Buffer, pH 4.5 900 5, 10, 15, 20 and 30 06/30/2016
Codeine Sulfate Tablet Refer to USP 09/01/2011
14 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Colchicine Capsule II (Paddle) 75 Deionized Water with 2% 500 5, 10, 15, 20 and 30 12/22/2016
Sodium Lauryl Sulfate (SLS)
Colchicine Tablet Refer to USP 08/05/2010
Colesevelam HCl Tablet Disintegration Testing as per 10/28/2010

USP <701> in various media
such as deionized water,
simulated gastric fluid and
simulated intestinal fluid.
Crizotinib Capsule I (Basket) 100 0.1N HCl (degassed) 900 5, 10, 15, 30 and 04/14/2016
45
Crofelemer Tablet (Delayed II (Paddle) 75 Acid stage: 0.1 N HCl; Buffer Acid stage: 750; Acid stage: 2 hours; 06/02/2016
Release) stage: Sodium phosphate Buffer stage: 1000 Buffer stage: : 5, 10,
buffer, pH 6.8 20, 30 and 45
minutes
Cyclobenzaprine Capsule (Extended Refer to USP 10/20/2016

Release)
Cyclobenzaprine HCl Tablet Refer to USP 07/25/2007
Cyclophosphamide Tablet I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45 and 01/24/2004
60
Cycloserine Capsule Refer to USP 05/09/2013
Cyclosporine Capsule Refer to USP 03/17/2016
Cyclosporine (100 mg) (AB1) Capsule (Liquid filled) II (Paddle) 75 0.1 N HCl containing 4 mg of 1000 10, 20, 30, 45, 60 01/14/2008
N,N-dimethydodecylamine- and 90
N-oxide per mL
Cyproheptadine HCl Tablet Refer to USP 05/28/2015
Cysteamine Bitartrate Capsule (Delayed I (Basket) 75 Acid stage: 0.1N HCl; Buffer Acid stage: 1000; Acid stage: 2 hours; 08/27/2015
Release) stage: 0.05 M Sodium Buffer stage: 1000 Buffer stage: : 5, 10,
Phosphate buffer, pH 6.8 15, 20 and 30
minutes
Cysteamine Bitartrate Capsule I (Basket) 75 0.1 N HCl 900 10, 20, 30 and 45 01/24/2004
Dabigatran Etexilate Mesylate Capsule I (Basket) for 75 100 0.01 N HCl (pH 2.0) 900 10, 20, 30, and 45 09/22/2011
strength: I
(Basket with
modified
diameter of 24.5
mm) for 150 mg
strength:
Dabrafenib Mesylate Capsule II (Paddle) 65 0.2% Cetyl trimethylammonium 900 10, 15, 20, 30 and 05/28/2015
bromide (CTAB) in 0.1N HCl 45
Daclatasvir Dihydrochloride Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8 with 1000 10, 15, 20, 30 and 03/17/2016
0.75% Brij 35 45
Dalfampridine Tablet (Extended II (Paddle) 50 Phosphate Buffer, pH 6.8 900 0.5, 1, 2, 4, 6, 8, 10 06/07/2012
Danazol Capsule Refer to USP 06/18/2007
Dantrolene Sodium For suspension II (Paddle) 50 0.5% Benzalkonium Chloride in 900 0.5, 1, 2, 3, 5 and 03/02/2017
(Intravenous ) water 10 minutes
Dantrolene Sodium Capsule I (Basket) 100 0.5% Hyamine 10X in water, 900 10, 20, 30, 40 and 01/27/2004
adjust to pH 6.8 with 0.1 N 60
KOH or 0.1 N HCl
Dapagliflozin Propanediol Tablet II (Paddle) 60 Acetate Buffer, pH 4.5 1000 5, 10, 15, 20 and 30 05/28/2015
15 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Dapagliflozin Propanediol/ Tablet (Extended I (Basket- 20 100 Phosphate Buffer, pH 6.8 1000 Dapagliflozin: 5, 10, 08/27/2015
Metformin HCl Release) mesh) 15, 20, 30 and 45
minutes:
Metaformin: 0.5, 1,
2, 3, 4, 6, 8, 10 and
12 hours
Dapsone Gel (Topical) Develop a method to 07/28/2016

Dapsone Tablet Refer to USP 12/23/2010
Darifenacin Hydrobromide Tablet (Extended I (Basket) 100 0.01N HCl Comparative 900 1, 4, 8, 12, 16, 20 01/20/2006
Release) dissolution data should also be and 24 hours
provided in 900 ml pH 4.5
buffer, pH 6.8 buffer, and water
using Apparatus I (Basket) at
100 RPM.
Darunavir Ethanolate Tablet II (Paddle) 75 2% Tween-20 in 0.05 M 900 10, 20, 30, and 45 09/13/2007
Sodium Phosphate Buffer, pH
3.0
Darunavir Ethanolate Oral Suspension II (Paddle) 75 0.05% Polysorbate 20 in 0.05M 900 5, 10, 15, 20, 30 06/25/2015
Phosphate Buffer, pH 6.8 and 45
Dasabuvir Na/ Tablet (Extended III 25 dpm 15 mM 250 Ombitasvir/ 10/20/2016

Ombitasvir/Paritaprevir/Ritonavir Release) (Reciprocating hexadecyltrimethylammonium Paritaprevir/
Cylinder [40 bromide (CTAB) in 0.03M Ritonavir: 10, 15,
mesh (for Sodium Phosphate Buffer, pH 20, 30, 45, 60 and
bottom and top 6.8 90
of the inner minutes;Dasabuvir:
tube)] 1, 2, 3, 6, 9, 12, 15,
18, 21 and 24 hours
Dasatinib Tablet II (Paddle) 60 pH 4.0 Acetate buffer 1000 10, 15, 30 and 45 10/30/2009
containing 1% Triton X-100
Deferasirox Tablet (for Oral II (Paddle) 50 Phosphate buffer pH 6.8 with 900 10, 20, 30 and 45 06/21/2006
Suspension) 0.5% Tween 20
Deferasirox Tablet II (Paddle) 75 0.5% Tween 20 in Phosphate 900 5, 10, 15, 20 and 30 03/17/2016
Buffer, pH 6.8
Deferasirox Granule II (Paddle) 75 Phosphate Buffer, pH 6.8 with 900 5, 10, 15, 20 and 30 11/02/2017
0.5% Tween 20
Deferiprone Tablet II (Paddle) 50 0.1 N HCl 1000 5, 10, 20, 30, 45 06/25/2015
and 60
Delafloxacin Meglumine Tablet II (Paddle) 60 0.05 M Phosphate Buffer, pH 900 5, 10, 15, 20 and 30 11/16/2017
7.4 (degassed)
Delavirdine Mesylate Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 10, 20, 30, 45 and 12/03/2007
6.0 containing 0.6% w/v SDS 60
Demeclocycline HCl Capsule Refer to USP 07/25/2007
Demeclocycline HCl Tablet Refer to USP 07/25/2007
Desipramine HCl Tablet Refer to USP 01/31/2013
Desloratadine Tablet (Orally II (Paddle) 50 0.1 N HCl 900 3, 6, 10, 15 06/18/2007

Disintegrating)
Desloratadine Tablet II (Paddle) 50 0.1 N HCl 500 15, 20, 30 and 45 03/04/2006
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Recommended
Sampling Times Date
Desloratadine/Pseudoephedrine Tablet (Extended II (Paddle) 50 First hour: 0.1 N HCl; After 1 1000 For Desloratadine: 04/02/2009
Sulfate (2.5 mg/120 mg) Release) hour: 0.1M Potassium 10, 20, 30 and 45;
Phosphate Buffer pH 7.5 For
Pseudoephedrine
Sulfate: 1, 2, 6 and
8 hours
Desloratadine/Pseudoephedrine Tablet (Extended II (Paddle) 50 First hour: 0.1 N HCl; After 1 1000 For Desloratadine: 04/02/2009
Sulfate (5 mg/240 mg) Release) hour: 0.1M Potassium 10, 20, 30 and 45;
Phosphate Buffer pH 7.5 For
Pseudoephedrine
Sulfate: 1, 2, 4, 8,
16 and 24 hours
Desmopressin Acetate Tablet II (Paddle) 75 Water (deaerated) 500 10, 20, 30 and 45 12/15/2005
Desogestrel/Ethinyl Estradiol Tablet Refer to USP 11/04/2008
Desvenlafaxine Succinate Tablet (Extended I (Basket) 100 0.9% NaCl in water 900 1, 2, 4, 8, 12, 16, 20 04/02/2009
Deutetrabenazine Tablet II (Paddle) over 75 pH 3.0 Acid Phthalate Buffer 500 0.5, 1, 1.5, 2, 3, 4, 5 11/02/2017
a disk (62 mm and 6 hours
with 16 mesh)
Dexamethasone Tablet Refer to USP 04/02/2009
Dexamethasone Implant (Intravitreal) VII (with 30 cycles per min Phosphate Buffered Saline 30 12, 24, 48, 72, 96, 10/21/2010
reciprocating 50 containing 0.05 g/L sodium 120, 144, 168, 192,
mesh baskets) dodecyl sulfate at 45 ± 0.5°C 216 and 240 hours
Dexamethasone/Neomycin Sulfate/ Ophthalmic Develop a method to 02/15/2018

Polymyxin B Sulfate Suspension characterize in vitro release
Dexamethasone/Tobramycin Ophthalmic Develop a method to 04/02/2009

Dexbrompheniramine Tablet (Extended III 12 dpm 0.02N HCl (2 hours) followed 250 0.5, 1, 2, 3, 4, 6 and 05/28/2015
Maleate/Pseudoephedrine Sulfate Release) (Reciprocating by 0.05M Phosphate Buffer pH 8 hours
Cylinder) 7.5
Dexlansoprazole Capsule (Delayed I (Basket) 100 Acid Stage: 0.1 N HCl, Buffer Acid Stage: 500; Acid Stage: 120; 08/05/2010
Release) Stage: pH 7.0 Phosphate Buffer Buffer stage: 900 Buffer Stage: 10,
with 5 mM SLS 20, 40, 50, 60 , 75,
105 and 120
Dexlansoprazole Tablet (Delayed I (Basket -100 100 Acid Stage: 0.1 N HCl; Buffer Acid Stage: 500 mL; Acid Stage: 120; 07/28/2016
Release, Orally mesh) Stage: pH 7.2 Phosphate Buffer Buffer Stage: 900 Buffer Stage: 10,
Disintegrating) with 5 mM Sodium lauryl sulfate mL 15, 20, 30, 50, 60,
75 and 90
Dexmethylphenidate HCl Tablet I (Basket) 100 Water 900 10, 15, 30, and 45 06/18/2007
Dexmethylphenidate HCl Capsule (Extended I (Basket) 100 First 2 hours: 0.01 N HCl, Acid: 500, Buffer: 0.5, 1, 2, 4, 6, and 01/14/2008
Release) Hours 2-10: Phosphate Buffer, 500 10 hours
pH 6.8
Dextroamphetamine Sulfate Capsule (Extended I ( Basket) 100 0.1 N HCl 500 1, 4, 8 and 12 hours 11/25/2008
Release)
Dextroamphetamine Sulfate Tablet I (Basket) 100 Water 500 10, 20, 30, 45 and 01/31/2013
60
Dextromethophan HBr/Guaifenesin Tablet (Extended I (Basket) 50 0.01 N HCl 900 1, 2, 6, and 12 11/25/2008
Release) hours
Dextromethorphan Capsule I (Basket) 100 pH 1.2, Simulated Gastric Fluid 900 5, 10, 15, 20 and 30 01/05/2012
Hydrobromide/Quinidine Sulfate without enzyme
Dextromethorphan Polistirex Suspension (Extended II (Paddle) 50 0.1 N HCl 500 30, 60, 90 and 180 10/06/2008
Release)
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Recommended
Sampling Times Date
Diazepam Gel (Rectal) II (Paddle) 50 0.05 M Phosphate Buffer, pH 500 5, 10, 15, 30 and 45 04/02/2009
6.8
Diazepam Tablet Refer to USP 07/25/2007
Diazoxide Oral suspension Develop a dissolution method 02/14/2014
Diclofenac Capsule I (Basket) 100 10 mM Citrate Buffer pH 5.5 900 5, 10, 20, 30 and 45 06/25/2015
with 0.05% Sodium Dodecyl
Sulfate (SDS)
Diclofenac Epolamine Topical patch V (Paddle over 50 pH 6.8 phosphate buffer at 32 ± 500 15, 30, 45, 60, 90, 10/21/2010
Disk) with a 0.5°C 120 and 180
watchdish (a
diameter of 6
cm)
Diclofenac Potassium Powder for II (Paddle 75 0.05M phosphate buffer 400 2.5, 5, 7.5 and 10 10/21/2010
Oral Solution (TriSodium Phosphate
Dodecahydrate in 0.1 N HCl
and pH adjusted to 6.8)
Diclofenac Potassium Capsule II (Paddle 50 50 mM Phosphate buffer pH 900 10, 15, 20, 30 and 10/21/2010
6.8 45
Diclofenac Potassium Tablet II (Paddle) 50 SIF without enzyme 900 10, 20, 30, 45, 60 01/27/2004
and 90
Diclofenac Sodium Tablet (Extended Refer to USP 06/10/2009

Release)
Diclofenac Sodium Tablet (Delayed Refer to USP 06/10/2009

Release)
Diclofenac Sodium/Misoprostol Tablet (Delayed II (Paddle) 100 (diclo) 50 (miso) Diclofenac: Acid Stage: 0.1 N Diclo: Acid: 750 Diclo.: 120 (acid) 12/15/2005
Enteric Coated Release) (diclo) II HCl Buffer Stage: 750ml 0.1N Buffer:1000 Miso: 15, 30, 45 and 60
(Paddle) (miso) HCL+250ml 0.2M phos.buffer, 500 (Buffer). Miso:10, 20
pH 6.8 (Method A) Misoprostol: and 30
Water (deaerated)
Dicloxacillin Sodium Capsule Refer to USP 06/18/2007
Didanosine Tablet (Chewable) II (Paddle) 75 Water (deaerated) 900 10, 20, 30 and 45 01/26/2004
Didanosine Capsule (Delayed I (Basket) 100 Acid stage: 0.1 N HCl; Buffer 1000 Acid stage: 60, 90 01/26/2004
Release Pellets) stage: 0.1 N HCl:0.2M Tribasic and 120; Buffer
Sodium Phosphate (3:1), pH stage: 10, 20, 30, 45
6.8 and 60
Dienogest/Estradiol Valerate Tablet II (Paddle) 50 0.4% SLS in water 900 10, 15, 20, 30 and 06/07/2012
45
Diethylpropion HCl Tablet (Extended I (Basket) 100 Water (deaerated) 900 1, 3, 5, 7 and 9 05/20/2009
Release) hours
Diflunisal Tablet Refer to USP 04/15/2008
Digoxin Tablet Refer to USP 06/18/2007
Diltiazem HCl Tablet (Extended II (Paddle) 100 Phosphate Buffer, pH 5.8 900 2, 8, 14, and 24 02/19/2008
Release) hours
Diltiazem HCl (AB2) Capsule (Extended Refer to USP 02/19/2008

Release)

Release)

Release)
18 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Dimethyl Fumarate Capsule (Delayed II (Paddle) 100 Acid stage: 0.1 N HCl; Buffer Acid stage: 500; Acid stage: 2 hours; 06/02/2016
Release) stage: pH 6.8 Phosphate Buffer Buffer stage: 500 Buffer stage: 5, 10,
20, 30 and 45
Dinoprostone Vaginal Suppository Develop a method to 10/04/2012

Dinoprostone Vaginal Insert II (Paddle) 50 Deionized Water 500 0.25, 0.5, 1, 2, 2.5, 09/01/2011
(Extended Release) 3, 3.5, 4 and 5
hours
Diphenhydramine Citrate/Ibuprofen Tablet II (Paddle) 50 50 mM Phosphate Buffer, pH 900 10, 20, 30 and 45 01/14/2008
6.5
Diphenhydramine HCl/Ibuprofen Capsule I (Basket) 100 200 mM Phosphate Buffer, pH 900 10, 20, 30 and 45 01/14/2008
7.2
Dipyridamole Tablet Refer to USP 06/18/2007
Disopyramide Phosphate Capsule (Extended Refer to USP 11/04/2008

Release)
Disopyramide Phosphate Capsule Refer to USP 09/03/2008
Disulfiram Tablet II (Paddle) 100 2% SDS 900 15, 30, 45, 60, 75, 06/18/2007
90, 105, and 120
Divalproex Sodium Tablet (Extended Refer to USP 06/30/2016

Release)
Divalproex Sodium Capsule (Delayed Refer to USP 06/30/2016

Release)
Divalproex Sodium Tablet (Delayed Refer to USP 07/25/2007

Release)
Dofetilide Capsule I (Basket) 100 0.001 M HCL 900 10, 15, 30 and 45 01/20/2006
Dolasetron Mesylate Tablet Refer to USP 07/01/2010
Dolutegravir Na/Rilpivirine HCl Tablet II (Paddle) 75 1.0 % Tween 20 in 0.01 M HCl, 900 10, 15, 20, 30, 45 02/08/2018
pH 2.0 and 60
Dolutegravir Sodium (10 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer 900 5, 10, 15, 20, 30 10/18/2018
and 45
containing 0.15% w/v sodium and 45
dodecyl sulfate (SDS)
containing 0.25% w/v sodium and 45
dodecyl sulfate (SDS)
Donepezil HCl/Memantine HCl Capsule (Extended I (Basket) 100 pH 1.2 NaCl/HCl buffer 900 Donepezil: 5, 10, 05/28/2015
Release) 15, 20 and 30
minutes;
Memantine: 1, 2, 3,
4, 6, 8, 10 and 12
hours
Donepezil HCl Tablet Refer to USP 03/17/2016
Donepezil HCl Tablet (Orally II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 03/04/2006
Disintegrating (ODT))
Donepezil HCl (23 mg) Tablet II (Paddle 50 0.05 M Phosphate Buffer, pH 900 1, 2, 3, 4, 6, 8 and 12/23/2010
6.8 10 hours
Doxazosin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30, 45 and 01/27/2004
60
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Recommended
Sampling Times Date
Doxazosin Mesylate Tablet (Extended II (Paddle) 75 SGF without enzyme 900 1, 2, 4, 6, 8, 12 and 01/03/2007
Release) 16 hours
Doxepin HCl Capsule Refer to USP 08/05/2010
Doxepin HCl Tablet II (Paddle) 50 Simulated Gastric Fluid w/o 900 5, 10, 15, 20, 30 09/02/2010
enzyme (pH 1.1-1.3) and 45
Doxercalciferol Capsule Develop a quantitative rupture 06/03/2008

test
Doxorubicin HCl Injectable (Liposomal) Develop a method to 10/04/2012

characterize in vitro release,
starting at pH 6.00 ± 0.05 and
at 47ºC ± 0.5ºC. Replicate for
12 dosage vials.
Doxycycline Suspension II (Paddle) 25 0.01 N HCl 900 5, 10, 15 and 20 09/03/2008
Doxycycline Capsule (Delayed II (Paddle) 75 Dilute HCl, pH 1.1 for 2 hours Acid stage: 750; 1, 2, 2.5 , 3 and 4 10/06/2008
Release) and then add 200 mL of 0.1 N Buffer stage: 950 hours
NaOH in 200 mM Phosphate
Buffer. Adjust pH to 6.0 using 2
N HCl and/or 2N NaOH
Doxycycline Calcium Suspension Develop a dissolution method 03/07/2019
Doxycycline Hyclate Capsule Refer to USP 07/14/2008
Doxycycline Hyclate Tablet Refer to USP 03/17/2016
Doxycycline Hyclate ( 120 mg and Tablet (Delayed I (Basket) 100 Acid stage: 0.06 N HCl; Buffer Acid stage: 900 mL; Acid stage: 10, 20, 03/27/2018
60 mg) Release) stage: Neutralized Phthalate Buffer stage: 900 30, 45 and 60;
Buffer, pH 5.5 mL Buffer stage: 5, 10,
15, 20, 30 and 45
Doxycycline Hyclate ( 150 mg and Tablet II (Paddle) 75 Water 900 5, 10, 15, 20 and 30 05/28/2015
75 mg)
Doxycycline Hyclate ( 200 mg, 150 Tablet (Delayed Refer to USP 05/28/2015
mg, 100 mg, 80 mg and 75 mg) Release)
Doxycycline Hyclate ( 50 mg) Tablet (Delayed I (Basket) 100 Acid stage: 0.06 N HCl; Buffer 900 Acid stage: 5, 10, 05/28/2015
Release) stage: Neutralized Phthalate 15, 20 and 30;
Buffer, pH 5.5 Buffer stage: 5, 10,
15, 20 and 30
Doxylamine Succinate/Pyridoxine Tablet (Extended II (Paddle) 100 Acid stage: 0.1 N HCl: Buffer Acid stage: 1000 Acid stage: 5, 10, 01/19/2017
HCl Release) stage: 0.2M sodium phosphate mL; Buffer stage: 15, 30, 60, 120
buffer pH 6.8 1000 mL minutes; Buffer
stage: 5, 10, 15, 20
and 30 minutes
Dronabinol Capsule II (Paddle) 100 and 150 10% Labrasol in Water; (In 500 5, 10, 15, 30, 45, 01/31/2007
addition, the USP capsule 60, and until at least
rupture test should also be 80% of the labeled
conducted) content is released
Dronedarone HCl Tablet II (Paddle) with 75 pH 4.5 Phosphate buffer 1000 10, 15, 20, 30, 45, 02/25/2015
sinker 60, 90 and 120
Drospirenone/Estradiol Tablet II (Paddle) 50 Water 900 10, 20, 30, and 45 01/03/2007
Drospirenone/Ethinyl Estradiol Tablet Refer to USP 07/28/2016
Drospirenone/Ethinyl Tablet II (Paddle) 50 Phosphate buffer pH 6.8, saline 900 5, 10, 15, 20 and 30 07/28/2016
Estradiol/Levomefolate Calcium with 0.03 % ascorbic acid
Droxidopa Capsule I (Basket) 100 0.1N HCl 900 5, 10, 15, 20 and 30 05/28/2015
Duloxetine HCl Capsule (Delayed Refer to USP 03/17/2016

