Amoxicillin Oral Suspension

2/9/2021 Amoxicillin Oral Suspension - British Pharmacopoeia
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Amoxicillin Oral Suspension

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General Notices
Action and use
Penicillin antibacterial.
DEFINITION
Amoxicillin Oral Suspension is a suspension of Amoxicillin Trihydrate in a suitable flavoured vehicle. It is prepared by dispersing the dry
ingredients in the specified volume of Water just before issue for use.
The dry ingredients comply with the requirements for Powders and Granules for Oral Solutions and Oral Suspensions stated under Oral
Liquids.
For the following tests prepare the Oral Suspension as directed on the label. The suspension, examined immediately after preparation
unless otherwise indicated, complies with the requirements stated under Oral Liquids and with the following requirements.
Content of amoxicillin, C16H19N3O5S
When freshly constituted not more than 120.0% of the stated amount. When stored at the temperature and for the period stated on the
label during which the Oral Suspension may be expected to be satisfactory for use, not less than 80.0% of the stated amount.
IDENTIFICATION
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Dilute a quantity of the oral suspension with sufficient sodium hydrogen carbonate solution to produce a solution containing the
equivalent of 0.25% w/v of amoxicillin.
(2) 0.25% w/v of amoxicillin trihydrate BPCRS in sodium hydrogen carbonate solution.
(3) 0.25% w/v of each of amoxicillin trihydrate BPCRS and ampicillin trihydrate BPCRS in sodium hydrogen carbonate solution.
CHROMATOGRAPHIC CONDITIONS
(a) Use a TLC silica gel silanised plate (Merck silanised silica gel 60 F254s (RP-18) plates are suitable).
(b) Use the mobile phase described below.
(c) Apply 1 µL of each solution.

(d) Develop the plate to 15 cm.
(e) After removal of the plate, allow it to dry in air, expose it to iodine vapour until spots appear and examine in daylight.
MOBILE PHASE
https://www.pharmacopoeia.com/bp-2020/formulated-specific/amoxicillin-oral-suspension.html?date=2020-07-01&text=amoxicillin+oral+suspension 1/3
10 volumes of acetone and 90 volumes of a 15.4% w/v solution of ammonium acetate adjusted to pH 5.0 with glacial acetic acid.
SYSTEM SUITABILITY
The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.
CONFIRMATION
The principal spot in the chromatogram obtained with solution (1) is similar in position, colour and size to that in the chromatogram obtained
with solution (2).
TESTS
Acidity or alkalinity
pH, 4.0 to 7.0, Appendix V L.
ASSAY
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Dilute a weighed quantity of the oral suspension containing the equivalent of 60 mg of amoxicillin with sufficient mobile phase A to
produce 100 mL, mix and filter (Whatman GF/C filter paper is suitable).
(2) 0.070% w/v of amoxicillin trihydrate BPCRS in mobile phase A.
(3) 0.0004% w/v of cefadroxil BPCRS and 0.003% w/v of amoxicillin trihydrate BPCRS in mobile phase A.
CHROMATOGRAPHIC CONDITIONS
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil 5 ODS is
suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use an ambient column temperature.

(e) Use a detection wavelength of 254 nm.
(f) Inject 50 µL of each solution.
MOBILE PHASE
8 volumes of mobile phase B and 92 volumes of mobile phase A.
Mobile phase A Mix 1 volume of acetonitrile and 99 volumes of a 25% v/v solution of 0.2M potassium dihydrogen orthophosphate adjusted
to pH 5.0 with 2M sodium hydroxide.
Mobile phase B Mix 20 volumes of acetonitrile and 80 volumes of a 25% v/v solution of 0.2M potassium dihydrogen orthophosphate
adjusted to pH 5.0 with 2M sodium hydroxide.
SYSTEM SUITABILITY
The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to amoxicillin
and cefadroxil is at least 2.0. If necessary, adjust the composition of the mobile phase to achieve the required resolution.
DETERMINATION OF CONTENT
Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of C16H19N3O5S, weight in volume, using the
declared content of C16H19N3O5S in amoxicillin trihydrate BPCRS.
Repeat the procedure using a portion of the oral suspension that has been stored at the temperature and for the period stated on the label
during which it may be expected to be satisfactory for use.
STORAGE
The Oral Suspension should be kept at the temperature and used within the period stated on the label.
LABELLING
The quantity of active ingredient is stated in terms of the equivalent amount of amoxicillin.
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2/9/2021 Amoxicillin Oral Suspension - British Pharmacopoeia

Action and use

Content of amoxicillin, C16H19N3O5S

(b) Use the mobile phase described below.

(c) Apply 1 µL of each solution.

pH, 4.0 to 7.0, Appendix V L.

(d) Use an ambient column temperature.

8 volumes of mobile phase B and 92 volumes of mobile phase A.

to pH 5.0 with 2M sodium hydroxide.

adjusted to pH 5.0 with 2M sodium hydroxide.

declared content of C16H19N3O5S in amoxicillin trihydrate BPCRS.

© Crown Copyright 2019

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