USP NF Hydrocortisone

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OAcial Status: Currently OAcial on 10-Mar-2020
OAcial Date: OAcial as of 31-Dec-2012
Document Type: USP
DocId: 1_GUID-99A7127A-E218-455D-9E16-9F5F49CCE1F2_1_en-US
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© 2020 USPC
Hydrocortisone Ointment
DEFINITION
Hydrocortisone Ointment is Hydrocortisone in a suitable ointment base. It contains NLT 90.0% and NMT 110.0% of the labeled amount
of hydrocortisone (C21H30O5).
L
IDENTIFICATION
• A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST 〈201〉
Sample solution: Transfer a portion of Ointment, equivalent to 5 mg of hydrocortisone, to a \ask. Add 10 mL of methanol, and heat on
A
a steam bath for 5 min with frequent shaking. Cool to solidify the ointment base, and _lter. Use the _ltrate.
Acceptance criteria: Meets the requirements
CI
ASSAY
• PROCEDURE
Diluent: Dilute alcohol (1 in 2)
Mobile phase: Acetonitrile and water (25:75)
FI
Standard stock solution: 500 µg/mL of USP Hydrocortisone RS in alcohol
Standard solution: 50 µg/mL of USP Hydrocortisone RS prepared by mixing Standard stock solution and Diluent (1:9). [NOTE—If alcohol
is used in the _nal dilution of the Sample solution, similarly use alcohol instead of aqueous alcohol in the _nal dilution of the
Standard solution.]
OF
Sample solution: Transfer a quantity of Ointment, nominally equivalent to 10 mg of hydrocortisone, to a 150-mL beaker. Add 40 mL of
alcohol, and heat on a steam bath while stirring to melt and disperse the Ointment. Cool to room temperature, and _lter through
glass wool into a 100-mL volumetric \ask. Repeat the extraction with two 20-mL portions of alcohol, combining the _ltrates in the
100-mL volumetric \ask. Add alcohol to volume, and mix. Quantitatively dilute one volume of this solution with an equal volume of
water, and pass through a membrane _lter of 5-µm pore size. If precipitation occurs on dilution with water, and the solution is still
cloudy after _ltration, dilute the initial Sample solution with alcohol instead of water. Pass this solution through a membrane _lter of
5-µm pore size.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 254 nm
Column: 3.9-mm × 30-cm; packing L1
Injection volume: 10–25 µL
System suitability
[NOTE—Adjust the composition of the Mobile phase so that the retention time of hydrocortisone is about 10 min.]
Sample: Standard solution
Suitability requirements
Relative standard deviation: NMT 3.0% for 5 replicate injections
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of hydrocortisone (C21H30O5) in the portion of Ointment taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response from the Sample solution
rS = peak response from the Standard solution

CS = concentration of USP Hydrocortisone RS in the Standard solution (µg/mL)
CU = nominal concentration of hydrocortisone in the Sample solution (µg/mL)
Acceptance criteria: 90.0%–110.0%
PERFORMANCE TESTS
• MINIMUM FILL 〈755〉: Meets the requirements
SPECIFIC TESTS
• MICROBIAL ENUMERATION TESTS 〈61〉andTESTS FOR SPECIFIED ORGANISMS 〈62〉: It meets the requirements of the tests for absence of
Staphylococcus aureus and Pseudomonas aeruginosa.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed containers.
• USP REFERENCE STANDARDS 〈11〉
USP Hydrocortisone RS
Auxiliary Information- Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
HYDROCORTISONE OINTMENT Gerald Hsu CHM52015 Chemical Medicines Mono-

Senior Scienti_c Liaison graphs 5
Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:

Pharmacopeial Forum: Volume No. 44(6)
Page Information:
USP43-NF38 - 2232
USP42-NF37 - 2183
USP41-NF36 - 2060
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Result = (rU/rS) × (CS/CU) × 100

rU = peak response from the Sample solution

rS = peak response from the Standard solution

CU = nominal concentration of hydrocortisone in the Sample solution (µg/mL)

Acceptance criteria: 90.0%–110.0%

Topic/Question Contact Expert Committee

HYDROCORTISONE OINTMENT Gerald Hsu CHM52015 Chemical Medicines Mono-

Chromatographic Database Information: Chromatographic Database

Most Recently Appeared In:

Current DocID: GUID-99A7127A-E218-455D-9E16-9F5F49CCE1F2_1_en-US

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