Release)
20 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Dutasteride Capsule (Soft-Gelatin) II (Paddle) 50 Tier I: Dissolution Medium: 0.1 900 15, 30, 45 and 60 08/05/2010
N HCI with 2% (w/v) sodium
dodecyl sulfate (SDS) (900 mL)
Tier II: Dissolution Medium: 0.1
N HCI with pepsin (as per USP)
(450 mL) for the first 25
minutes, followed by addition of
0.1 N HCI with SDS (4% w/v)
(450 mL) for the remainder of
the dissolution test.
Dutasteride/Tamsulosin HCl Capsule Dutasteride: II Dutasteride: 75 Dutasteride::Tier I: Dissolution Dutasteride: 900. Dutasteride: 15, 30, 01/26/2012
(Paddle) with Tamsulosin: 50 Medium: 1%w/v Tamsulosin: Acid 45 and 60 minutes.
sinker. cetyltrimethylammonium stage: 750; Buffer Tamsulosin: Acid
Tamsulosin: II bromide (CTAB) in 0.1 N HCl. stage: 1000 Stage: 2 hours
(Paddle) Tier II: Dissolution Medium: 1% Buffer stage: 0.5, 1,
w/v CTAB in 0.1 N HCl with 2, 3, 5, 7 and 10
0.16% w/v pepsin. Tamsulosin:: hours
Acid Stage (0-2 hrs): 0.1 N HCl.
Buffer stage: Add 250 mL of 0.2
M Sodium Phosphate Tribasic,
Dodecahydrate pH 6.8
Efavirenz Capsule II (Paddle) A 50 1% Sodium Lauryl Sulfate in 900 15, 30, 45 and 60 03/22/2006
sinker may be water
used with
justification if
necessary.
Efavirenz Tablet II (Paddle) 50 2% SLS in water 1000 10, 15, 30, 45, 60 06/18/2007
Efavirenz 600 mg; Emtricitabine Tablet II (Paddle) 100 2% SLS in water 1000 10, 20, 30, and 45 01/03/2007
200 mg; Tenofovir Disoproxil
Fumarate 300 mg
Elbasvir/Grazoprevir Tablet I (Basket) 100 Phosphate Buffer, pH 6.8 with 900 10, 15, 20, 30, 45 07/28/2016
0.45% (w/v) Polysorbate 80 and 60
Eletriptan Hydrobromide Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 15 and 30 04/02/2009
Eliglustat Tartrate Capsule II (Paddle) with 75 0.1 N HCl 900 10, 15, 20, 30 and 05/28/2015
sinker 45
Eltrombopag Olamine Tablet II (Paddle) 50 0.5% Polysorbate 80 in 900 10, 15, 20, 30, 45, 06/07/2012
Phosphate Buffer, pH 6.8 and 60
Eltrombopag Olamine Suspension II (Paddle) 50 50 mM potassium phosphate in 750 4, 8, 12, 15 and 20 10/20/2016
water, pH 6.8 with 0.2%
polysorbate 80
Eluxadoline Tablet I (Basket) 100 0.05M Phosphate Buffer, pH 900 5, 10, 15, 20 and 30 03/17/2016
4.5
Elvitegravir Tablet II (Paddle) with 75 2.0% w/v Polysorbate 80 in 700 mL for 85 mg 10, 20, 30, 45 and 12/24/2015
sinker 0.01 N HCl (pH 2.0) at 37 ºC tablets; 1000 mL for 60
150 mg tablets 1000
mL for 150 mg
tablets
Empagliflozin Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 900 5, 10, 15, 20 and 30 05/28/2015
6.8
Empagliflozin/ Metformin HCl Tablet (Extended I (Basket) 100 Phosphate Buffer, pH 6.8 900 Metformin: 1, 2, 4, 01/19/2017
Release) 6, 8, 10 and 12
hours:
Empagliflozin: 10,
15, 20, 30, 45 and
60 minutes;
Empagliflozin/Linagliptin Tablet II (Paddle) 50 pH 6.8 Phosphate Buffer 900 10, 15, 20, 30 and 12/24/2015
45
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Recommended
Sampling Times Date
Empagliflozin/Metformin HCl Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20 and 30 06/30/2016
(degas)
Empagliflozin/Metformin Tablet II (Paddle) 50 Phosphate Buffer, pH 900 5, 10, 15, 20 and 30 10/20/2016
Hydrochloride 6.8 (deaerated)
Emtricitabine Capsule II (Paddle) 50 Tier 1: 0.1 N HCl Tier 2: 0.1 N 900 10, 20, 30 and 45 12/16/2005
HCl containing Pepsin 750,000
USP units/L. Tier 2 is used after
failure of Tier 1 testing
Emtricitabine/Rilpivirine Tablet II (Paddle 75 Rilpivirine (RPV): 0.5% RPV: 1000 mL; ETC 5, 10, 15, 20, 30 07/28/2016
HCl/Tenofovir Alafenamide Polysorbate 20 in 0.01 N HCl; and TAF: 500 mL and 45
Fumarate Emtricitabine (ETC) and
Tenofovir alafenamide (TAF):
50 mM Sodium Citrate, pH 5.5,
Emtricitabine/Rilpivirine Tablet II (Paddle) with 75 0.5%(w/w) polysorbate 20 in 1000 Emtricitabine and 01/15/2015
HCl/Tenofovir Disoproxil Fumarate sinker 0.01N HCl (pH 2.0) Tenofovir: 5, 10, 15,
20 and 30;
Rilpivirine: 10, 20,
30, 45, 60, 75, 90
and 120
Emtricitabine/Tenofovir Tablet II (Paddle 75 50 mM Sodium Citrate buffer, 500 5, 10, 15, 20, 30 07/28/2016
Alafenamide Fumarate pH 5.5 and 45
Emtricitabine/Tenofovir Disoproxil Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 30 and 45 01/03/2007
Fumarate
Enalapril Maleate Tablet Refer to USP 09/03/2008
Entacapone Tablet II (Paddle) 50 Phosphate Buffer, pH 5.5 900 10, 20, 30 and 45 01/29/2004
Entecavir Tablet II (Paddle) 50 Phosphate buffer pH 6.8 1000 10, 20, 30, and 45 06/21/2006
(50mM)
Enzalutamide Capsule II (Paddle) with 50 Tier 1 Medium: 0.3% cetyl 900 10, 15, 20, 30 and 05/28/2015
sinker trimethyl ammonium bromide 45
(CTAB) in 0.1 N HCl;Tier 2
Medium: 0.3% CTAB in 0.1 N
HCl containing Pepsin 600,000
USP units/L.
Eplerenone Tablet II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 12/19/2005
Eprosartan Mesylate Tablet II (Paddle) 75 0.2 M Phosphate Buffer, pH 7.5 1000 15, 30, 45 and 60 07/14/2008
Eprosartan Tablet II (Paddle) 75 0.2 M Phosphate Buffer, pH 7.5 1000 10, 20, 30 and 45 02/19/2008
Mesylate/Hydrochlorothiazide
Ergocalciferol Capsule II (Paddle) 100 0.5 N NaOH with 10% Triton- 500 15, 30, 45, 60 and 08/05/2010
X-100 90
Erlotinib HCl Tablet II (Paddle) 75 0.02% Tween 80 in 0.01 N HCl 1000 5, 10, 15, 20, 30 10/18/2018
and 45
Erythromycin Tablet Refer to USP 12/24/2015
Erythromycin Tablet (Delayed Refer to USP 10/31/2013

Release)
Erythromycin Ethylsuccinate Oral granule Develop a dissolution method 06/30/2016
Erythromycin Ethylsuccinate Suspension II (Paddle) 75 Monobasic Sodium Phosphate, 900 10, 20, 30, 45 and 01/27/2004
pH 6.8 Buffer with 1% SLS 60
Buffer w/ 1% SLS
Erythromycin Granules for Oral Develop a dissolution method 09/02/2010

Ethylsuccinate/Sulfisoxazole Acetyl Suspension
Escitalopram Oxalate Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30 and 45 02/20/2004
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Recommended
Sampling Times Date
Escitalopram Oxalate Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 10/06/2008
Eslicarbazepine Acetate Tablet II (Paddle) 100 Acetate Buffer, pH 4.5 1000 5, 10, 15, 20, 30 08/27/2015
and 45
Esomeprazole Magnesium Capsule (Delayed Refer to USP 08/27/2015

Release Pellets)
Esomeprazole Magnesium For Oral Suspension II (Paddle 100 Acid stage: 0.1 N HCl; Buffer Acid stage: 300; Acid stage: 120; 09/02/2010
(Delayed Release) stage: Sodium Phosphate Buffer stage: 1000 Buffer stage: 10, 20,
Buffer, pH 6.8 30, 45 and 60
Esomeprazole Magnesium Tablet (Delayed II (Paddle) 100 Acid stage: 0.1 N HCl; Buffer Acid stage: 300; Acid stage: 120; 10/20/2016
Release) stage: Phosphate Buffer, pH Buffer stage: 1000 Buffer stage: 10, 20,
6.8 30, 45 and 60
Estazolam Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/27/2004
Esterified Estrogens Tablet II (Paddle) 50 Water 900 15, 30, 45, 60, 90, 02/19/2008
120 and 180
Estradiol Vaginal Tablet I (Basket) 40 Phosphate Buffer, pH 4.75 ± 500 1, 2, 3, 5, 8, 10 and 07/21/2009
0.05 12 hours
Estradiol Vaginal Ring Incubator 130 0.9% Saline 250 1, 9, 16, 17, 18, 19, 01/03/2007
shaker 45 days
Estradiol (0.014 mg/24 hr) Film, Transdermal Develop a method to 10/28/2010

(Extended Release) characterize in vitro release
Estradiol (0.025 mg/24 hr, 0.0375 Film, Transdermal Develop a method to 10/28/2010
mg/24 hr, 0.05 mg/24 hr, 0.06 (Extended Release) characterize in vitro release
mg/24 hr, 0.075 mg/24 hr and 0.1
mg/24 hr)
Estradiol (Test 1) (0.025 mg/24 hr, Film, Transdermal VI 50 Water at 32 ± 0.5°C 0.025 mg/24 hr and 1, 2, 4, 6, 8, 10 and 10/28/2010
0.0375 mg/24 hr, 0.05 mg/24 hr, (Extended Release) (Cylinder) attach 0.0375 mg/24 hr: 12 hours
0.075 mg/24 hr and 0.1 mg/24 hr) the patch to a 500 mL; 0.05 mg/24
disk at the hr, 0.075 mg/24 hr
bottom of the and 0.1 mg/24 hr:
cylinder 900 mL
Estradiol (Test 2) (0.05 mg/24 hr Film, Transdermal V (Paddle over 50 Water at 32 ± 0.5°C 900 6, 12, 18, 24, 36, 10/28/2010
and 0.1 mg/24 hr) (Extended Release) Disk) with a 48, 60, 72 and 96
stainless steel hours
disk
Estradiol (Test 3) 0.0375 mg/24 hr, Film, Transdermal VI 50 Water at 32 ± 0.5°C 0.0375 mg/24 hr: 1, 2, 4, 6, 10, 12, 10/31/2013
0.05 mg/24 hr, 0.075 mg/24 hr and (Extended Release) (Cylinder) attach 500 mL; 0.05 mg/24 18, 24 and 36
0.1 mg/24 hr) the patch to the hr, 0.075 mg/24 hr hours
cylinder with and 0.1 mg/24 hr:
double-sided 900 mL
tape
Estradiol/Norethindrone Acetate Tablet Refer to USP 01/05/2012
Estradiol/Norgestimate Tablet II (Paddle) 50 0.3% SLS in water 500 10, 20, 30 and 45 07/09/2004
(1mg/0.09mg)
Estramustine Phosphate Sodium Capsule I (Basket) 100 Water 900 10, 20, 30 and 45 07/15/2009
Estrogens Conjugated Synthetic A Tablet I (Basket) 50 Water 900 1, 2, 3, 5, 8, 10 and 09/02/2010

12 hours
Estrogens, Conjugated Tablet II (Paddle) with 50 EC: 0.02 M Na Acetate Buffer 900 12/24/2015
(EC)/Medroxyprogesterone Acetate sinker (pH 4.5); MPA: 0.54% Sodium
(MPA) Lauryl Sulfate [SLS] in water
Estrogens, Conjugated Synthetic B Tablet II (Paddle) 50 Water 900 2, 5, 8 and 12 hours 10/06/2008
Eszopiclone Tablet II (Paddle) 50 0.1 N HCl 500 10, 20, 30 and 45 09/13/2007
23 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Ethacrynic Acid Tablet Refer to USP 12/23/2010
Ethambutol HCl Tablet Refer to USP 01/14/2008
Ethinyl Estradiol Tablet Refer to USP 09/22/2011
Ethinyl Estradiol/Ethynodiol Tablet II (Paddle) 75 0.25% Sodium Lauryl Sulfate 600 10, 20, 30 and 45 07/14/2008
Diacetate (SLS) in Water
Ethinyl Estradiol/Etonogestrel Vaginal Ring Develop a method to 01/31/2013

Ethinyl Estradiol/Levonorgestrel Tablet Refer to USP 02/19/2008

(AB)

(AB2)
Ethinyl Estradiol/Norethindrone Tablet Refer to USP 07/15/2009
Ethinyl Estradiol/Norethindrone Tablet (Chewable) II (Paddle) 75 0.09% Sodium Lauryl Sulfate in 500 10, 15, 20, 30 and 01/14/2008
0.1 N HCl 45
Ethinyl Estradiol/Norethindrone Tablet Refer to USP 07/15/2009

Acetate
Ethinyl Estradiol/Norethindrone Capsule II (Paddle) 100 Phosphate Buffer, pH 6.8, 900 5, 10, 20, 30, 45, 60 02/15/2018
Acetate containing 0.07% w/v Triton X and 75
100
Ethinyl Estradiol/Norethindrone Tablet (Chewable) II (Paddle) 75 0.025 M Na Acetate Buffer with 500 10, 15, 20, 30 and 12/24/2015
Acetate [0.01mg,0.01 mg;1 mg] 0.15% Sodium Lauryl Sulfate 45
[SLS] (pH 5.0) [degassed]
Ethinyl Estradiol/Norethindrone Tablet (Chewable) II (Paddle) 75 0.025 M Sodium Acetate Buffer 600 10, 15, 20, 30 and 02/14/2014
Acetate [0.02mg;1mg] with 0.15% SLS, pH 5.0 45
Ethinyl Estradiol/Norgestimate Tablet II (Paddle) 75 0.05% Tween 20 in water 600 5, 10, 20 and 30 01/14/2008
Ethinyl Estradiol/Norgestimate (AB) Tablet II (Paddle) 75 0.05% Tween 20 in water 600 10, 20, 30 and 45 01/14/2008
Ethinyl Estradiol/Norgestrel Tablet II (Paddle) 75 Water with 5 ppm of Tween 80 500 10, 20, 30, 45, 60 01/28/2004
and 90
Ethinyl Estradiol; Norelgestromin Film, Transdermal Modified USP 50 0.1% Hydroxypropyl-beta- 900 0.25, 0.5, 1, 2, 4, 8, 05/20/2009
Type V (Paddle- cyclodextrin at 32º C 12, 16, 20 and 24
over-disk) hours
Ethionamide Tablet I (Basket) 75 0.1 N HCl 900 10, 20, 30, 45 and 01/31/2013
60
Ethosuximide Capsule Refer to USP 04/15/2008
Etidronate Disodium Tablet Refer to USP 06/18/2007
Etodolac Tablet (Extended Refer to USP 06/24/2010

Release)
Etodolac Tablet Refer to USP 01/14/2008
Etoposide Capsule Refer to USP 06/24/2010
Etravirine (200 mg) Tablet II (Paddle) 70 1.0 % Sodium lauryl sulfate 1000 (phase 1): Phase 1: No 06/30/2011
(SLS) in 0.01 M HCl in two 1800 (phase 2) Sampling. Phase 2:
phases: Phase 1: 1000 mL of 5, 10, 20, 30, 45, 60
degassed 0.01 M HCl for 10 and 90
minutes. Phase 2: Add 800 mL
of 2.25% SLS in 0.01 M HCl.
24 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Etravirine (25 and 100 mg) Tablet II (Paddle) 50 1.0 % Sodium lauryl sulfate 500 (phase 1): 900 Phase 1: No 08/14/2014
(SLS) in 0.01 M HCl in two (phase 2) Sampling. Phase 2:
phases: Phase 1: 500 mL of 5, 10, 20, 30, 45, 60
degassed 0.01 M HCl for 10 and 90
minutes. Phase 2: Add 400 mL
of 2.25% SLS in 0.01 M HCl.
Everolimus Tablet II (Paddle) 50 Water with 0.4% sodium 500 10, 20, 30 and 45 07/01/2010
dodecylsulfate
Exemestane Tablet I (Basket) 100 0.5%(w/v) SLS Solution 900 10, 20, 30 and 45 08/17/2006
Ezetimibe Tablet II (Paddle) 50 0.45% SLS in 0.05 M Acetate 500 10, 20, 30 and 45 01/14/2008
Buffer, pH 4.5
Ezetimibe/Simvastatin Tablet II (Paddle) 50 0.01 M Sodium Phosphate, pH 900 5, 10, 20 and 30 01/03/2007
7.0/0.5% SDS
Ezogabine Tablet II (Paddle) 75 0.01 N HCl 1000 5, 10, 15, 20 and 30 08/15/2013
Famciclovir Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 04/09/2007
Famotidine Suspension II (Paddle) 25 and 50 0.1 M Phosphate buffer, pH 4.5 900 10, 15, 30 and 45 11/25/2008
Famotidine Tablet (Orally II (Paddle) 50 0.1 M Phosphate Buffer, pH 900 2, 5, 10, 15 and 20 10/06/2008
Disintegrating) 4.5
Famotidine Tablet (Chewable) II (Paddle) 50 0.1 M Phosphate Buffer, pH 4.5 900 10, 20, 30, 45 and 01/29/2004
60
Famotidine Tablet Refer to USP 06/18/2007
Famotidine/Calcium Tablet (Chewable) Develop a dissolution method 12/15/2009

Carbonate/Magnesium Hydroxide
Famotidine/Ibuprofen Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 5, 10, 15, 20, 30 08/15/2013
7.2 and 45
Febuxostat Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 900 5, 10, 15, 20 and 30 08/15/2013
6.0
Felbamate Suspension II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 01/28/2004
Felbamate Tablet Refer to USP 08/15/2013
Felodipine Tablet (Extended Refer to USP 01/14/2008

Release)
Fenofibrate Capsule (Micronized) II (Paddle) 75 0.025 M SLS in water 1000 10, 20, 30, 40 and 06/03/2008
60
Fenofibrate Capsule II (Paddle) 75 Phosphate Buffer w/ 2% Tween 900 15, 30, 45, 60, 90 02/19/2008
80 and 0.1% pancreatin, pH 6.8 and 120
Fenofibrate (40 mg and 120 mg) Tablet II (Paddle 75 0.75% Sodium lauryl sulfate in 900 5, 10, 20, 30, 45 10/21/2010
water and 60
Fenofibrate (48 mg and 145 mg) Tablet II (Paddle 50 25 mM Sodium lauryl sulfate in 1000 5, 10, 20, 30, 45 10/21/2010
water and 60
Fenofibrate (54 mg and 160 mg) Tablet II (Paddle 50 0.05 M Sodium lauryl sulfate in 1000 5, 10, 20, 30, 45 10/21/2010
water and 60
Fenofibric Acid Tablet II (Paddle) 75 Phosphate buffer, pH 6.8 900 5, 15, 30, 45 and 60 08/05/2010
Fenoprofen Calcium Capsule Refer to USP 11/25/2008
25 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Fentanyl Transdermal VII 30 cycles per Equimolar mixture of 0.005 M 250 mL for the 75 0.5, 1, 2, 4 and 24 06/09/2011
(Reciprocating minute. amplitude of phosphoric acid solution, and and 100 mcg/hr, 200 hours
holder)- about 2m. 0.005 M sodium phosphate, mL for the 50
cylinder. monobasic monohydrate (pH ~ mcg/hr and 150 mL
2.6). at 32° C. Change the test for the 25 and 12.5
samples into fresh pre- mcg/hr dosage
equilibrated release medium at strength.
the time points indicated.
Remove the protective liner and
place the film onto a piece of
nylon netting with adhesive
facing the net. Secure the
netting and transdermal system
using nylon tie wraps at the top
and bottom of the cylinder on
the holder. The adhesive side
faces towards the media.
Fentanyl Citrate Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH 6.8 500 1, 3, 5, 7, 10, 15 08/15/2013
and 20
Fentanyl Citrate Lozenges II (Paddle) 175 0.1 M Phosphate Buffer, pH 4.5 500 5, 10, 20, 30 and 40 05/20/2009
Fentanyl Citrate (0.1 mg and 0.4 Tablet (Buccal) II (Paddle) small 100 Phosphate Buffered Saline 100 3, 5, 7.5, 10, 15 and 11/20/2009
mg) volume solution, pH 7.0 20
dissolution
apparatus
Fentanyl Citrate (0.2 mg, 0.3 mg, Tablet (Buccal) II (Paddle) small 100 Phosphate Buffered Saline 200 3, 5, 7.5, 10, 15 and 11/20/2009
0.6 mg and 0.8 mg) volume solution, pH 7.0 20
dissolution
apparatus
Fentanyl Citrate (0.2 mg, 0.4 mg, Film (Buccal) I (Basket) 100 100 25-mM Phosphate Buffer, pH 60 5, 10, 15, 20, 30 12/15/2009
0.6 mg and 0.8 mg) mL dissolution 6.4 and 45
vessel
Fentanyl Citrate (1.2 mg) Film (Buccal) I (Basket) 100 100 25-mM Phosphate Buffer, pH 100 5, 10, 15, 20, 30 12/15/2009
mL dissolution 6.4 and 45
vessel
Ferric Citrate Tablet II (Paddle) 100 EDTA media ( 2.0 grams of 900 10, 20, 30, 45 and 08/27/2015
EDTA Na2 2H2O to 1000 mL of 60
purified water)
Ferrous Fumarate Tablet Refer to USP 03/17/2016
Fesoterodine Fumarate Tablet (Extended II (Paddle) with 75 Phosphate Buffer, pH 6.8 900 1, 2, 4, 6, 8, 10, 12, 08/15/2013
Release) sinker 16 and 20 hours
Fexofenadine HCl Tablet (Orally II (Paddle) 50 0.001 N HCl 500 5, 10, 15, 30 and 45 09/03/2008
Disintegrating)
Fexofenadine HCl Suspension II (Paddle) 50 0.001 N HCl 900 10, 20, 30 and 45 11/25/2008
Fexofenadine HCl Tablet II (Paddle) 50 0.001 N HCl 900 5, 10, 20, 30 and 45 02/19/2004
Fexofenadine HCl Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 01/29/2004
60
Fexofenadine Tablet (Extended Refer to USP 04/02/2009

HCl/Pseudoephedrine HCl Release)
Fidaxomicin Tablet II (Paddle) 75 Water with 2% Tween 80 900 10, 15, 30, 45 and 04/14/2016
60
Finafloxacin Otic Suspension Develop a method to 03/17/2016

Finasteride Tablet Refer to USP 07/25/2007
26 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Fingolimod Capsule I (Basket) 100 0.1 N HCl with 0.2% SDS 500 5, 10, 15, 20 and 30 08/15/2013
(sodium dodecyl sulfate)
Flavoxate HCl Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 20 and 30 01/29/2004
Flecainide Acetate Tablet Refer to USP 12/15/2009
Flibanserin Tablet II (Paddle) 50 Mcilvaine Buffer (Citric 900 5, 10, 15, 20 and 30 06/30/2016
Acid/Phosphate Buffer), pH 4.0
Fluconazole Tablet II (Paddle) 50 Water (deaerated) 900 (For 150, 200, 10, 20, 30, 45 and 03/04/2006
300 & 400 mg tabs) 60
500 (For 50 & 100
mg tabs)
Fluconazole (200 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/30/2004
Fluconazole (50 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 500 10, 20, 30 and 45 01/30/2004
Flucytosine Capsule Refer to USP 06/24/2010
Fludarabine Phosphate Tablet II (Paddle) 50 Water 900 5, 10, 15, 20 and 06/07/2012
30
Fludrocortisone Acetate Tablet Refer to USP 05/20/2009
Fluoxetine Capsules (Delayed Refer to USP 07/25/2007

Release)
Fluoxetine HCl Capsule Refer to USP 09/02/2010
Fluoxetine HCl Tablet Refer to USP 04/14/2016
Fluoxetine/Olanzapine Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 08/17/2006
Fluphenazine HCl Tablet Refer to USP 11/02/2017
Flutamide Capsule Refer to USP 01/31/2013
Fluvastatin Sodium Capsule Refer to USP 01/14/2008
Fluvastatin Sodium Tablet (Extended I (Basket) 50 Water (deaerated) 1000 0.5, 2, 4, 6 and 8 09/22/2011
Release) hours
Fluvoxamine Maleate Capsule (Extended II (Paddle) 50 Phosphate Buffer, pH 6.8 900 1, 2, 4, 6, 8 and 12 01/15/2010
Release) hours
Fluvoxamine Maleate Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/03/2007
Fosamprenavir Calcium Tablet II (Paddle) 75 250 mM Sodium Acetate/Acetic 900 10, 20, 30 and 45 12/16/2005
acid buffer pH 3.5
Fosamprenavir Calcium Oral Suspension II (Paddle) 25 10 mM HCl 900 5, 10,15 and 20 12/03/2007
Fosfomycin Tromethamine For Suspension Develop a dissolution method 07/20/2017
Fosinopril Sodium Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/30/2004
Fosinopril Tablet Refer to USP 08/11/2008

Sodium/Hydrochlorothiazide
Frovatriptan succinate Tablet II (Paddle) 50 Phosphate Buffer pH 5.5 900 5, 10, 15, 20 and 30 11/04/2008
Furosemide Tablet Refer to USP 08/05/2010
Gabapentin Tablet Refer to USP 06/03/2008
Gabapentin Capsule Refer to USP 06/03/2008
Gabapentin Enacarbil Tablet (Extended II (Paddle) 50 10 mM Phosphate buffer at pH 500 (for 300 mg); 0.5, 1, 2, 4, 6, 8, 12 01/31/2013
Release) 7.4 with 1.0 % SLS 900 (for 600 mg) and 24 hours
27 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Galantamine HBr Tablet Refer to USP 08/11/2008
Galantamine HBr Capsule (Extended II (Paddle) 50 50 mM potassium dihydrogen 900 1, 4, 10 and 12 01/20/2006
Release) phosphate buffer pH 6.5 hours
Comparative dissolution data
should also be provided in 900
ml pH 0.1 HCl, pH 4.5 buffer,
and water using Apparatus II
(Paddle) at 50 RPM.
Ganciclovir Capsule II (Paddle) 60 Water (deaerated) 900 10, 20, 30, 45 and 02/02/2004
60
Gefitinib Tablet II (Paddle) 50 Tween 80 (5% v/v) in water 1000 10, 20, 30, 45 and 10/28/2010
60
Gemfibrozil Tablet Refer to USP 07/25/2007
Gemifloxacin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30 and 45 01/03/2007
Glimepiride Tablet II (Paddle) 75 Phosphate Buffer, pH 7.8 900 5, 10, 15 and 30 07/23/2004
Glimepiride/Pioglitazone HCl Tablet II (Paddle) 75 For Pioglitazone: pH 2.0, HCl 900 For Pioglitazone: 04/02/2009
Buffer. For Glimepiride: pH 6.8, 10, 15, 20, 30 and
Sodium Phosphate Buffer with 45; For Glimepiride:
0.2% sodium dodecyl sulfate 10, 15, 20 and 30
Glimepiride/Rosiglitazone Maleate Tablet II (Paddle) 75 0.01 M HCl with 0.5% Sodium 900 5, 10, 15, 30, 45 01/03/2007
Dodecyl Sulfate and 60
Glipizide Tablet (Extended II (Paddle) 50 Simulated Intestinal Fluid 900 1, 2, 4, 8, 16 hours 04/10/2008
Release) without pancreatin, pH 7.5 and until at least
80% dissolved
Glipizide Tablet Refer to USP 08/05/2010
Glipizide/Metformin HCL Tablet Refer to USP 12/18/2008
Glyburide (Micronized) Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 10, 20, 30, 45 and 02/02/2004
7.5 60
Glyburide (Non-micronized) Tablet II (Paddle) 75 0.05 M Borate Buffer, pH 9.5 500 10, 20, 30, 45 and 02/02/2004
60
Glyburide/Metformin HCl Tablet Refer to USP 01/14/2008
Glycopyrrolate Tablet Refer to USP 07/25/2007
Goserelin Acetate Implant Prior to Swirl orbit of 50 mm Each implant should be 50 3, 14, 35, 56 and 84 11/04/2008
sampling, the jar at 205 rpm for 6 incubated in 50 mL of days (10.8 mg
is removed from seconds phosphate buffered saline, pH strength); 7, 14, 17,
incubation and 7.4, at 39°C (warmed overnight 21 and 28 days (3.6
mechanically before the implants are added), mg strength)
swirled with in a 120-mL Wheaton jar.
digital orbital
shaker
Granisetron Injectable (Extended Develop a method to 12/22/2016

Release) characterize in vitro release
Granisetron Film, Transdermal VI (Cylinder) 50 80 microL /L phosphoric acid 1000 2, 6, 12, 24, 36, 48, 03/03/2011
(Extended Release) (85%) at 32 ± 0.5°C 60, 72 and 96 hours
Granisetron HCl Tablet II (Paddle) 50 Phosphate buffer, pH 6.5 500 10, 20, 30, 45 and 06/05/2006
60
Griseofulvin Oral Suspension II (Paddle) 25 and 50 0.54% Sodium Lauryl Sulfate 1000 10, 20, 30 and 45 10/28/2010
(SLS) in Water
Griseofulvin (Microcrystalline) Oral Suspension II (Paddle) 25 and 50 0.54% Sodium Lauryl Sulfate 1000 10, 20, 30 and 45 10/28/2010
(SLS) in Water
28 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Griseofulvin (Microcrystalline) Tablet Refer to USP 01/15/2010
Griseofulvin (Ultramicrocrystalline) Tablet Refer to USP 11/04/2008
Guaifenesin Tablet (Extended I (Basket) 75 0.1 N HCl 900 1, 2, 4, 6 and 12 01/03/2007

Release) hours
Guaifenesin/Pseudoephedrine Tablet (Extended I (Basket) 50 0.01 N HCl 900 1, 2, 6, and 12 11/25/2008

Hydrochloride Release) hours
Guanfacine Tablet (Extended II (Paddle) 75 HCl Buffer, pH 2.2 900 1, 2, 4, 6, 8, 10, 12, 07/01/2010
Release) 16, 20 and 24 hours
Haloperidol Tablet Refer to USP 11/25/2008
Homatropine Tablet Refer to USP 10/30/2009

Methylbromide/Hydrocodone
Bitartrate
Hydralazine HCl Tablet Refer to USP 04/10/2008
Hydrochlorothiazide Capsule I (Basket) 100 0.1 N HCl 900 10, 20, 30 and 45 02/03/2004
Hydrochlorothiazide Tablet Refer to USP 07/25/2007
Hydrochlorothiazide/Irbesartan Tablet II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 09/24/2008
Hydrochlorothiazide/Lisinopril Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 02/03/2004
60
Hydrochlorothiazide/Losartan Tablet I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45 and 02/03/2004
Potassium 60
Hydrochlorothiazide/Metoprolol Tablet (Extended II (Paddle) Hydrochlorothiazide: Hydrochlorothiazide: 0.1N HCl; Hydrochlorothiazide: Hydrochlorothiazide: 10/31/2013
Succinate Release) 100; Metoprolol Metoprolol succinate: 500; Metoprolol 10, 15, 20, 30, and
succinate: 75 Phosphate Buffer, pH 6.8 succinate: 500 45 minutes;
Metoprolol
succinate: 1, 2, 4, 6,
8, 12, 16, 20 and 24
hours
Hydrochlorothiazide/Metoprolol Tablet Refer to USP 01/05/2012

Tartrate
Hydrochlorothiazide/Moexipril HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004
Hydrochlorothiazide/Olmesartan Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 5, 10, 15, 20, 30, 45 07/09/2007
Medoxomil 6.8 and 60
Hydrochlorothiazide/Quinapril HCl Tablet I (Basket) 100 Water (deaerated) 900 5, 10, 20 and 30 02/03/2004
Hydrochlorothiazide/Spironolactone Tablet Refer to USP 08/27/2009
Hydrochlorothiazide/Telmisartan Tablet Refer to USP 06/30/2016
Hydrochlorothiazide/Triamterene Tablet Refer to USP 07/31/2013
Hydrochlorothiazide/Valsartan Tablet Refer to USP 07/28/2016
Hydrochlorothizide/Triamterene Capsule Refer to USP 10/06/2008
Hydrocodone Bitartrate Tablet (Extended I (Basket-10 100 Simulated gastric fluid (SGF) 900 1, 2, 4, 8, 12, 16, 20 04/14/2016
Release) mesh) without enzyme (pH 1.2) and 24 hours
Hydrocodone Bitartrate Capsule (Extended I (Basket) 100 0.05 M Phosphate Buffer, pH 500 1, 2, 4, 6, 8, 10 and 05/28/2015
Release) 6.8 12 hours
Hydrocodone Bitartrate/Ibuprofen Tablet II (Paddle) 50 Phosphate Buffer, pH 7.2 900 5, 10, 15 and 30 02/04/2004
Hydrocortisone Tablet Refer to USP 05/09/2013
29 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Hydromorphone HCl Tablet (Extended VII 30 cycles per min Water 50 1, 2, 4, 6, 8, 10, 12, 05/26/2016
Release) (Reciprocating 16, 20 and 24
holder) (Sample hours
holder-Cage)
Hydromorphone HCl Tablet Refer to USP 07/25/2007
Hydroxyurea Capsule Refer to USP 09/03/2008
Hydroxyzine HCl Tablet Refer to USP 07/25/2007
Hydroxyzine Pamoate Capsule Refer to USP 04/02/2009
Hydroxyzine Pamoate Suspension Develop a dissolution method 04/02/2009
Ibandronate Sodium Tablet II (Paddle) 50 Water 500 5, 10, 15, 30 and 45 01/03/2007
Ibrutinib Capsule II (Paddle) 75 3.0% w/v Polysorbate 20 in 50 900 5, 10, 20, 30 and 45 06/25/2015
mM Phosphate Buffer, pH 6.8
Ibuprofen Tablet (Chewable) II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 10, 20, 30 and 45 02/04/2004
7.2
Ibuprofen Suspension Refer to USP 11/04/2008
Ibuprofen Suspension/Drop II (Paddle) 50 Phosphate Buffer, pH 7.2 900 5, 10, 15 and 20 11/04/2008
Ibuprofen Capsule (Soft- I (Basket) 150 50mM Phosphate Buffer, pH 900 5, 10, 20, 30 and 45 05/09/2013
Gelatin/Liquid Fill) 7.2
Ibuprofen Tablet Refer to USP 07/25/2007
Ibuprofen Potassium Capsule (Soft- I (Basket) 150 Phosphate Buffer, pH 7.2 900 5, 10, 20 and 30 02/04/2004
Gelatin/Liquid Fill)
Ibuprofen Sodium Capsule I (Basket) 150 Phosphate Buffer, pH 7.2 900 5, 10, 15, 20 and 30 06/25/2015
Ibuprofen/Diphenhydramine Capsule I (Basket) 100 Phosphate Buffer (200 mM), 900 10, 20, 30 and 45 01/03/2007
pH7.2
Ibuprofen/Oxycodone HCl Tablet I (Basket) 100 Phosphate buffer, pH 7.2 500 10, 20, 30 and 45 04/09/2007
Ibuprofen/Phenylephrine HCl Tablet II (Paddle) 50 50 mM Potassium Phosphate 900 10, 15, 20, 30 and 01/05/2012
Buffer, pH 6.5, (degassed) 45
Ibuprofen/Pseudoephedrine HCl Capsule I (Basket) 150 Tier 1: 0.05 M phosphate buffer, 900 10, 20, 30 and 45 03/04/2006
pH 7.2 Tier 2: 0.05 M
phosphate buffer, pH 7.2 with
NMT 1750 USP protease
units/L of 1 X USP pancreatin
Ibuprofen/Pseudoephedrine HCl Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 5, 10, 15 and 30 02/04/2004
7.2
Icosapent Ethyl Capsule Develop an in vitro release 08/15/2013

method using USP IV (Flow-
Through Cell), and, if
applicable, Apparatus II
(Paddle) or any other
appropriate pharmacopoeial
apparatus, for comparative
evaluation by the Agency.
Idelalisib Tablet II (Paddle) 75 0.01 N HCl 750 5, 10, 15, 20 and 30 08/27/2015
Iloperidone Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 30, 45 08/05/2010
and 60
Imatinib Mesylate Tablet II (Paddle) 50 0.1 N HCl 1000 5, 10, 15, 20 and 30 09/22/2011
Imipramine HCl Tablet Refer to USP 01/14/2008
30 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Imipramine Pamoate Capsule I (Basket) 100 0.1 N HCl without pepsin and 900 30, 60, 90, 120, 150 01/14/2008
with 0.3% pepsin (addition of and 180
pepsin is recommended only
when significant slow
dissolution is observed)
Indapamide Tablet Refer to USP 04/15/2008
Indinavir Sulfate Capsule II (Paddle) 50 0.1 M Citrate Buffer, pH 3.8 900 10, 15, 20 and 30 02/04/2004
Indomethacin Capsule (Extended Refer to USP 07/25/2007

Release)
Indomethacin (40 mg and 20 mg) Capsule I (Basket) 100 10 mM citric acid buffer, pH 750 5, 10, 15, 20 and 30 05/28/2015
5.75
Indomethacin (50 and 25 mg) Capsule Refer to USP 05/28/2015
Irbesartan Tablet Refer to USP 08/11/2008
Isavuconazonium Sulfate Capsule II (Paddle) with 75 Diluted McIlvaine Buffer [12.5 900 10, 20, 30, 45, 60, 03/17/2016
sinker mM disodium hydrogen 75 and 90
phosphate solution +6.25 mM
citric acid solution ] + 0.5 %
Sodium Lauryl sulfate (SLS)
Isocarboxazid Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 02/04/2004
60
Isoniazid Tablet Refer to USP 04/15/2008
Isosorbide Dinitrate Capsule (Extended Refer to USP 06/25/2015

Release)
Isosorbide Dinitrate Tablet (Extended Refer to USP 06/25/2015

Release)
Isosorbide Dinitrate Tablet Refer to USP 06/25/2015
Isosorbide Dinitrate/Hydralazine Tablet I (Basket) 100 0.05 N HCl 900 10, 15, 20, 25, 30 06/10/2009
HCl and 45
Isosorbide Mononitrate Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/04/2004
Isosorbide Mononitrate Tablet (Extended Refer to USP 11/25/2008

Release)
Isotretinoin Capsule I (Basket, with 100 0.05 M Potassium Phosphate 900 15, 30, 45, 60 and 10/06/2008
20 mesh) Buffer, dibasic, pH 7.8, 90
containing 0.5% solid LDAO
Isradipine Capsule II (Paddle) 50 0.1% Lauryl Dimethylamine 500 10, 20, 30, 45 and 02/25/2004
Oxide (LDAO) in water 60
Isradipine (10 mg) Tablet (Extended II (Paddle) 50 0.2% Lauryl Dimethylamine 1000 2, 4, 8, 12, 16 and 02/25/2004
Release) Oxide (LDAO) in water 24 hours
Isradipine (5 mg) Tablet (Extended II (Paddle) 50 0.2% Lauryl Dimethylamine 500 2, 4, 8, 12, 16 and 02/25/2004
Release) Oxide (LDAO) in water 24 hours
Itraconazole Capsule II (Paddle) 100 SGF without Enzyme 900 10, 20, 30, 45, 60 02/04/2004
and 90
Itraconazole Tablet II (Paddle) 75 0.1 N HCl 900 5, 15, 30, 45, 60, 75 08/15/2013
and 90
Ivabradine HCl Tablet Develop a dissolution method 05/18/2017
Ivacaftor Tablet II (Paddle) with 65 50 mM Sodium Phosphate 900 5, 10, 15, 20 and 30 06/25/2015
sinker Buffer with 0.7% Sodium
Dodecyl Sulfate (SDS), pH 6.8
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Recommended
Sampling Times Date
Ivacaftor/lumacaftor Tablet Lumacaftor: II Lumacaftor:65; Lumacaftor: 0.5% (w/v) CTAB Lumacaftor: 900; 5, 10, 15, 20 and 30 03/17/2016
(Paddle); Ivacaftor: 65 in 50 mM Sodium Acetate Ivacaftor: 900
Ivacaftor: II Trihydrate buffer (pH 4.5);
(Paddle) Ivacaftor: 0.4% (w/v) SLS in 50
mM Sodium Phosphate buffer
(pH 6.8)
Ivacaftor/Tezacaftor [FDC: IVA+ Tablet/Tablet II (Paddle) with FDC: IVA: FDC: IVA: 50 mM Sodium FDC: IVA: 900/ TEZ: 5, 10, 15, 20, 30 03/07/2019
TEZ]; Ivacaftor [IVA] (Copackage) option to use a 65/TEZ:75; IVA: 65 Phosphate Buffer with 0.4% 900; IVA: 900 and 45
sinker Sodium Dodecyl Sulfate (SDS),
pH 6.8/TEZ: 0.2 SDS% in 0.1 N
HCl; IVA: 50 mM Sodium
Phosphate Buffer with 0.7%
SDS, pH 6.8;
Ivermectin Tablet II (Paddle) 50 0.5% SDS in 0.01 M Monobasic 900 10, 20, 30, 45 and 02/04/2004
Sodium Phosphate, pH 7.0 60
Ixazomib Citrate Capsule I (Basket) 100 0.1 N HCl 500 5, 10, 15, 20 and 30 10/20/2016
Ketoconazole Tablet I (Basket) 100 Simulated gastric fluid w/o 800 15, 30, 45, 60 and 01/03/2007
pepsin 90
Ketoprofen Tablet II (Paddle) 50 SIF Buffer without enzyme, pH 900 10, 20, 30, 45 and 02/05/2004
7.4 60
Ketoprofen Capsule II (Paddle) 50 0.05 M Phosphate Buffer pH 1000 10, 20, 30 and 45 07/25/2007
7.4
Ketorolac Tromethamine Tablet Refer to USP 04/15/2008
Labetalol HCl Tablet Refer to USP 08/27/2009
Lacosamide Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 06/07/2012
45
Lamivudine Tablet Refer to USP 02/07/2019
Lamivudine 150 mg/Zidovudine Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15, 20, 30 01/03/2007
300mg Tablets and Abacavir and 40
Sulfate 300 mg Tablets-co-
packaged
Lamivudine/Raltegravir Ka Tablet II (Paddle) 75 Water 900 10, 15, 20, 30 and 10/20/2016
45
Lamivudine/Stavudine/Nevirapine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, 45 and 01/03/2007
60
Lamivudine/Zidovudine Tablet Refer to USP 11/02/2017
Lamivudine/Zidovudine + Efavirenz Tablet (Copackage) II (Paddle) Lamivudine and Lamivudine and Zidovudine: Lamivudine and 10, 20, 30, and 45 01/03/2007
Zidovudine: 75 0.1 N HCl Efavirenz: 2% SLS in Zidovudine: 1000
Efavirenz: 50 water Efavirenz: 900
Lamivudine/Zidovudine + Tablet (Copackage) II (Paddle) 50 Lamivudine and Zidovudine: 900 10, 15, 30, 45 and 01/03/2007
Nevirapine water Nevirapine: 0.06 M HCl 60
(pH 1.2)
Lamivudine/Zidovudine/ Nevirapine Tablet II (Paddle) 50 0.01 N HCl 900 10, 15, 30, 45 and 01/03/2007
60
Lamotrigine Tablet (Regular) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Lamotrigine Tablet (Chewable II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 01/14/2008
dispersible)
Lamotrigine Tablet (Extended Refer to USP 02/18/2016

Release)
Lansoprazole Capsule (Delayed Refer to USP 11/04/2008

Release)
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Recommended
Sampling Times Date
Lansoprazole Tablet (Delayed II (Paddle) 75 Acid Stage: 0.1 N HCl; Buffer 500 (Acid), 900 60 (Acid), 10, 20, 30 11/04/2008
Release, Orally Stage: Phosphate Buffer, pH (Buffer) and 45 (Buffer)
Disintegrating) 6.8 with 5 mM Sodium Dodecyl
Sulfate
Lanthanum Carbonate Chewable Tablet Reciprocating 10 dpm (dip rate per 0.25 N HCl 900 (modified from 10, 20, 30 and 45 01/03/2007
Cylinder minute) the standard
(Apparatus 3 apparatus 3 vessel
modified) to achieve sink
condition)
Lapatinib Ditosylate Tablet II (Paddle) 55 2% Polysorbate 80 in 0.1 N HCl 900 10, 15, 30 and 45 10/30/2009
Ledipasvir/Sofosbuvir Tablet II (Paddle) 75 1.5% Polysorbate 80 in 10 mM 900 5, 10, 15, 20, 30, 45 08/27/2015
Potassium Phosphate Buffer and 60
with 0.0075 mg/mL Butylated
Hydroxytoluene (BHT), pH 6.0
Leflunomide Tablet II (Paddle) 100 Water (deaerated) 1000 10, 20, 30 and 45 02/05/2004
Leflunomide (100 mg) Tablet II (Paddle) 100 Water (deaerated) + 0.6% 1000 10, 20, 30 and 45 05/31/2007
Polyoxyethylene Lauryl Ether
Lenalidomide Capsule II (Paddle) 50 0.01 N HCl 900 10, 15, 20, 30 and 04/15/2008
45
Lenvatinib Mesylate Capsule II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/17/2016
Lesinurad Tablet II (Paddle) 75 pH 4.5 sodium acetate buffer 900 10, 20, 30 and 45 03/17/2016
with 1% SLS
Letermovir Tablet II (Paddle) 75 25 mM Na Acetate Buffer, pH 900 10, 15, 20, 30, 45 02/08/2018
4.5 with 0.6% Tween-80 and 60
Letrozole Tablet Refer to USP 04/10/2008
Letrozole (LET); Ribociclib Tablet/Tablet II (Paddle) RIB: 50; LET: 75 RIB: 0.01 N HCl; LET: 0.1 N RIB: 900; LET: 900 5, 10, 15, 20, 30 03/07/2019
Succinate (RIB) (Copackage) HCl and 45
Leucovorin Calcium Tablet Refer to USP 07/14/2008
Leuprolide Acetate Injectable (Extended Develop a dissolution method 01/15/2010

Release) using USP IV (Flow-Through
Agency
Levetiracetam Tablet, for Suspension II (Paddle) 50 Phosphate Buffer, pH 6.8 900 2.5, 5, 10, 15 and 03/02/2017
(degas) 20
Levetiracetam Tablet (Extended I (Basket) 100 0.05 M Phosphate Buffer, pH 900 1, 2, 4, 6, 8 and 12 04/02/2009
Release) 6.0 hours
Levetiracetam Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/05/2004
Levocarnitine Tablet Refer to USP 900 08/27/2015
Levocetirizine Dihydrochloride Tablet II (Paddle) 50 Water 900 10, 20, 30 and 45 08/11/2008
Levofloxacin Tablet Refer to USP 07/28/2016
Levomilnacipran HCl Capsule (Extended II (Paddle) 75 Water (deaerated) 1000 1, 2, 4, 6, 8, 12, 16, 05/28/2015
Release) 20 and 24 hours
Levonorgestrel Tablet II (Paddle) 75 0.1 N HCl with 0.1% SLS 1000 10, 20, 30, 45, 60 02/05/2004
and 90
Levonorgestrel Intrauterine Device Develop a method to 02/14/2014

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Recommended
Sampling Times Date
Levothyroxine Sodium Tablet Refer to USP 07/25/2007
Lidocaine Topical Patch Paddle over 50 Acetic acid/sodium acetate 500 10, 20, 30, 60, 120 01/03/2007
Disk (Apparatus buffer, pH 4.0 at 32ºC and 180
5)
Linaclotide Capsule I (Basket) 50 50 mM Phosphate Buffer, pH 500 5, 10, 15, 20 and 30 12/24/2015
4.5
Linagliptin Tablet I (Basket) 50 0.1 N HCl 900 5, 10, 15, 20, 30 08/15/2013
and 45
Linagliptin/Metformin HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30 05/15/2014
and 45
Linagliptin/Metformin HCl Tablet (Extended I (Basket) 100 Simulated Gastric Fluid (SGF) 900 Linagliptin 10, 15, 07/28/2016
Release) without enzyme (pH 1.2) 20, 30 and 45
(degassed) minutes; Metformin:
1, 2, 4, 6, 8 and 12
hours
Linezolid Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 5, 10, 20, 30 and 45 01/14/2008
6.8
Linezolid Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 10, 20, 30 and 45 01/14/2008
6.8
Liothyronine Sodium Tablet Refer to USP 06/18/2007
Lisdexamfetamine Dimesylate Capsule II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 20 10/06/2008
Lisinopril Tablet Refer to USP 01/14/2008
Lithium Carbonate Tablet (Extended Refer to USP 01/14/2008

Release)
Lithium Carbonate Tablet Refer to USP 04/10/2008
Lithium Carbonate Capsule Refer to USP 07/25/2007
Lomefloxacin HCl Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30 and 45 02/05/2004
Lomitapide Mesylate Capsule II (Paddle) 50 0.001 N HCl with 0.1% 500 mL (5 mg 5, 10, 20, 30 and 45 06/25/2015
Polysorbate 80 strength); 1000 mL
(10 and 20 mg
strength)
Lomustine Capsule Develop a dissolution method 12/24/2015
Loperamide HCl Capsule Refer to USP 06/25/2015
Loperamide HCl Tablet Refer to USP (provide 06/25/2015

individual unit data).
Loperamide HCl Oral Suspension II (Paddle) 25 0.01 N HCl 900 10, 20, 30, 45, 60, 06/25/2015
75 and 90
Loperamide HCl Tablet (Chewable) II (Paddle) 50 0.2 M Acetate Buffer, pH 4.7 500 5, 10, 15, 20 and 30 06/25/2015
Loperamide HCl/Simethicone Tablet II (Paddle) 75 0.1N HCl 500 10, 15, 20, 30 and 08/27/2015
45
Lopinavir/Ritonavir Capsule (Soft-Gelatin) II (Paddle) 50 Tier 1: 0.05 M Polyoxyethylene 900 10, 15, 30 and 45 06/18/2007
10 Lauryl Ether with 10 mM
Sodium Phosphate monobasic
(pH 6.8); Tier II: same as above
with NMT 1750 USP units/L of
Pancreatin
Lopinavir/Ritonavir Tablet (Combination) Refer to USP 01/15/2015
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Recommended
Sampling Times Date
Loratadine Capsule (Soft-Gelatin) II (Paddle) with 75 Tier I: 0.1N HCl with 0.1% 900 10, 20, 30, 45 and 02/28/2013
sinker Tween 20. Tier II: 0.1N HCl with 60
0.1% Tween 20 with addition of
pepsin (as per USP).
Loratadine Tablet (Orally I (Basket) 50 SGF without enzyme 900 2, 4, 6 and 10 07/14/2008
Disintegrating)
Loratadine Tablet (Chewable) II (paddle) 50 0.1 N HCl 500 15, 30, 45 and 60 07/14/2008
Loratadine/Pseudoephedrine Tablet (Extended I (Basket) 75 900 mL 0.1 N HCl for one hour, 900 Loratadine:10, 15, 08/05/2010
Sulfate (10 mg /240 mg) Release) then replace the medium with 20, 30 and 45;
900 mL 0.05 M phosphate Pseudoephedrine:
buffer at pH6.8 containing 1, 2, 4, 8, 12, 16, 18
0.01% sodium lauryl sulfate. and 24 hours
Loratadine/Pseudoephedrine Tablet (Extended II (Paddle) 50 900 mL 0.1 N HCl for one hour, 900 Loratadine:15, 20, 08/05/2010
Sulfate (5 mg /120 mg) Release) then replace with 900 mL 0.05 30, 45, 60 and 90;
M phosphate buffer at pH 8.2 Pseudoephedrine:
containing 0.01% sodium lauryl 1, 2, 4, 8, 12 and 16
sulfate hours
Lorazepam Tablet Refer to USP 01/14/2008
Lorcaserin HCl Tablet II (Paddle) 50 0.1 N HCl (deaerated) 900 5, 10, 15, 20 and 12/22/2016
30
Lorcaserin HCl Tablet (Extended I (Basket) 100 0.1 N HCl (deaerated) 900 1, 2, 4, 5, 8 12, 16 10/20/2016
Losartan Potassium Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 02/06/2004
Losartan Potassium Tablet Refer to USP 01/05/2012
Loteprednol Etabonate Ophthalmic Develop a method to 06/30/2016

Loteprednol Etabonate/Tobramycin Ophthalmic Develop a method to 01/31/2013

Lovastatin Tablet (Extended II (Paddle) 50 0.5% sodium lauryl sulfate 900 1, 2, 4, 6, 8, 12, 16 02/07/2019
Release) (SLS) / sodium phosphate and 20 hours
buffer (0.01M), pH 6.5
Lovastatin/Niacin Tablet (Extended I (Basket) 100 For Niacin: Water; for 900 For Niacin: 0.5, 1, 2, 01/14/2008
Release) Lovastatin: 0.05 M phosphate 3, 6, 9, 12, 20 and
buffer, pH 7.0 with 0.5% sodium 24 hours; For
dodecyl sulfate Lovastatin: 15, 30,
45 and 60 min
Lubiprostone Capsule (Soft-Gelatin) II (Paddle) 50 0.1 N HCl/1% HCO-40 900 15, 30, 45, 60, 90 08/19/2010
(Polyoxyl 40 hydrogenated and 120
castor oil)
Lurasidone HCl Tablet II (Paddle) 50 McIlvaine buffer, pH 3.8 [(0.025 900 5, 10, 15, 20 and 01/31/2013
M Citric acid Solution + 0.05M 30
Na2HPO4 solution
(3:2)] Measure the pH and
adjust to 3.8, if necessary.
Degas before use.
Macitentan Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8 with 900 10, 15, 20, 30 and 05/28/2015
0.1% of Cetrimonium bromide 45
(CTAB)
Magnesium Hydroxide/Omeprazole Tablet (Chewable) II (Paddle) 150 0.029 M sodium phosphate 900 15, 30, 45, and 60 02/19/2008
/Sodium Bicarbonate buffer w/ 0.5% SDS, pH 7.4
Magnesium Hydroxide/Omeprazole Tablet (Chewable) II (Paddle) 150 pH 7.4 Phosphate Buffer with 900 15, 30, 45, 60 and 10/06/2008
/Sodium Bicarbonate 0.5% SDS 90
35 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Maraviroc Tablet I (Basket) 100 0.01 N HCl 900 10, 15, 20, 30 and 10/21/2010
45
Mebendazole Tablet (Chewable) II (Paddle) 75 0.1 N HCl containing 1% 900 15, 30, 45, 60, 90 10/06/2008
Sodium Lauryl Sulfate and 120
Mebendazole ( 500 mg) Tablet (Chewable) II (Paddle) 75 1% Sodium Lauryl Sulfate 900 5, 10, 15, 30, 45 12/22/2016
(SLS) in 0.01 N HCl and 60 minutes
Mecamylamine HCl Tablet Refer to USP 02/15/2018
Meclizine HCl Tablet (Chewable) I (Basket) 100 0.01 N HCl 900 10, 20, 30, 45 and 04/08/2010
60
Meclizine HCl Tablet I (Basket) 100 0.01 N HCl 900 10, 20, 30, 45 and 08/27/2009
60
Medroxyprogesterone Acetate Injectable Suspension Test 1: IV (Flow Test 1: 17 mL/min; Test 1: 0.5 % SDS in water ; Test 1:use Open Test 1: 5, 10, 15, 20, 10/31/2013
through cell), Test 2: 50 rpm Test 2: 0.35 % SDS in water Mode: Test 2: 900 30, 40, 50, 60, 70,
22.6 mm cell, 13 (provide data with both tests) mL 80 and 90; Test 2: 5,
g of 1 mm 10, 15, 30, 60, 90,
beads; Test 2: II 120, 240, 360, 1440
(Paddle) and 2880
Medroxyprogesterone Acetate Tablet Refer to USP 12/24/2015
Medroxyprogesterone Acetate Injectable Suspension Develop a method to 02/08/2018

(104mg/0.65ml) characterize in vitro release
Mefenamic Acid Capsule Refer to USP 12/15/2009
Mefloquine HCl Tablet I (Basket) 100 SGF without enzyme 900 10, 20, 30, 45 and 02/06/2004
60
Megestrol Acetate Oral Suspension Refer to USP 12/15/2009
Meloxicam Capsule I (Basket) 100 Phosphate Buffer, pH 6.1 with 500 mL (for 5 mg); 5, 10, 15, 20 and 30 06/30/2016
0.1% Sodium Lauryl Sulfate 1000 mL (for 10 mg)
(SLS)
Meloxicam Suspension II (Paddle) 25 Phosphate buffer at pH 7.5 900 5, 10, 15 and 30 01/26/2006
Meloxicam Tablet II (Paddle) 75 Phosphate Buffer, pH 7.5 900 10, 20, 30, 45 and 02/20/2004
60
Melphalan Tablet Refer to USP 07/14/2008
Memantine HCl Tablet I (Basket) 100 0.1 N HCl with NaCl (12 g NaCl 900 10, 20, 30 and 45 12/16/2005
in 6 L water adjust pH to 1.2
with HCl)
Memantine HCl Capsule (Extended I (Basket) 100 pH 1.2 NaCl/HCl Buffer (degas) 900 1, 2, 3, 4, 6, 8, 10 03/02/2017
Menthol/Methyl Salicylate Topical Patch VI (Cylinder) 50 Neutralized phthalate buffered 900 10, 20, 30, 60, 120, 01/31/2013
solution (0.2 M potassium 150 and 180
biphthalate) with pH of 5.0 at 32
± 0.5°C
Meprobamate Tablet Refer to USP 11/25/2008
Mercaptopurine Tablet II (Paddle) 50 0.1 N HCl 900 20, 30, 45, 60, 90 02/06/2004
and 120
Mercaptopurine Oral Suspension II (Paddle) 50 0.1N HCl 900 5, 10, 15, 20 and 30 12/24/2015
Mesalamine Suppository II (Paddle) with 75 (for 500 mg) & For 500 mg strength: 0.2 M 900 30, 60, 90, 120 and 01/30/2006
option to use a 125 (for 1000 mg) Phosphate buffer, pH 7.5 at 37 150
sinker deg. C For 1000 mg strength:
0.2 M Phosphate buffer, pH 7.5
at 40 deg. C
36 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Mesalamine Capsule (Delayed II (Paddle) Phase 1 & 2: 100 Phase 1: 0.1N HCl (degas); Phase 1: 500; Phase 1: 120; 06/30/2016
Release) rpm; Phase 3: 50 Phase 2: pH 6.0 Buffer (degas); Phase 2: 900; Phase 2: 60; Phase
rpm Phase 3: pH 7.2 Buffer Phase 3: 900 3: 20, 30, 45, 60,
75, 90 and 120
Mesalamine (1.2 gram) Tablet (Delayed II (Paddle) 100 Acid stage (A): 100 mM HCl Acid stage (A): 750 Acid stage (A): 2 06/10/2009
Release) Buffer stage (B): Phosphate mL; Buffer stage hours; Buffer stage
Buffer, pH 6.4 Buffer stage (C): (B): 950 mL; Buffer (B): 1 hour; Buffer
Phosphate Buffer, pH 7.2 stage (C): 960 mL stage (C): 1, 2, 4, 6
and 8 hours
Mesalamine (250 mg and 500 mg) Capsule (Extended Refer to USP 06/10/2009
Release)
Mesalamine (375 mg) Capsule (Extended I (Basket) 100 Acid Stage: 0.1N HCl Buffer Acid stage: 750 mL; Acid stage: 2 hours; 06/10/2009
Release) stage: Phosphate Buffer, pH Buffer stage: 1000 Buffer stage: 0.5, 1,
6.8 mL 2, 4, 7 and 9 hours
Mesalamine (400 mg and 800 mg) Tablet (Delayed Refer to USP 11/05/2010
Release)
Mesalamine Enema Rectal Enema II (Paddle) 50 Phosphate Buffer, pH 7.2 900 5, 10, 15, and 30 06/18/2007
Mesna Tablet II (Paddle) 50 0.06 N HCl 500 5, 10, 15, 20 and 30 02/09/2004
Mestranol/Norethindrone Tablet Refer to USP 03/25/2010
Metaxalone Tablet Refer to USP 10/20/2016
Metformin HCl Tablet (Extended Refer to USP 12/12/2008

Release)
Metformin HCl Tablet Refer to USP 04/10/2008
Metformin HCl/Pioglitazone HCl Tablet II (Paddle) 50 pH 2.5 McIlvaine buffer (0.1 M 900 10, 20, 30 and 45 01/03/2007
Citric acid adjusted to pH 2.5
with 0.2 M Na2HPO4)
Metformin HCl/Saxagliptin Tablet (Extended I (Basket) 100 Phosphate Buffer, pH 6.8 1000 Metformin: 1, 2, 3, 01/26/2012
Release) 4, 6, 8, 10 and 12
hours. Saxagliptin:
5, 10, 15, 20 and 30
minutes
Metformin HCl/Sitagliptin Tablet II (Paddle) 75 0.025 M NaCl 900 10, 15, 20 and 30 10/06/2008
Phosphate
Metformin/Repaglinide Tablet II (Paddle) 50 Citric acid/phosphate buffer, pH 900 5, 10, 15, 20 and 30 10/30/2009
5.0
Methadone HCl Tablet Refer to USP 07/14/2008
Methazolamide Tablet II (Paddle) 100 pH 4.5 Acetate Buffer 900 10, 15, 20, 30 and 05/28/2015
45
Methenamine Hippurate Tablet Refer to USP 07/31/2013
Methimazole Tablet Refer to USP 01/14/2008
Methocarbamol Tablet Refer to USP 08/15/2013
Methotrexate Sodium Tablet Refer to USP 04/02/2009
Methoxsalen Capsule Refer to USP 03/25/2010
Methscopolamine Bromide Tablet Refer to USP 02/15/2018
Methylergonovine Maleate Tablet Refer to USP 03/17/2016
Methylnaltrexone Bromide Tablet II (Paddle) 50 0.1 N HCl 1000 5, 10, 15, 20 and 30 10/20/2016
37 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Methylphenidate Tablet (Extended Refer to USP 02/14/2014

Release)
Methylphenidate Tablet (Extended II (Paddle) 75 Acid Stage: 0.1 N HCl; Buffer Acid Stage: 900 mL; Acid Stage: 15, 30, 11/16/2017
Release, Orally Stage: Phosphate Buffer, pH Buffer Stage: 1000 60, 120 minutes;
Disintegrating ) 6.8 mL Buffer Stage: 1, 2,
3, 4, 6 and 8 hours
Methylphenidate Capsule (Extended II (Paddle) 50 Water 500 1, 2, 4, 6, 8, 12 04/15/2008

Release) hours and until at
least 80% released
Methylphenidate Transdermal Patch VI (Cylinder) 50 0.01 N HCl at 32ºC 900 0.5, 1.5, 3, 4 hours 04/15/2008
and until at least
80% released
Methylphenidate (BX) Capsule (Extended I (Basket) 75 0-2 hrs:0.01 N HCl. 2-10 hrs: 0-2 hrs: 500. 2-10 0.5, 1, 3, 6, 8 and 07/25/2007
Release) Phosphate Buffer, pH 6.8. hrs:500 10 hours
Methylphenidate HCl Tablet Refer to USP (provide

Methylphenidate HCl Tablet (Chewable) I (Basket) 100 Water 900 15, 30, 45 and 60 03/25/2010
Methylphenidate HCl Tablet (Extended II (Paddle) 75 0.4M KH2PO4 solution (degas) 900 0.25, 0.5, 1, 2, 3, 4, 03/17/2016
Release, Chewable) 6, 8 hours
Methylphenidate HCl Powder for Suspension II (Paddle) 75 0.4 M Phosphate Buffer, pH 4.5 900 0.25, 0.5, 1, 2, 3, 4, 06/02/2016
(Extended Release) 6 and 8 hours
Methylphenidate HCl Capsule (Extended I (Basket) 100 Acid Stage:(First 2 hours) 0.01 Acid: 500 mL; 0.5, 1, 2, 4, 6, and 10/20/2016
Release) N HCl; Buffer Stage (2-10 Buffer: 500 mL 10 hours
hours): Phosphate Buffer, pH
6.0
Methylprednisolone Tablet Refer to USP 01/29/2010
Methylprednisolone Acetate Injectable Suspension IV (Flow- 0.55 % SDS 15, 30, 45, 60, 90 10/08/2009
Through Cell- and 120
Open system)
Methyltestosterone Capsule Refer to USP 07/31/2013
Methyltestosterone Tablet II (Paddle) 50 Water 900 10, 20, 30, 45, 60 07/31/2013
and 75
Metoclopramide HCl Tablet Refer to USP 07/15/2009
Metoclopramide HCl Tablet (Orally I (Basket) 50 Water 900 5, 10, 15, 20, 30 04/08/2010
Disintegrating) and 45
Metolazone Tablet II (Paddle) 75 2% SLS in 0.05 M Sodium 900 30, 60, 90, 120 and 02/10/2004
Phosphate Buffer, pH 7.5 150
Metoprolol Succinate Tablet (Extended Refer to USP 07/25/2007

Release)
Metoprolol Tartrate Tablet Refer to USP 07/25/2007
Metronidazole Capsule I (Basket) 100 0.1 N HCl 900 10, 20, 30 and 45 02/09/2004
Metronidazole Tablet Refer to USP 08/05/2010
Metronidazole Capsule Refer to USP 12/24/2015
Metyrosine Capsule Refer to USP 02/15/2018
Miconazole Tablet (Buccal) I (Basket) 60 0.5% SDS (Sodium 1000 1, 2, 4, 6, 8, 10 and 10/28/2010
dodecylsulfate) in water-pH 12 hours
adjusted to 6.5 ± 0.5
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Recommended
Sampling Times Date
Miconazole Nitrate Suppository (Vaginal) I (Basket) 100 0.45% SLS in water 900 15, 30, 45 and 60 10/08/2009
Midodrine HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/06/2004
Midostaurin Capsule II (Paddle) 50 Tier 1:Deionized water with 900 5, 10, 15, 20, 30 11/02/2017
0.5% Polysorbate 20; Tier 2: and 45
Deionized water with 0.5%
Polysorbate 20 containing
pepsin
Mifepristone Tablet II (Paddle) 75 0.01 N HCl 900 5, 10, 15, 20 and 30 01/14/2008
Mifepristone [300 mg] Tablet II (Paddle) 50 pH 1.8 KCl Buffer 900 10, 15, 20, 30 and 03/17/2016
45
Miglitol Tablet II (Paddle) 75 Water 900 10, 20, 30, and 45 03/03/2011
Miglustat Capsule I (Basket) 100 0.1 N HCl 1000 10, 20, 30 and 45 01/03/2007
Milnacipran HCl Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 30, 45 and 08/05/2010
60
Miltefosine Capsule II (Paddle) 50 0.1 N HCl 750 5, 10, 15, 20 and 30 03/17/2016
Minocycline HCl Capsule (Extended I (Basket- 10 100 0.1 N HCl 900 0.25, 0.5, 1.0, 1.5, 06/02/2016
Release) mesh) 2, 3 and 4 hours
Minocycline HCl ER Tablets I (Basket) 100 0.1 N HCl 900 1, 2, 4, 6 hours and 01/14/2008
until 80% of drug
released
Minocycline HCl Capsule Refer to USP 04/15/2008
Minocycline HCl Tablet Refer to USP 07/25/2007
Minocycline HCl (135 mg and 105 Tablet (Extended I (Basket) 100 pH 2.1 Buffer (Degassed) 900 15, 30, 45, 60, 90, 11/02/2017
mg) Release) 120, 180 and 210
Minoxidil Tablet Refer to USP 04/15/2008
Mirabegron Tablet (Extended I (Basket) 100 Phosphate Buffer, pH 6.8 900 1, 3, 5, 7, 8.5, 10 05/09/2013
Mirtazapine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004
Mirtazapine Tablet (Orally II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Disintegrating (ODT))
Misoprostol Tablet II (Paddle) 50 Water (deaerated) 500 5, 10, 20 and 30 02/10/2004
Mitotane Tablet Refer to USP 06/10/2009
Modafinil Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 02/10/2004
60
Moexipril HCl Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/10/2004
Molindone HCl Tablet Refer to USP 07/25/2007
Montelukast Granule I (Basket) (100 50 0.5% w/v SDS in Water 900 5, 15, 20 and 30 09/24/2008
mesh)
Montelukast Sodium Tablet (Chewable) II (Paddle) 50 0.5% SDS in water 900 5, 10, 20 and 30 03/04/2006
Montelukast Sodium Tablet II (Paddle) 50 0.5% SDS in water 900 5, 10, 20 and 30 04/09/2007
Morphine Sulfate Tablet II (Paddle) 50 Deionized Water 900 5, 15, 20 and 30 01/15/2010
Morphine Sulfate Tablet (Extended I (Basket) 100 Simulated Gastric Fluid [SGF] 900 0.25, 0.5, 1, 1.5, 2, 10/20/2016
Release) without enzyme 4, 6 and 8 hours
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Recommended
Sampling Times Date
Morphine Sulfate Capsule (Extended Refer to USP 08/11/2008

Release)
Morphine Sulfate (AB) Tablet (Extended I (Basket) 50 Water (deaerated) 900 1, 2, 3, 6, 9 and 12 12/23/2010
Release) hours
Morphine Sulfate (AB2) Capsule (Extended II (Paddle) 50 Phosphate Buffer, pH 6.8 900 1, 2, 3, 4, 6, 8, 10, 08/14/2014
Release) 12, 16, 20, 24 hours
Morphine Sulfate (BC) Tablet (Extended I (Basket) 100 Water 500 1, 2, 4, 6, 8, 10 and 12/23/2010
Release) 12 hours
Morphine Sulfate/Naltrexone HCl Capsule (Extended II (Paddle) 50 Acid stage: 0.1 N HCl; Buffer Acid stage: 500; Morphine Sulfate: 01/26/2012
Release) stage: 0.05 Phosphate Buffer, Buffer stage: 500 Acid stage: 1 hour;
pH 7.5 Buffer stage: 1, 3, 5,
8 and 10 hours.
Naltrexone HCl:
Acid stage: 1 hour;
Buffer stage: 1, 12,
24, 48, 73 and 96
hours.
Moxifloxacin Tablet II (Paddle) 50 0.1 N HCl 900 15, 30, 45 and 60 06/18/2007
Mycophenolate Mofetil Suspension II (Paddle) 40 0.1 N HCl 900 5, 10, 20 and 30 02/10/2004
Mycophenolate Mofetil Capsule II (Paddle) 40 0.1 N HCl 900 5, 10, 20 and 30 02/10/2004
Mycophenolate Mofetil Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004
Mycophenolic acid Tablet (Delayed II (Paddle) 50 Acid Stage: 0.1 N HCl; Buffer 750 (Acid), 1000 120 (Acid), 10, 20, 12/19/2008
Release) Stage: Buffer Solution, pH 6.8 (Buffer) 30, 45 and 60
(After initial 120 mins., 250 mL (Buffer)
of 0.2 M sodium phosphate
solution is added to acid stage
medium. The pH of the mixture
is adjusted to 6.8 using 0.2 M
sodium phosphate, 2 N sodium
hydroxide, or concentrated HCl
acid solution if necessary.)
Nabilone Capsule II (Paddle) 50 0.1% Tween 80 solution 1000 15, 30, 45 and 60 07/14/2008
Nabumetone Tablet Refer to USP 07/25/2007
Nadolol Tablet Refer to USP 04/02/2009
Naldemedine Tablet II (Paddle) 50 Mixture of pH 6.8 phosphate 500 5, 10, 15, 20 and 30 11/02/2017
buffer [25 mM disodium
hydrogen phosphate] solution
and water (1:1)
Naloxegol Oxalate Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 05/28/2015
Naltrexone Injectable Suspension Phosphate buffered saline with 09/01/2011

0.02% Tween 20 and 0.02%
Sodium azide, pH 7.4 (final
osmolality should be 270 ± 20
mOsm), or any other
appropriate medium, at 37°C.
Develop an in vitro release
appropriate method, for
Agency
Naltrexone HCl Tablet Refer to USP 04/15/2008
40 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Naltrexone HCl / Oxycodone HCl Capsule (Extended Develop a dissolution method 12/22/2016
Release)
Naltrexone HCl/Bupropion HCl Tablet (Extended II (Paddle) 50 Water (degassed) 900 0.5, 1, 1.5, 2, 3, 4, 6 09/03/2015
Naproxen Suspension Develop a dissolution method 11/16/2017
Naproxen Tablet (Delayed Refer to USP 12/15/2009

Release)
Naproxen Tablet Refer to USP 07/25/2007
Naproxen Sodium Tablet (Extended II (Paddle) 50 Phosphate Buffer, pH 7.5 900 0.5, 1, 2, 3, 4, 6, 8, 04/08/2010
Release) 10, 12 and 14 hours
Naproxen Sodium Capsule II (Paddle) 75 Sodium Phosphate Buffer, pH 900 10, 15, 20, 30 and 05/28/2015
7.4 ± 0.05 45
Naproxen Sodium Tablet Refer to USP 10/04/2012
Naproxen Tablet II (Paddle) 75 0.1M Sodium Phosphate buffer, 900 5, 10, 15, 20 and 30 06/25/2015
Sodium/Diphenhydramine HCl pH 7.4 (deaerated)
Naproxen Tablet II (Paddle) 75 0.1M Sodium Phosphate Buffer, 900 5, 10, 15, 20, 30 05/28/2015
Sodium/Diphenhydramine HCl pH 7.4 and 45
Naproxen Sodium/Sumatriptan Tablet I (Basket) 75 Phosphate Buffer, pH 6.8 900 10, 15, 20, 30 and 07/01/2010
Succinate 45
Naproxen/Esomeprazole Tablet (Delayed II (Paddle) with Naproxen::50 rpm Naproxen:: Acid Stage: 0.1M Naproxen::Acid Naproxen:: Acid 06/06/2013
Magnesium Release) sinkers Esomeprazole::75 HCl; Buffer Stage: 0.05M Stage: 1000; Buffer stage: 120; Buffer
rpm Phosphate buffer, pH 6.8. Stage: 1000; stage: 10, 20, 30,
Sampling for Acid stage: Esomeprazole::900 45, 60, 75 and 90;
Transfer the un-dissolved tablet Esomeprazole::10,
& sinker to the vessel 20, 30, 45, 60, 75
containing the buffer stage and 90
medium. Add, 10 mL of 10 M
NaOH to each vessel of the
remaining acid stage medium.
Continue rotation at 100 rpm for
30 minutes, withdraw aliquot
and analyze. Esomeprazole
(second set of tablets)(without
pre-exposure to acid stage)::
0.05M Phosphate buffer, pH 7.4
Naratriptan HCl Tablet Refer to USP 07/25/2007
Nateglinide Tablet II (Paddle) 50 0.01 N HCl with 0.5% (w/v) SLS 1000 10, 20, 30 and 45 01/03/2007
Nebivolol HCl Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30 and 45 01/15/2010
Nebivolol/Valsartan Tablet I (Basket) 100 67 mM Phosphate Buffer pH 900 5, 10, 15, 20 and 30 10/20/2016
6.8 with 0.5% SDS
Nefazodone HCl Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 01/03/2007
60
Nelfinavir Mesylate Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30, 01/03/2007
45, 60 and 90
Nelfinavir Mesylate Powder for Suspension II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30, 09/13/2007
and 45
Neomycin Sulfate Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900 15, 30, 45 and 60 01/14/2008
6.8
Nepafenac Ophthalmic Develop a method to 08/14/2014

41 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Netupitant/Palonosetron HCl Capsule II (Paddle) Netupitant:100; Netupitant: 0.07M Phosphate Netupitant: 900; Netupitant: 10, 20, 09/03/2015
Palonosetron: 75 buffer pH 6.8 containing 1% Palonosetron: 500 30, 45, 60 and 75;
sodium SDS ; Palonosetron: Palonosetron: 5, 10,
0.01 N HCl 15, 20, 30 and 45
Nevirapine Tablet (Extended I (Basket) 75 0.04 M Sodium phosphate 900 1, 2, 3, 4, 5, 6, 8, 01/31/2013

Release) buffer pH 6.8 containing 2% 10, 12, 16 and 20
sodium lauryl sulfate hours
Nevirapine Suspension II (Paddle) 25 0.1 N HCl 900 10, 20, 30, 45 and 02/11/2004
60
Nevirapine Tablet Refer to USP 09/13/2007
Niacin Tablet (Extended I (Basket) 100 Water 900 1, 3, 6, 9, 12, 15, 20 06/10/2009
Niacin/Simvastatin Tablet (Extended Niacin: I (40 100 Niacin: Water; Simvastatin: 0.5 900 Niacin: 1, 3, 6, 9, 01/15/2010
Release) mesh rotating % SDS in 0.01 M Sodium 12, 15, 18, 20 and
Basket); Phosphate, pH 7.0 24 hours;
Simvastain: I Simvastatin: 10, 20,
(10 mesh 30, 45 and 60
rotating Basket)
Nicardipine HCl Capsule (Extended II (Paddle) 50 0.1 N HCl 1000 0.5 , 2 and 6 hours 07/14/2008
Release)
Nicardipine HCl Capsule II (Paddle) 50 0.033 M Citric Acid Buffer, pH 900 10, 20, 30 and 45 02/11/2004
4.5
Nicotine Film, Transdermal Refer to USP 01/31/2013

(Extended Release)
Nicotine Polacrilex Chewing Gum Chewing 60 cycles (chews) Phosphate Buffer, pH 7.4 or or 20 5, 10, 20 and 30 01/05/2012
Machine as per minute any other appropriate buffer
desribed in and conditions
European
Pharmacopoeia
(2.9.25)
Nicotine Polacrilex Lozenge (Mini) III 20 dpm Phosphate buffer pH 7.4 250 15, 30, 45, 60 and 03/09/2017
(Reciprocating 90
Cylinder)
Nicotine Polacrilex Lozenge I (Basket) 100 Phosphate Buffer, pH 7.4 900 0.5, 1, 2, 3, 6 and 8 12/23/2010
hours
Nifedipine Capsule Refer to USP 03/03/2011
Nifedipine Tablet (Extended Refer to USP 07/25/2007

Release)
Nilotinib Hydrochloride Capsule I (Basket) 100 0.1 N HCl 1000 10, 15, 30 and 45 10/30/2009
Monohydrate
Nilutamide Tablet Develop a dissolution method 05/20/2009
Nimodipine Capsule II (Paddle) 50 0.5% SDS in water 900 10, 20, 30, and 45 04/09/2007
Nintedanib Esylate Capsule II (Paddle) with 100 0.1 N HCl 900 10, 15, 20, 30, 45 09/03/2015
sinker and 60
Niraparib Capsule II (Paddle) with 50 Tier 1: 0.08M Sodium Acetate 900 10, 15, 20, 30, 45 11/02/2017
sinker Buffer, pH 4.0; Tier 2: 0.08M and 60
Sodium Acetate Buffer, pH 4.0
containing pepsin (750,000
units/L)
42 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Nisoldipine Tablet (Extended II (Paddle) with 50 HCl with SLS (32.5 ± 0.1 g 900 1, 4, 8, 12, 15, 18 04/02/2009
Release) option to use a Sodium Lauryl Sulfate in 6489 and 24 hours
sinker mL of purified water containing
17.0 mL HCl, pH adjusted to
1.20 ± 0.05 with HCl)
Nitazoxanide Oral Suspension II (Paddle 100 Phosphate buffer at pH 7.5 with 900 10, 20, 30, 45 and 10/21/2010
6% hexadecyltrimethyl 60
ammonium bromide, bath
temperature at 25ºC
Nitazoxanide Tablet II (Paddle) 75 Phosphate buffer at pH 7.5 with 900 10, 20, 30, 45, 60 01/03/2007
6% hexadecyltrimethyl
ammonium bromide, bath
temperature at 25ºC
Nitisinone Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 2 mg tablets: 500 10, 15, 20, 30, 45, 02/15/2018
mL; 5 mg and 10 60, 75 and 90
mg tablets: 900 mL
Nitisinone Capsule II (Paddle) with 50 Phosphate Buffer, pH 6.8 1000 5, 10, 15, 20, 30 11/02/2017
sinker and 45
Nitisinone Suspension II (Paddle) 50 pH 1.2 HCl Buffer (degassed) 1000 10, 15, 20, 30 and 12/22/2016
45
Nitrofurantoin Capsule Refer to USP 04/02/2009
Nitrofurantoin Suspension II (Paddle) 50 Phosphate Buffer, pH 7.2 900 15, 30, 60, 120 and 04/02/2009
180
Nitroglycerin Film, Modified USP 100 Deionized Water at 32º C 900 10, 20, 30, 45, 60, 04/08/2010
Transdermal (Extended Type V (Paddle- 90, 120 and 180
Release) over-disk)
Nitroglycerin Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH 6.5 500 1, 3, 5, 8, and 10 01/15/2010
Nizatidine Capsule Refer to USP 01/14/2008
Norethindrone Tablet Refer to USP 10/08/2009
Norethindrone Acetate Tablet Refer to USP 08/27/2009
Nortriptyline HCl Capsule Refer to USP 09/03/2015
Nystatin Oral Suspension II (Paddle) 25, 50 and 75 0.1 % and 0.2% SLS in water 900 5, 10, 20, 30, 45 10/28/2010
and 60
Nystatin Tablet II (Paddle) 75 Water with 0.1% SLS 900 15, 30, 45, 60 and 01/03/2007
90
Obeticholic Acid Tablet II (Paddle) 75 0.08% polysorbate 80 in 50mM 900 5, 10, 15, 20, 30 11/02/2017
sodium phosphate dibasic and 45
buffer, pH 6.8
Octreotide Injection Injectable (Extended Develop a dissolution method 12/23/2010

Release) using USP IV (Flow-Through
Agency
Ofloxacin Tablet I (Basket) 100 0.1 N HCl 900 10, 20, 30 and 45 02/12/2004
Olanzapine Tablet Refer to USP 01/15/2015
Olanzapine Tablet (Orally Refer to USP 01/15/2015

Disintegrating)
43 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Olanzapine Pamoate For Intramuscular IV (Flow through Flow @ 3 mL/min 1% SLS in pH 6.8 Phosphate use Open Mode 10, 20, 30, 45, 60, 12/24/2015
Suspension (Extended cell), 22.6 mm Buffer 75, 90, 105, 120,
Release) cell 150, 180, 240, 360,
480, 600, and 720
Olaparib Capsule II (Paddle) 100 1% Polysorbate 80 in Water 1000 10, 20, 30, 45 and 06/02/2016
60
Olmesartan Medoxomil Tablet Refer to USP 11/02/2017
Olsalazine Sodium Capsule I (Basket) 100 Phosphate Buffer, pH 7.5 900 10, 20, 30 and 45 02/12/2004
Ombitasvir/ Paritaprevir/ Ritonavir Tablet II (Paddle) 75 Ombitasvir, paritaprevir, 900 Ombitasvir, 08/27/2015
and Dasabuvir Sodium ritonavir: 0.05 M sodium paritaprevir,
phosphate buffer, pH 6.8 with ritonavir: 10, 20, 30,
0.3% polyoxyethylene 10 lauryl 45, 60, 90, 120 and
ether; Dasabuvir sodium: 0.05 150; Dasabuvir: 5,
M Sodium Phosphate buffer, 10, 15, 20 and 30
pH 6.8 with 15 mM cetyl
triethylammonium bromide
(CTAB)
Ombitasvir/Paritaprevir/Ritonavir Tablet II (Paddle) with 75 0.05M Sodium Phosphate 900 10, 20, 30, 45, 60, 06/30/2016
sinker Buffer, pH 6.8 with 0.3% (w/v) 90, 120, 150 and
Polyoxyethylene 10 Lauryl 180
Ether (POE10LE)
Omega-3-Acid Ethyl Esters Capsule Develop an in vitro release 03/17/2016

appropriate pharmacopoeial
apparatus, for comparative
evaluation by the Agency.
Omeprazole OTC Tablet (Delayed II (Paddle) 100 Tablets are pre-exposed to 750 Acid stage: 750; Acid stage: 120; 02/28/2013
Release) ml of 0.1M HCL for 2 hrs and Buffer stage: 1000 Buffer stage: 10, 20,
then 250 ml of 0.2M Na3PO4 is 30, 45 and 60
added to the medium to give
1000 ml with pH 6.8
Omeprazole Capsule (Delayed Refer to USP 06/18/2007

Release)
Omeprazole (Orally Disintegrating) OTC Tablet (Delayed II (Paddle) 100 Tablets are pre-exposed to 500 Acid stage: 500; Acid stage: 120; 02/08/2018
Release) ml of 0.1M HCL for 2 hrs and Buffer stage: 900 Buffer stage: 10, 20,
then 400 ml of 0.235M 30, 45 and 60
Na2HP04 is added to the
medium. Adjust if necessary
with 2 N HCI or 2 N NaOH to a
pH of 6.8
Omeprazole Magnesium For suspension II (Paddle) 100 Pre-exposed to 300 mL of 0.1M Acid stage: 300; Acid stage: 120; 02/07/2019
(Delayed Release) HCl for 2 hrs and then 700 mL Buffer stage: 1000 Buffer stage: 10, 20,
of 0.086 M Na2HPO4 is added 30, 45 and 60
to the medium to give 1000 mL
with pH 6.8
Omeprazole Magnesium OTC Tablet (Delayed II (Paddle) 100 Tablets are pre-exposed to 300 300 ml for the acid Sampling started at 01/03/2007
Release) mL of 0.1M HCL for 2 hrs and stage; 1000 ml for the buffer stage 10,
then 700 mL of 0.086 M the buffer stage 20, 30, 45 and 60
Na2HPO4 is added to the
medium containing the capsule
to give 1000 mL with pH 6.8
Omeprazole Sodium Bicarbonate Powder for suspension II (Paddle) 50 0.25 mM Sodium Phosphate 900 5, 10, 15, and 30 06/20/2007
(Immediate Release) Buffer, pH 7.4
Omeprazole Sodium Bicarbonate Capsule II (Paddle) 75 Phosphate Buffer, pH 7.4 900 15, 30, 45 and 60 07/14/2008
44 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Ondansetron Tablet (Orally Refer to USP 06/18/2007

Disintegrating)
Ondansetron Film (Oral) V (Paddle over 50 0.1 N HCl 900 5, 10, 15, 20 and 30 01/26/2012
Disk) with a
stainless steel
disk (120 mesh
screens)
Ondansetron HCl Tablet II (Paddle) 50 Water (deaerated) 500 5, 10, 15 and 30 02/12/2004
Orlistat Capsule II (Paddle) 75 3% SLS in 0.5% Sodium 900 10, 20, 30, 45 and 02/12/2004
Chloride, pH 6.0 60
Orphenadrine Citrate Tablet (Extended Refer to USP 08/27/2009

Release)
Oseltamivir Phosphate Oral Suspension II (Paddle) 25 0.1 N HCl 900 5, 10, 15, 20 and 30 07/15/2009
Oseltamivir Phosphate Capsule II (Paddle) 50 0.1 N HCl 900 5, 10, 20, and 30 01/03/2007
Osimertinib Mesylate Tablet II (Paddle) 50 0.2 % NaCl solution in water 900 10, 15, 20, 30 and 10/20/2016
[adjust to pH 1.3] 45
Ospemifene Tablet II (Paddle) 50 2% Sodium Dodecyl Sulfate 900 10, 20, 30, 45, 60 06/02/2016
(SDS) in Water and 75
Oxaprozin Tablet Refer to USP 03/17/2016
Oxcarbazepine Tablet (Extended II (Paddle) with 75 1.0% SDS in Deionized Water 900 1, 2, 4, 6, 8 and 10 08/15/2013
Release) sinker (degassed) hours
Oxcarbazepine Suspension II (Paddle) 75 1% SDS in water 900 10, 20, 30 and 45 02/12/2004
Oxcarbazepine (150 mg) Tablet II (Paddle) 60 0.3% SDS in water 900 10, 20, 30, 45, 60 02/12/2004
and 90
Oxcarbazepine (300 mg) Tablet II (Paddle) 60 0.6% SDS in water 900 10, 20, 30, 45, 60 02/12/2004
and 90
Oxcarbazepine (600 mg) Tablet II (Paddle) 60 1% SDS in water 900 10, 20, 30, 45, 60 02/12/2004
and 90
Oxybutynin Trans-dermal Paddle over 50 Phosphate Buffer, pH 4.5 @ 900 1, 4, 24 hours 01/03/2007
Disk (Apparatus 32oC
5)
Oxybutynin Chloride Tablet (Extended Refer to USP 12/24/2015

Release)
Oxycodone Capsule (Extended I (Basket) 100 22 mM Sodium Acetate buffer, 900 1, 2, 4, 6, 8, 12, 16, 07/28/2016
Release) pH 4.5 with 0.03% Tween 20 20 and 24 hours
Oxycodone HCl Capsule II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 05/28/2015
Oxycodone HCl Tablet Refer to USP 01/14/2008
Oxycodone HCl Tablet (Extended Refer to USP 03/17/2016

Release)
Oxycodone HCl/ Naloxone HCl Tablet (Extended II (Paddle) 50 Simulated Gastric Fluid [SGF, 900 0.25, 0.5, 1, 2, 4, 6, 12/22/2016
Release) pH 1.2] without enzyme 8, 10 and 12 hours
Oxymorphone HCl Tablets II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/14/2008
Oxymorphone HCl Tablet (Extended II (Paddle) with 50 45 mM Phosphate Buffer, pH 900 1, 2, 4, 6, 8 and 10 02/14/2014
Release) sinker 4.5 hours
Palbociclib Capsule II (Paddle) with 50 0.1 N HCl 900 10, 15, 20, 30 and 03/17/2016
sinker 45
45 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Paliperidone Tablet (Extended II (Paddle) 50 Modified SGF, pH 1.0 [NaCl 500 1, 2, 4, 6, 8, 12, 14, 08/27/2009
Release) (0.2% w/w) in 0.0825N HCl] 18 and 24 hours
Paliperidone Palmitate Intramuscular II (Paddle) 50 0.489% (w/v) Polysorbate 20 in 900 1.5, 5, 8, 10, 15, 20, 09/01/2011
Suspension (Extended 0.001 N HCl @25.0 °C. 30 and 45
Release)
Paliperidone Palmitate [3-month Intramuscular II (Paddle) 50 0.489% (w/v) Polysorbate 20 in 900 5, 30, 60, 90, 120, 03/17/2016
injection] Suspension (Extended 0.001 N HCl @25.0 °C. 180, 240, 300 and
Release) 360
Palonosetron HCl Capsule II (Paddle) 75 0.1 N HCl 500 10, 15, 30, 45 and 08/05/2010
60
Pancrelipase Capsule (Delayed Refer to USP 03/17/2016

Release)
Pancrelipase Tablet II (Paddle) 50 Phosphate Buffer, pH 4.5 900 10, 20, 30, 45 and 06/02/2016
60
Panobinostat Lactate Capsule I (Basket) 100 0.01 N HCl 900 5, 10, 15, 20 and 30 10/20/2016
Pantoprazole Sodium Delayed Release II (Paddle) 100 Acid Stage: 0.1 N Hydrochloric Acid stage: 750; Acid stage: 60, 90 10/30/2009
Granules for Oral Acid; Buffer Stage: 0.05 M Buffer stage: 1000 and 120; Buffer
Suspension Tribasic Sodium Phosphate stage: 10, 20, 30, 45
(Add 250 mL of 0.2 mM and 60
Tribasic Sodium Phosphate
after completion of acid stage);
pH 6.8 (Method B)
Pantoprazole Sodium Tablet (Delayed Refer to USP 07/21/2009

Release)
Paricalcitol Capsule I (Basket) 100 4 mg/mL (0.4%) 500 20, 30, 45, 60 06/18/2007
Lauryldimethylamine N-oxide
(LDAO)
Paromomycin Sulfate Capsule I (Basket) 50 0.05 M Phosphate Buffer, pH 900 5, 10, 15, 20, 30 02/13/2004
6.8 and 45
Paroxetine Tablet (Extended Refer to USP 11/19/2015

Release)
Paroxetine HCl Suspension II (Paddle) 100 SGF without enzyme 900 10, 20, 30 and 45 02/13/2004
Paroxetine HCl Tablet Refer to USP 01/14/2008
Paroxetine Mesylate Tablet II (Paddle) 60 Simulated Gastric Fluid (SGF) 900 5, 10, 15, 20, 30 03/07/2019
without enzymes and 45
Paroxetine Mesylate Capsule II (Paddle) with 75 Simulated Gastric Fluid without 900 5, 10, 15, 20 and 30 02/14/2014
wire sinker enzyme , pH 1.2+0.05
Pazopanib HCl Tablet II (Paddle) 75 50 mM Sodium Acetate buffer, 900 10, 15, 30, 45 and 08/05/2010
pH 4.5, containing 0.75% SDS 60
Pemoline Tablet II (Paddle) 75 Water (deaerated) 900 10, 20, 30, 45, 60 02/13/2004
and 90
Penbutolol Sulfate Tablet Refer to USP 06/24/2010
Penicillamine Capsule Refer to USP 09/03/2008
Penicillin V Tablet Refer to USP 06/09/2011
Penicillin V Potassium Tablet Refer to USP 06/09/2011
Pentosan Polysulfate Sodium Capsule I (Basket) 50 Water 900 5, 15, 30, 45 and 60 04/15/2008
Pentoxifylline Tablet (Extended Refer to USP 06/09/2011

Release)
46 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Perampanel Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 05/15/2014
Perampanel Suspension II (Paddle) 50 0.1 N HCl 900 [890 mL 0.1 N 5, 10, 15, 20 and 30 12/22/2016
HCl + 10 mL
perampanel
suspension]
Pergolide Mesylate Tablet II (Paddle) 50 Simulated gastric fluid TS with 500 10, 20, 30 and 45 03/04/2006
cysteine without enzymes
Perindopril Erbumine Tablet II (Paddle) 50 0.1 N HCl 900 10, 20 , 30 and 45 06/20/2007
Perphenazine Tablet Refer to USP 12/15/2009
Phendimetrazine Tartrate Tablet Refer to USP 05/20/2009
Phendimetrazine Tartrate Capsule Refer to USP 06/10/2009
Phendimetrazine Tartrate Capsule (Extended II (Paddle) 50 1 hour - SGF w/o Enzymes; 900 1, 2, 4, 6 and 8 06/10/2009
Release) after 1 hour - SIF w/o Enzymes hours
Phenelzine Sulfate Tablet II (Paddle) 50 Simulated Gastric Fluid without 900 10, 20, 30 and 45 03/25/2010
enzymes, pH 1.2
Phenoxybenzamine HCl Capsule Refer to USP 04/10/2008
Phentermine HCl Tablet II (Paddle) 50 Water 900 10, 20, 30, 45 and 08/27/2009
60
Phentermine HCl Capsule Refer to USP (provide 12/24/2015

Phentermine HCl Tablet Refer to USP 07/15/2009
Phentermine HCl Tablet (Orally II (Paddle) 50 Water 500 mL (15 mg) or 5, 10, 15, 20 and 07/31/2013
Disintegrating) 900 mL (30 mg and 30
37.5 mg)
Phentermine HCl/Topiramate Capsule (Extended I (Basket) 100 Water (deionized and 750 Phentermine: 10, 06/06/2013
Release) degassed) 15, 20, 30 and 45;
Topiramate: 0.5, 1,
2, 3, 4, 6 and 8
hours
Phenytoin Suspension Refer to USP 06/18/2007
Phenytoin Tablet (Chewable) Refer to USP 01/14/2008
Phenytoin Sodium Capsule Refer to USP 06/18/2007
Phytonadione Tablet Develop a dissolution method 03/25/2010
Pilocarpine HCl Tablet II (Paddle) 50 0.1 N HCl 500 10, 20, 30, 45 and 01/20/2004
60
Pimavanserin Tartrate Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 15, 20 and 30 07/28/2016
Pimozide Tablet Refer to USP 02/19/2008
Pindolol Tablet Refer to USP (provide 12/24/2015

Pioglitazone HCl Tablet II (Paddle) 75 HCl-0.3 M KCl Buffer, pH 2.0 900 5, 10, 15 and 30 02/13/2004
Pirfenidone Tablet II (Paddle) 50 Water 1000 5, 10, 15, 20, 30 03/27/2018

and 45
Pirfenidone Capsule II (Paddle) with 50 Water (Deionized) 1000 5, 10, 15, 20, 30 09/03/2015
sinker and 45
Piroxicam Capsule Refer to USP 10/04/2012
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Recommended
Sampling Times Date
Pitavastatin Calcium Tablet I (Basket) 35 0.05 M Phosphate Buffer, pH 900 5, 10, 15, 20, 30 12/23/2010
6.8 and 45
Pomalidomide Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 05/28/2015
45
Ponatinib HCl Tablet I (Basket) 50 pH 2.1, KCl/HCl buffer 900 10, 15, 20, 30, 45 09/03/2015
(degassed) and 60
Posaconazole Tablet (Delayed II (Paddle) 75 Acid Stage: 0.01 N HCl: Buffer Acid Stage: 750 mL; Acid Stage: 120; 06/25/2015
Release) Stage: 50 mM phosphate Buffer Stage 1000 Buffer Stage: 10,
buffer, pH 6.8 with 0.37 % mL 15, 20, 30 and 45
Polysorbate 80 (after 120
minutes, to the acid stage, add
250 mL of 0.2M Phosphate
Buffer, 1.46% Polysorbate 80)
Posaconazole Oral Suspension II (Paddle) 25 0.3% SLS 900 10, 20, 30 and 45 12/03/2007
Potassium Chloride Tablet (Extended Refer to USP 07/25/2007

Release)
Potassium Chloride Capsule (Extended Refer to USP 12/24/2015

Release)
Potassium Citrate Tablet Refer to USP 08/05/2010
Pramipexole Dihydrochloride Tablet (Extended I (Basket) 100 0.05 M phosphate buffer, pH 500 1, 2, 4, 6, 9, 12, 16, 09/02/2010
Release) 6.8 20 and 24 hours
Pramipexole Dihydrochloride Tablet II (Paddle) 50 0.023 M Citrate/0.155 M 500 5, 10, 15, 30 and 45 10/09/2007
Phosphate Buffer, pH 6.8
Prasugrel HCl Tablet II (Paddle) 75 Citrate-Phosphate buffer 900 10, 15, 20, 30 and 10/04/2012
(0.023M Citric acid+0.026M 45
Sodium Phosphate, Dibasic),
pH 4.0
Pravastatin Sodium Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 20 and 30 02/13/2004
Praziquantel Tablet Refer to USP 06/25/2015
Prednisolone Tablet Refer to USP 11/25/2008
Prednisolone Acetate Ophthalmic Develop an in vitro release 05/15/2014

Suspension method
Prednisolone Sodium Phosphate Tablet (Orally II (Paddle) 50 22 mM Sodium Acetate Buffer, 500 5, 15, 30, 45 and 60 09/03/2008
Disintegrating) pH 4.5
Prednisone Tablet (Delayed II (Paddle) with 100 Water 500 1, 2, 3, 3.5, 4, 4.5, 07/31/2013
Release) sinker 5, 5.5, 6, 7, 8 and
10 hours
Prednisone Tablet Refer to USP 12/24/2015
Pregabalin Tablet (Extended II (Paddle) 50 0.06 M HCl 900 1, 2, 4, 6, 8, 10, 12, 02/08/2018
Pregabalin Capsule II (Paddle) with 50 0.06 N HCl 900 10, 20, 30 and 45 01/15/2015
sinker
Primaquine Phosphate Tablet Refer to USP 05/28/2015
Primidone Tablet Refer to USP 01/14/2008
Procarbazine HCl Capsules II (Paddle) 50 Water 900 10, 20, 30, 45 and 01/14/2008
60
48 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Prochlorperazine Rectal Suppository I (Suppository, 100 0.1 N HCl at 38° C 900 10, 20, 30 and 45 08/17/2006
dissolution
baskets,
palmieri type)
Progesterone Vaginal Insert II (Paddle) 50 0.25% sodium dodecyl sulfate 900 5, 10, 15, 20 and 10/04/2012
(SDS) in DI water 30
Progesterone Capsule Develop a quantitative rupture 04/08/2010

test
Promethazine HCl Rectal Suppository Develop a method to 10/20/2016

Promethazine HCl Tablet Refer to USP 07/25/2007
Propafenone HCl Tablet Refer to USP 11/02/2017
Propafenone HCl Capsule (Extended Refer to USP 11/02/2017

Release)
Propranolol HCl Tablet Refer to USP 03/03/2011
Propranolol HCl Capsule (Extended Refer to USP 07/25/2007

Release)
Propylthiouracil Tablet Refer to USP 06/07/2012
Protriptyline HCl Tablet Refer to USP 01/14/2008
Pseudoephedrine HCl Tablet (Extended Refer to USP 01/14/2008

Release)
Pseudoephedrine HCl/Triprolidine Tablet Refer to USP 01/15/2010

HCl
Pyrazinamide Tablet Refer to USP 10/20/2016
Pyridostigmine Bromide Tablet Refer to USP 06/10/2009
Pyridostigmine Bromide Tablet (Extended II (Paddle) 50 Water 900 1, 2, 4, 6, 8 and 12 06/10/2009

Release) hours
Pyrimethamine Tablet Refer to USP 06/25/2015
Quetiapine Fumarate Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 02/18/2004
Quetiapine Fumarate Tablet (Extended I (Basket, with 200 0.05M citric acid and 0.09 N 900 [solution A]. 1, 2, 4, 6, 8, 10, 12, 01/31/2013
Release) 20 mesh) NaOH (pH 4.8) [solution A]. At 1000 [final] 16, 20, and 24
5 hrs, pH adjusted to 6.6 by hours
addition of 100 mL of 0.05M
dibasic sodium phosphate and
0.46N NaOH [solution B]
Quinapril HCl Tablet Refer to USP 07/25/2007
Quinine Sulfate Capsule Refer to USP 01/14/2008
Rabeprazole Sodium Tablet (Delayed II (Paddle) 100 700 mL 0.1 N HCl (Acid stage), Acid stage: 700; Acid stage: 120; 09/22/2011
Release) after two hours add 300 mL of Buffer stage: 1000 Buffer stage: 10, 20,
0.6 M Tris buffer; adjust to pH 30, and 45
8.0 (Buffer stage) with 2 N HCl
or 2 N NaOH . Stabilize the
samples with the addition of 0.5
N NaOH
Rabeprazole Sodium Capsule (Delayed II (Paddle) Acid Stage: 75 rpm; Acid Stage:0.1 N HCl; Buffer Acid Stage: 750; Acid Stage: 120; 05/15/2014
Release) Buffer Stage: 60 Stage: 0.05 M Phosphate Buffer Stage:1000 Buffer Stage: 10,
rpm Buffer, pH 6.8 (After Acid 15, 20, 25, 30 and
Stage, add 250 mL of 0.2 mol/L 45
trisodium phosphate solution).
49 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Raloxifene HCl Tablet II (Paddle) 50 0.1% Polysorbate 80 in water 1000 10, 20, 30 and 45 02/18/2004
Raltegravir Potassium Tablet (Chewable) II (Paddle) 50 Water(deareated) 900 5, 10, 15, 20 and 30 05/28/2015
Raltegravir Potassium Tablet II (Paddle) with 100 Water (Deaerated) 900 15, 30, 45, 60 and 04/02/2009
option to use a 120
sinker
Ramelteon Tablet II (Paddle) 50 Water 900 10, 20, 30 and 45 04/02/2009
Ramipril Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15 and 30 09/03/2008
Ramipril Capsule II (Paddle) 50 0.1 N HCl 500 10, 20, 30 and 45 02/18/2004
Ranitidine HCl Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 02/18/2004
Ranitidine HCl Tablet (Effervescent) Develop a dissolution method 04/08/2010
Ranitidine HCl Tablet Refer to USP 07/25/2007
Ranolazine Tablet (Extended Develop a dissolution method 02/07/2019

Release)
Rasagiline Mesylate Tablet II (Paddle) 50 0.1 N HCl 500 10, 15, 30 and 45 01/29/2010
Regorafenib Tablet II (Paddle) 75 Acetate Buffer pH 4.5 with 900 10, 15, 20, 30 and 06/25/2015
0.1% Sodium Dodecyl Sulfate 45
(SDS)
Repaglinide Tablet Refer to USP 07/25/2007
Ribavirin Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 02/18/2004
Ribavirin Capsule I (Basket) 100 Water (deaerated) 900 10, 20, 30 and 45 02/18/2004
Ribociclib Tablet II (Paddle) 50 0.01N HCl (Degassed) 900 10, 15, 20, 30, 45 11/02/2017
and 60
Rifabutin Capsule Refer to USP 12/15/2009
Rifampin Capsule Refer to USP 06/18/2007
Rifapentine Tablet II (Paddle) 50 0.8% SLS in Phosphate Buffer, 900 10, 20, 30, 45, 60 02/25/2004
pH 7.0 and 90
Rifaximin (200 mg) Tablet II (Paddle) 75 0.1M sodium phosphate buffer 1000 10, 20, 30, 45, 60, 07/21/2011
pH 7.4 containing 0.45% 90 and 120
Sodium Lauryl Sulfate
Rifaximin (550 mg) Tablet II (Paddle) 75 0.1M sodium phosphate buffer 1000 10, 20, 30, 45, 60, 07/21/2011
pH 7.4 containing 0.8% Sodium 90 and 120
Lauryl Sulfate
Rilpivirine HCl Tablet II (Paddle) 75 0.5% Polysorbate 20 in 0.01N 900 10, 20, 30, 45 and 08/15/2013
HCl (pH=2.0) 60
Riluzole Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 02/18/2004
60
Rimantadine HCl Tablet II (Paddle) 50 Water 900 10, 20, 30, and 45 01/03/2007
Rimexolone Ophthalmic Develop a method to 06/30/2016

Riociguat Tablet II (Paddle) 75 pH 6.8 Phosphate Buffer with 900 5, 10, 15, 20 and 30 12/24/2015
0.1% Sodium Lauryl Sulfate
[SLS]
Risedronate Sodium Tablet Refer to USP 07/01/2010
50 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Risedronate Sodium Tablet (Delayed II (Paddle) 75 Acid stage: 0.1 N HCl; Buffer Acid stage: 500; Acid stage: 120; 01/26/2012
Release) stage: Phosphate buffer, pH 6.8 Buffer stage: 500 Buffer Stage: 10,
15, 20, 30 and 45
Risedronate Sodium/Calcium Tablet (Copackaged) For Risedronate Tablets: Refer 07/01/2010

Carbonate to USP; For Calcium Carbonate
Tablets: Refer to USP.
Risperidone Injectable Develop a dissolution method 01/15/2010

using USP IV (Flow-Through
Agency
Risperidone Tablet II (Paddle) 50 0.1 N HCl 500 10, 20, 30, 45 and 03/04/2006
60
Risperidone Tablet (Orally II (Paddle) 50 0.1 N HCl 500 5, 10, 15 07/23/2004

Disintegrating)
Ritonavir Tablet Refer to USP 01/15/2015
Ritonavir Capsule Refer to USP 01/15/2015
Ritonavir Powder I (Basket -100 100 0.1 N HCl 900 5, 10, 15, 20 and 30 11/16/2017
mesh)
Rivaroxaban (10 mg) Tablet II (Paddle) 75 Acetate Buffer pH 4.5, 0.2% 900 10, 15, 20, 30 and 01/15/2015
sodium dodecyl sulfate (SDS) 45
Rivaroxaban (15 and 20 mg) Tablet II (Paddle) 75 Acetate Buffer pH 4.5, 0.4% 900 10, 15, 20, 30 and 01/15/2015
SDS 45
Rivaroxaban (2.5 mg) Tablet II (Paddle) 75 Acetate Buffer pH 4.5 900 10, 15, 20, 30 and 02/07/2019
45
Rivastigmine Film, Transdermal Modified USP 50 0. 9 % NaCl at 32º C 500 1, 2, 4, 7, 9 and 12 06/10/2009
Type VI hours
(cylinder)
Rivastigmine Tartrate Capsule II (Paddle) 50 Water (deaerated) 500 10, 20, 30 and 45 01/03/2007
Rizatriptan Benzoate Tablet (Orally II (Paddle) 50 Water (deaerated) 900 5, 10 and 15 02/18/2004
Disintegrating)
Rizatriptan Benzoate Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/18/2004
Roflumilast Tablet II (Paddle) 50 1.0% SDS (sodium dodecyl 1000 5, 10, 15, 20, 30 08/15/2013
sulfate) in Phosphate Buffer, pH and 45
6.8
Rolapitant HCl Tablet II (Paddle) 50 0.05 M Sodium Acetate buffer, 900 10, 15, 20, 30 and 10/20/2016
pH 4.0 45
Ropinirole HCl Tablet Refer to USP 05/15/2014
Ropinirole HCl Tablet (Extended II (Paddle) 100 pH 4.0 Citrate-THAM Buffer 500 1, 2, 4, 6, 8, 12, 16, 08/27/2009
Rosiglitazone Maleate Tablet II (Paddle) 50 0.01M Acetate Buffer, pH 4.0 900 10, 20, 30 and 45 02/24/2004
Rosuvastatin Calcium Tablet II (Paddle) 50 0.05 M Sodium Citrate Buffer 900 10, 20, 30 and 45 11/10/2010
pH 6.6 ± 0.05
Rotigotine Transdermal Paddle over 50 Phosphate Buffer, pH 4.5 at 900 15, 30, 60, 90, 120, 07/15/2009
Disk (Apparatus 32°C 150 and 180
5)
Rucaparib Tablet II (Paddle) 75 0.01 N HCl 900 5, 10, 15, 20 and 01/19/2017
30
51 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Rufinamide Suspension II (Paddle) 50 2.0% SDS (sodium dodecyl 900 5, 10, 15, 20 and 30 08/15/2013
sulfate) in water
Rufinamide Tablet Refer to USP 08/15/2013
Ruxolitinib Phosphate Tablet II (Paddle) 75 0.1 N HCI 900 5, 10, 15, 20 and 30 06/25/2015
Sacubitril/Valsartan Tablet I (Basket) 75 Phosphate Buffer, pH 900 10, 15, 20, 30 and 10/24/2019
6.8[degassed] 45
Safinamide Mesylate Tablet II (Paddle) 100 0.1 N HCL with Sodium 900 5, 10, 15, 30, 45 11/02/2017
Chloride [2% (wt/vol) solution], and 60
pH 1.2
Sapropterin Dihydrochloride Powder for II (Paddle) 50 0.1 N HCl 900 2.5, 5, 7.5, 10 and 06/02/2016
Oral Solution 15
Sapropterin Dihydrochloride Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 20 10/06/2008
Saquinavir Mesylate Tablet II (Paddle) 50 Citrate Buffer (pH 3.0) 900 10, 20 , 30 and 45 09/13/2007
Saquinavir Mesylate Capsule Refer to USP 09/13/2007
Saxagliptin HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30 08/15/2013
and 45
Scopolamine Transdermal Reciprocating Stroke depth: 2-3 Distilled Water 25 × 150 mm test- 1, 2, 4, 6, 12, 18, 07/15/2009
disk (Apparatus cm; 30-60 cycles tubes containing 20 24, 36, 48, and 72
7) per minute mL hours
Secnidazole Granule I (Basket) 50 Phosphate Buffer, pH 6.8 900 0.5, 1, 1.5, 2, 2.5, 3, 11/16/2017
3.5 and 4 hours
Selegiline HCl Capsule Refer to USP 01/15/2015
Selegiline (20 mg/20 cm2 and 30 Transdermal Paddle over 50 0.1 M Phosphate buffer, 500 1, 2, 4, 8, 12, 16, 20 07/15/2009
mg/30 cm2) Disk (Apparatus monobasic, pH 5 at 32°C and 24 hours
5)
Selegiline (40 mg/40 cm2) Transdermal Rotating 50 0.1 M Phosphate buffer, 1000 1, 2, 4, 8, 12, 16, 20 07/15/2009
Cylinder monobasic, pH 5 at 32°C and 24 hours
(Apparatus 6)
Selegiline HCl Tablet (Orally I (Basket) 50 Water 500 5, 10, 15 and 20 10/06/2008
Disintegrating)
Selexipag Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20 and 30 03/17/2016
Sertraline HCl Tablet II (Paddle) 75 0.05 M Sodium Acetate Buffer, 900 10, 20, 30 and 45 02/20/2004
pH 4.5
Sevelamer Carbonate Tablet Disintegration Testing in 0.1 N 10/06/2008

HCl as per USP <701>
Sevelamer HCl Capsule Disintegration Testing in 0.1 N 04/09/2008

Sevelamer HCl Tablet Disintegration Testing in 0.1 N 04/09/2008

Sibutramine HCl Capsule II (Paddle) 50 0.05 M Acetate Buffer, pH 4.0 500 10, 20, 30, 45 and 02/25/2004
60
Sildenafil Citrate Tablet I (Basket) 100 0.01 N HCl 900 5, 10, 15 and 30 03/04/2006
Sildenafil Citrate Suspension II (Paddle) 50 McIlvaine Buffer, pH 5.0 500 5, 10, 15, 20 and 30 05/28/2015
Silodosin Capsule II (Paddle) with 50 0.1 N HCl 900 5, 10, 15, 20 and 06/07/2012
sinker 30
52 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Simeprevir Sodium Capsule II (Paddle) 75 0.05 M Phosphate Buffer, pH 900 10, 15, 20, 30 and 05/28/2015
6.8 with 1.0% polysorbate 20 45
Simvastatin Tablet Refer to USP 06/18/2007
Simvastatin Suspension II (Paddle) 50 Phosphate Buffer, pH 7.0, with 900 10, 15, 20, 30 and 12/22/2016
0.14% sodium dodecyl sulfate 45
(SDS)
Simvastatin Tablet (Orally II (Paddle) 75 0.15% SDS Buffer, pH 6.8 900 5, 10, 15 and 30 09/03/2008
Disintegrating)
Sirolimus Tablet Basket (20 120 0.4% SLS in water 500 10, 20, 30, 45, 60 03/14/2007
mesh) and 120
Sitagliptin Phosphate Tablet I (Basket) 100 Water 900 5, 10, 15, 20 and 30 07/01/2010
Sitagliptin Phosphate/Simvastatin Tablet II (Paddle) with 100 10 mM Sodium phosphate 900 5, 10, 15, 20, 30, 10/31/2013
stainless steel buffer containing 1% Tween 80 and 45
stationary with 50 µg/mL Butylated
quadrangular hydroxyanisole
hanging basket
Sodium Iodide I-123 Capsule I (Basket) 100 Water (deaerated) 500 5, 10, 15 and 30 07/14/2008
Sodium Phenylbutyrate Powder for Oral II (Paddle) 75 Simulated Intestinal Fluid 900 15, 30, 45, 60 and 04/02/2009
90
Sodium Phosphate Dibasic Tablet II (Paddle) 100 Water (deionized) 900 20, 30, 45, 60 and 01/15/2010
Anhydrous/Sodium Phosphate 90
Monobasic Monohydrate
Sofosbuvir Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 900 5, 10, 15, 20 and 30 05/28/2015
6.8
Sofosbuvir/Velpatasvir Tablet II (Paddle) 75 50 mM sodium acetate 900 5, 10, 15, 20 and 30 10/20/2016
buffer,pH 5.0, with 0.5% w/v
Cetyltrimethyl ammonium
bromide (CTAB)
Solifenacin Succinate Tablet II (Paddle) 50 Water 900 10, 15, 30 and 45 02/19/2008
Sonidegib Phosphate Capsule II (Paddle) with 75 Tier 1: 0.1 M HCl with 1.0% Tier 1: 900; Tier 2: 15, 30, 45, 60, and 03/17/2016
sinker SDS; Tier II: Stage 1: 850 mL Stage 1: 850 mL, 90 minutes
of 0.1 N HCl solution with Stage 2: 900 mL
pepsin [250’000 units/L]. Stage
2: After 10 minutes add 50 mL
of 18% SDS in 0.1 N HCl
Sorafenib Tosylate Tablet II (Paddle) 75 0.1 M HCl with 1% SDS 900 5, 10, 15, 20 and 30 06/10/2009
Spironolactone Tablet Refer to USP 04/15/2008
Stavudine Capsule Refer to USP 06/18/2007
Succimer Capsule II (Paddle) 50 0.01 N Phosphoric Acid 900 10, 20, 30, 45, 60 02/20/2004
and 90
Sucralfate Suspension II (Paddle) 75 0.1N HCl/0.067 M KCl, pH 1.0 900 10, 20, 30 and 45 03/04/2006
Sucralfate Tablet II (Paddle) 75 0.1 N HCl/0.067 M KCl, pH 1.0 900 15, 30, 45, 60, 180, 04/02/2009
240 and 480
Sucroferric Oxyhydroxide Tablet (Chewable) II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30, 45 11/02/2017
and 60
Sulfadiazine Tablet Refer to USP 07/14/2008
Sulfamethoxazole/Trimethoprim Suspension II (Paddle) 50 1 mL of 0.2 N HCl in water 900 10, 20, 30, 45, 60 02/25/2004
and 90
Sulfamethoxazole/Trimethoprim Tablet Refer to USP 01/14/2008
53 of 59 10/29/2019, 11:47 AM
Recommended
Sampling Times Date
Sulfasalazine Tablet (Delayed Refer to USP 12/15/2009

Release)
Sulfasalazine Tablet Refer to USP 12/15/2009
Sulfisoxazole Acetyl Oral Suspension II (Paddle) 30 1% SLS in 0.1N HCl 900 15, 30, 45, 60 and 08/17/2006
(Pediatric) 90
Sumatriptan Succinate Tablet II (Paddle) 30 0.01 N HCl 900 5, 10, 15 and 30 03/04/2006
Sunitinib Malate Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 30 and 45 10/30/2009
Suvorexant Tablet II (Paddle) with 75 0.4% Sodium Lauryl Sulfate in 900 5, 10, 15, 20, 30 09/03/2015
sinker Water and 45
Tacrolimus Capsule II (Paddle) 50 Hydroxypropyl Cellulose 900 30, 60, 90 and 120 02/20/2004
Solution (1 in 20,000). Adjust to
pH 4.5 by Phosphoric Acid
Tacrolimus Tablet (Extended II (Paddle) 100 0.005% HPC in Water with 900 0.5, 1, 2.5, 4.5, 6.5, 06/30/2016
Release) 0.50% SLS adjusted to pH 4.5 8.5 and 12 hours
Tadalafil Tablet II (Paddle) 50 0.5% Sodium Lauryl Sulfate 1000 10, 20, 30 and 45 01/26/2006
Tamoxifen Citrate Tablet Refer to USP 04/02/2009
Tamsulosin HCl Capsule II (Paddle) 100 0-2 hours: 0.003% polysorbate 500 1, 2, 3, 6, 8, and 10 03/26/2007
80, pH 1.2 2-8 hours: hours
phosphate buffer, pH 7.2
Tapentadol HCl Tablet (Extended II (Paddle) with 100 0.05 M Phosphate Buffer of pH 900 0.5, 1, 2, 3, 4, 6, 8, 10/31/2013
Release) sinker 6.8, Simulated intestinal fluid 10 and 12 hours
(without enzyme)
Tapentadol HCl Tablet I (Basket) 75 0.1 N HCl 900 10, 20, 30, 45 and 10/28/2010
60
Tasimelteon Capsule II (Paddle) with 50 0.1 N HCl 500 5, 10, 15, 20 and 30 09/03/2015
sinker
Tedizolid Phosphate Tablet II (Paddle) 60 0.05 M phosphate buffer pH 6.8 900 5, 10, 15, 20 and 30 06/02/2016
Telaprevir Tablet II (Paddle) 50 1% SLS in Water 900 5, 10, 15, 20 and 30 05/09/2013
Telbivudine Tablet II (Paddle) 50 0.1 N HCl 900 15, 30 and 45 04/02/2009
Telithromycin Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/03/2007
Telmisartan Tablet Refer to USP 01/05/2012
Temazepam Capsule Refer to USP 01/14/2008
Temozolomide Capsule I (Basket) 100 Water 500 (for 5 mg); 900 10, 20, 30, and 45 08/11/2008
ml (for other
strengths)
Tenofovir Alafenamide Fumarate Tablet II (Paddle) 75 50 mM Sodium Acetate buffer 500 5, 10, 15, 20 and 01/19/2017
pH 4.5 30
Tenofovir Disoproxil Fumarate Powder for Oral II (Paddle) 100 0.2% polysorbate 80 in 0.01 M 900 10, 20, 30, 45, 60 01/31/2013
HCl and 75
Tenofovir Disoproxil Fumarate Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, and 45 01/03/2007
Terazosin HCl Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 02/20/2004
60
Terazosin HCl Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45, 60 02/20/2004
and 90
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Recommended
Sampling Times Date
Terbinafine HCl Tablet II (Paddle) 50 Citrate Buffer, pH 3.0 adjusted 500 10, 20, 30 and 45 02/20/2004
with HCl
Terconazole Suppository (Vaginal) I (with Palmieri 100 0.12 N HCl with 1% SLS 900 15, 30, 45, 60, 90, 10/08/2009
type basket) 120 and 150
Teriflunomide Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 1000 5, 10, 15, 20, 30 05/15/2014
6.8 and 45
Testosterone Pellet Implant Develop a dissolution method 11/25/2008
Testosterone Film, Transdermal V (Paddle over 50 0.1 M sodium chloride 900 1, 3, 5, 7, 11, 16, 20 06/30/2011
(Extended Release) disk). Paddle 25 containing 2.5% (v/v) of Tween and 24 hours
mm above the 40 at 32 ± 0.5°C. Delivery
film on the disk. surface faces upwards towards
the media.
Testosterone Buccal Tablet II (Paddle, may 60 1% sodium dodecyl sulfate in 1000 1, 2, 4, 6, 10, 12 01/03/2007
(Extended Release) use sinker) double distilled water and 24 hours
Tetrabenazine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 30 and 09/01/2011
45
Tetracycline HCl Capsule Refer to USP 06/24/2010
Tetracycline HCl Tablet Refer to USP 01/29/2010
Thalidomide Capsule II (Paddle) 100 1.5% (w/v) SLS (pH 3.0, adj w/ 900 10, 20, 30, 60 and 03/04/2006
HCl) 90
Theophylline Capsule (Extended Refer to USP 900 10/06/2008

Release)
Theophylline (100 mg and 200 mg) Tablet (Extended II (Paddle) 50 SGF without Enzyme, pH 1.2 900 1, 4, 8, 12 hours 10/06/2008
Release) during 1st hour. Phosphate
Buffer at pH 7.5 from end of
hour 1 through the duration of
testing
Theophylline (300 mg and 450 mg) Tablet (Extended II (Paddle) 50 SGF without Enzyme, pH 1.2 900 1, 4, 8, 12 hours 10/06/2008
Release) during 1st hour. Phosphate
Buffer at pH 7.5 from end of
hour 1 through the duration of
testing
Theophylline (600 mg and 400 mg) Tablet (Extended I (Basket) 100 SGF without enzyme, pH 1.2 900 1, 2, 4, 8, 12 and 24 10/06/2008
Release) during 1st hour. SIF without hours
enzyme from end of hour 1
through the duration of the
testing
Thioguanine Tablet Refer to USP 07/15/2009
Tiagabine HCl Tablet II (Paddle) 50 Water 900 5, 10, 15, 20 and 30 01/03/2007
Ticagrelor Tablet II (Paddle) 75 0.2% w/v Polysorbate 80 in 900 10, 20, 30, 45, 60 06/25/2015
water and 75
Ticlopidine HCl Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 02/19/2004
60
Timolol Maleate Tablet Refer to USP 07/31/2013
Tinidazole Tablet I (Basket) 100 Water (Deaerated) 900 10, 20, 30 and 45 01/03/2007
Tiopronin Tablet I (Basket) 100 0. 08N HCl containing 0.2% w/v 900 10, 15, 20, 30 and 03/02/2017
NaCl 45
Tipiracil HCl/Trifluridine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 11/02/2017
Tipranavir Capsule II (Paddle) 50 0.05 M phosphate buffer pH 6.8 900 15, 30, 45 and 60 12/03/2007
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Recommended
Sampling Times Date
Tizanidine HCl Capsule II (Paddle) 50 0.01 N HCl 500 5, 10, 15 and 30 02/20/2004
Tizanidine HCl Tablet I (Basket) 100 0.1 N HCl 500 5, 10, 15 and 30 02/20/2004
Tofacitinib Citrate Tablet I (Basket) 100 0.1N HCl 900 5, 10, 15, 20 and 30 06/25/2015
Tofacitinib Citrate Tablet (Extended II (Paddle) with 50 Phosphate Buffer, pH 6.8 900 1, 1.5, 2, 2.5, 3, 4, 6 07/28/2016
Release) option to use a and 8 hours
sinker
Tolcapone Tablet Refer to USP 05/09/2013
Tolterodine Tartrate Tablet II (Paddle) 50 SGF without enzymes, pH 1.2 900 5, 10, 15 and 30 02/20/2004
Tolterodine Tartrate Capsule (Extended I (Basket) 100 Phosphate buffer (pH 6.8) 900 1, 3, 7 hours 06/18/2007
Release)
Tolvaptan Tablet II (Paddle) 50 0.22% Sodium Lauryl Sulfate 900 10, 15, 20, 30 and 02/14/2014
(SLS) in Water 45
Topiramate Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 20 and 30 02/19/2004
Topiramate Capsule (Sprinkle) II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 02/19/2004
60
Topiramate Capsule (Extended I (Basket) 100 50 mM Tris buffer, pH 7.2 900 0.5, 1, 2, 4, 6 and 8 06/25/2015
Release) hours
Topiramate Capsule (Extended II (Paddle) 50 0.05 M Phosphate Buffer, pH 750 1, 2, 3, 4, 6 and 8 08/14/2014
Release) 7.5 hours
Topotecan HCl Capsule II (Paddle) 50 Acetate Buffer with 0.15% SDS, 500 5, 10, 20, 30 and 45 04/27/2009
pH 4.5
Toremifene Citrate Tablet II (Paddle) 50 0.02 N HCl 1000 10, 20, 30 and 45 02/20/2004
Torsemide Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/20/2004
Tramadol Capsule (Extended I (Basket) 100 Water (Deaerated ) 900 0.5, 1, 2, 3, 5, 7, 9, 09/03/2015
Release) 12, 16, 20 and 24
hours
Tramadol HCl Tablet I (Basket) 100 0.1 N HCl 900 10, 20, 30 and 45 02/19/2004
Tramadol HCl Tablet (Extended I (Basket) 75 0.1 N HCl 900 2, 4, 8, 10 and 16 01/03/2007
Release) hours
Trametinib Dimethyl Sulfoxide Tablet II (Paddle) 60 pH 4.5, 50 mM Sodium Acetate 500 5, 10, 15, 20 and 30 12/24/2015
with 0.75% Sodium Lauryl
Sulfate [SLS]
Trandolapril Tablet II (Paddle) 50 Water (deaerated) 500 10, 20, 30, 45 and 02/20/2004
60
Trandolapril/Verapamil HCl Tablet (Extended II (Paddle) 50 For Trandolapril: Water; For For Trandolapril: For Trandolapril: 5, 12/19/2008
Release) Verapamil: 0-1 hour Gastric 500; For Verapamil: 10, 20, 30 and 45;
Fluid w/o Pepsin pH=1.2, 1-8 900 For Verapamil: 1, 2,
hour Intestinal Fluid w/o 3.5, 5 and 8 hours
Pancreatin
Tranexamic Acid Tablet II (Paddle 50 Water 900 15, 30, 45, 60, 90 12/23/2010
and 120
Tranylcypromine Sulfate Tablet Refer to USP 10/31/2013
Trazodone HCl Tablet Refer to USP 12/15/2009
Trazodone HCl Tablet (Extended II (Paddle) 50 Water 900 1, 2, 3, 5, 8, 10, 12, 03/02/2017
Release) 16, 20 and 24
hours
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Recommended
Sampling Times Date
Treprostinil Diolamine Tablet (Extended I (Basket) 100 0.05 M Phosphate Buffer, pH 500 1, 2, 4, 6, 8, 12, 16, 06/02/2016
Release) 6.8 (deaerated) 20 and 24 hours
Tretinoin Capsule I (Basket) 100 0.5% solid 900 10, 15, 20, 30 and 08/05/2010
Lauryldimethylamine-oxide 45
(LDAO) in 0.05M Phosphate
Buffer, pH 7.8
Triamcinolone Acetonide Intra-Articular, For II (Paddle) 75 0.3% SDS in 10 mM phosphate 1000 1, 2, 4, 8, 12, 16, 02/08/2018
Suspension (Extended buffer, pH 7.2 + 0.02% sodium 24, 36, 48, 72, 96
Release) azide @35°C and 120 hours
Triamcinolone Acetonide Injectable Suspension Develop a dissolution method 01/15/2010

using USP IV (Flow-Through
Agency
Triamterene Capsule Refer to USP 06/18/2007
Trientine HCl Capsule Refer to USP 07/31/2013
Trimethoprim Tablet Refer to USP 01/29/2010
Trimipramine Maleate Capsule I (Basket) 100 Water (deaerated) 1000 10, 20, 30, 45, 60 03/04/2006
and 90
Triptorelin Pamoate Injectable Suspension II (Paddle) 200 Water-Methanol (95:5); 500 1, 6, 12, 24, 48 and 07/14/2008
Reconstitute vial in 2 mL Water 72 hours
for Injection, add to 500 mL
medium at 37°C
Triptorelin Pamoate For Intramuscular II (Paddle) 75 50 mL of methanol to 950 mL of 950 1, 8, 24, 96, and 11/16/2017
Suspension (Extended water 168 hours
Release)
Trospium Chloride Capsule (Extended II (Paddle) with 50 0.1 N HCl, pH 1.1 for 2 hrs and 0-2 hrs: 750 ml, 2, 3, 4, 6, 8, 12 and 07/15/2010
Release) sinker then add 200 mL of 0.1 N After 2 hrs: 950 ml. 16 hours
NaOH in 200 mM Phosphate
Buffer. Adjust pH to 7.5 using 2
N HCl and/or 2N NaOH
Trospium Chloride Tablet II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 12/03/2007
Ulipristal Acetate Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 01/31/2013
30
Ursodiol Capsules Refer to USP 07/21/2009
Ursodiol Tablet Refer to USP 04/15/2008
Valacyclovir Hydrochloride Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 08/27/2009
60
Valbenazine Capsule II (Paddle) with 50 Tier 1: 0.1N HCl; Tier 2: 0.1N 900 5, 10, 15, 20 and 30 11/02/2017
sinker HCl containing pepsin (750,000
units per 1000 mL)
Valganciclovir HCl Tablet Refer to USP 01/15/2015
Valproic Acid Capsule Refer to USP 12/15/2009
Valsartan Tablet Refer to USP 07/28/2016
Valsartan Capsule II (Paddle) 50 0.067 M Phosphate Buffer, pH 1000 10, 20, 30 and 45 12/13/2004
6.8
Vancomycin hydrochloride Capsule Refer to USP 01/14/2008
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Recommended
Sampling Times Date
Vandetanib Tablet II (Paddle) 50 pH 1.2 Buffer [0.05 M KCl in 1000 5, 10, 15, 20 and 30 06/25/2015
water, adjust the pH with HCl or
NaOH]
Vardenafil HCl Tablet (Orally II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 05/15/2014
Disintegrating)
Vardenafil HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 12/20/2005
Varenicline Tartrate Tablet I (Basket) 100 0.01 N HCl 500 5, 10, 15 and 30 12/03/2007
Vemurafenib Tablet II (Paddle) 75 1% 900 10, 15, 20, 30 and 05/28/2015

hexadecyltrimethylammonium 45
bromide (HTAB) in 0.05 M
Phosphate Buffer, pH 6.8
Venetoclax Tablet III 20 dpm Phosphate Buffer, pH 6.8 with 250 0.25, 0.5, 0.75, 1, 07/28/2016
(Reciprocating 0.4% sodium dodecyl sulfate 1.5, 2, 3, 3.5 and 4
Cylinder) (SDS) [3 small drops of hours
[Bottom Screen: antifoaming agent may be
200 mesh used]
stainless steel]
Venlafaxine HCl Capsule (Extended I (Basket) 100 Water 900 2, 4, 8, 12 and 20 01/03/2007
Release) hours
Venlafaxine HCl Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/19/2004
Venlafaxine HCl Tablet (Extended II (Paddle) 50 Water (deaerated) 900 1, 2, 4, 6, 8, 12, 16, 02/14/2014
Verapamil HCl Tablet Refer to USP 11/04/2008
Verapamil HCl Capsule (Extended Refer to USP 08/27/2015

Release)
Verapamil HCl Tablet (Extended Refer to USP 06/24/2010

Release)
Verteporfin Injectable Develop a method to 08/14/2014

characterize in vitro release.
Vigabatrin Tablet II (Paddle) 50 Water 900 5, 10, 15, 20 and 30 06/25/2015
Vilazodone HCl Tablet II (Paddle) 60 0.1% v/v Glacial acetic acid 1000 10, 15, 20, 30 and 08/14/2014
solution (pH 3.1) 45
Vismodegib Capsule II (Paddle) 75 0.01 N HCl with 1.0% sodium 900 10, 15, 20, 30 and 05/28/2015
lauryl sulfate (SLS) 45
Vorapaxar Sulfate Tablet II (Paddle) 50 41 mM Na2HPO4, 1.5% Citric 900 5, 10, 20, 30, 45 12/24/2015
Acid, pH 3.0 ± 0.5 and 60
Voriconazole Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 11/25/2008
Voriconazole Suspension II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/03/2007
Vorinostat Capsule II (Paddle) with 100 2% Tween 80 in Water 900 5, 15, 30, 45 and 60 09/03/2008
sinker
Vortioxetine HBr Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 05/28/2015
45
Warfarin Sodium Tablet Refer to USP 01/29/2010
Zafirlukast Tablet II (Paddle) 50 1% w/v Aqueous Sodium 1000 10. 30, 30 and 45 10/09/2007
Dodecyl Sulfate
Zalcitabine Tablet Refer to USP 900 02/19/2008
Zaleplon Capsule II (Paddle) 75 Deionized Water 900 5, 10, 20, and 30 01/03/2007
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Recommended
Sampling Times Date
Zidovudine Tablet Refer to USP 07/25/2007
Zidovudine Capsule Refer to USP 06/18/2007
Zileuton Tablet II (Paddle) 50 0.05 M SLS in water 900 10, 20, 30, 45 and 02/19/2004
60
Zileuton Tablet (Extended II (Paddle) with 75 0.1 M SDS (sodium dodecyl 900 1, 2, 4, 6, 8, 10 and 08/15/2013
Release) sinker sulfate) in water 12 hours
Zinc Acetate Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 02/19/2004
Ziprasidone HCl Capsule II (Paddle) 75 Tier I: 0.05 M Na phosphate 900 10, 20, 30, 45 and 03/04/2006
buffer, pH 7.5 + 2% SDS (w/w) 60
Tier II: 0.05 M Na phosphate
buffer, pH 7.5 (700ml) + 1%
pancreatin. After 15 min.
incubation, add 200 mL of
phosphate buffer containg 9%
SDS
Zolmitriptan Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 07/21/2009
Zolmitriptan Tablet (Orally II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 06/18/2007
Disintegrating)
Zolpidem Tartrate Tablet (Extended Refer to USP 01/05/2012

Release)
Zolpidem Tartrate Tablet II (Paddle) 50 0.01 N HCl, pH 2.0 900 5, 10, 15 and 30 02/19/2004
Zolpidem Tartrate (1.75 and 3.5 Tablet (Sublingual) II (Paddle) 50 Simulated intestinal fluid 500 1, 3, 5, 7, 10 and 15 08/14/2014
mg) (without enzyme), pH 6.8,
(deaerated)
Zolpidem Tartrate (5 and 10 mg) Tablet (Sublingual) II (Paddle) 75 Phosphate Buffer, pH 6.8 900 1, 3, 5, 7, 10 and 15 08/14/2014
Zonisamide Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/03/2007
Showing 1 to 1,325 of 1,325 entries
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About this Database (https://www.fda.gov/Drugs/DevelopmentApprovalProcess

Acetaminophen Tablet (Extended Refer to USP 03/03/2011

Acetaminophen/Aspirin/Caffeine Tablet Refer to USP 06/25/2015

Acetaminophen/Butalbital/Caffeine Tablet Refer to USP 01/14/2008

Acetaminophen/Hydrocodone Tablet Refer to USP (provide 08/15/2013

Acetaminophen/Oxycodone Tablet Refer to USP 01/14/2008

Acetaminophen/Propoxyphene HCl Tablet Refer to USP 01/15/2010

Acetaminophen/Propoxyphene Tablet Refer to USP 01/15/2010

Acetazolamide Tablet Refer to USP 07/21/2011

Acetazolomide Tablet Refer to USP 07/14/2008

Acetylcysteine Tablet (Effervescent) Develop a dissolution method 07/28/2016

Acitretin Capsule Refer to USP 09/22/2011

Acyclovir Capsule Refer to USP 01/05/2012

Acyclovir Tablet Refer to USP 06/18/2007

Albendazole Tablet Refer to USP 08/15/2013

Albuterol Sulfate Tablet Refer to USP 09/03/2008

Alendronate Sodium Tablet Refer to USP 01/14/2008

Allopurinol Tablet Refer to USP 07/25/2007

Alprazolam Tablet Refer to USP 06/18/2007

Altretamine Capsule Refer to USP 01/29/2010

Amantadine HCl Capsule Refer to USP 12/23/2010

Amiloride HCl Tablet Refer to USP 06/07/2012

Amiloride HCl/Hydrochlorothiazide Tablet Refer to USP 06/07/2012

Aminocaproic Acid Tablet Refer to USP 08/27/2015

Amitriptyline HCl Tablet Refer to USP 01/14/2008

Amlodipine Tablet Refer to USP 07/28/2016

Amlodipine Besylate/Valsartan Tablet Refer to USP 07/28/2016

Amoxicillin Capsule Refer to USP 01/31/2013

Amoxicillin Tablet Refer to USP 01/31/2013

Amoxicillin/Clarithromycin Capsule/Tablet Refer to USP for monographs 02/28/2013

Amoxicillin/Clarithromycin Capsule/Tablet Refer to USP for monographs 02/28/2013

Amoxicillin/Clavulanate Potassium Tablet Refer to USP As appropriate 0, 0.5, 1, 2, 3, 4 and 10/04/2012

Amoxicillin/Clavulanate Potassium Tablet (Chewable) Refer to USP 01/14/2008

Amphetamine Suspension (Extended Develop a dissolution method 12/22/2016

Amphotericin B Injectable (Liposomal) Develop a method to 07/28/2016

Anastrozole Tablet II (Paddle) 50 Water 900 5, 10, 15, and 30 01/03/2007

Aripiprazole Tablet Refer to USP 06/30/2016

Aspirin Capsule Refer to USP 05/28/2015

Aspirin/Butalbital/Caffeine Capsule Refer to USP 06/24/2010

Aspirin/Butalbital/Caffeine Tablet Refer to USP 06/24/2010

Aspirin/Butalbital/Caffeine/Codeine Capsule Refer to USP 08/27/2009

Aspirin/Oxycodone HCl Tablet Refer to USP 01/15/2010

Atenolol Tablet Refer to USP 02/14/2014

Atenolol/Chlorthalidone Tablet Refer to USP 02/14/2014

Atovaquone Oral Suspension Develop a dissolution method 07/21/2009

Atropine Sulfate/ Diphenoxylate Tablet Develop dissolution method(s) 12/22/2016

Azacitidine Injectable Suspension Develop a dissolution method 09/03/2008

Azathioprine Tablet Refer to USP 04/08/2010

Azithromycin Tablet Refer to USP 12/22/2016

Azithromycin Capsule Refer to USP 12/22/2016

Baclofen Tablet Refer to USP 12/15/2009

Bendroflumethiazide/Nadolol Tablet Refer to USP 07/25/2007

Benzonatate Capsule Refer to USP 12/24/2015

Bethanechol Chloride Tablet Refer to USP 10/06/2008

Bisoprolol Fumarate Tablet Refer to USP 06/18/2007

Brimonidine Tartrate/Brinzolamide Ophthalmic Develop a method to 01/15/2015

Brinzolamide Ophthalmic Develop a method to 09/01/2011