U.S. PHARMACOPEIA

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Amoxicillin for Oral Suspension
» Amoxicillin for Oral Suspension contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of amoxicillin (C16H19N3O5S). It contains one or more suitable buffers, colors, flavors, preservatives, stabilizers, sweeteners, and suspending agents.
Packaging and storage— Preserve in tight containers, and store at controlled room temperature.
Identification— Prepare a solution containing the equivalent of 4 mg of amoxicillin by adding 0.1 N hydrochloric acid to a portion of Amoxicillin for Oral Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification test under Amoxicillin Capsules.
Uniformity of dosage units 905—
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 5.0 and 7.5, in the suspension constituted as directed in the labeling.
Water, Method I 921: not more than 3.0%, except where it is labeled as containing 80 mg of amoxicillin per mL after constitution, the limit is not more than 4.0%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Diluent, Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Amoxicillin.
Assay preparation— Dilute an accurately measured volume of Amoxicillin for Oral Suspension, constituted as directed in the labeling, freshly mixed and free from air bubbles, quantitatively and stepwise in Diluent to obtain a solution containing about 1 mg of anhydrous amoxicillin per mL. Filter a portion of this solution through a suitable filter of 1-µm or finer porosity, and use the filtrate as the Assay preparation. Use this solution within 6 hours.
Procedure— Proceed as directed for Procedure in the Assay under Amoxicillin. Calculate the quantity, in mg, of amoxicillin (C16H19N3O5S) in each mL of the constituted Oral Suspension taken by the formula:
(L/D)(CP/1000)(rU / rS),
in which L is the labeled quantity, in mg per mL, of anhydrous amoxicillin in the constituted Amoxicillin for Oral Suspension; D is the concentration, in mg per mL, of anhydrous amoxicillin in the Assay preparation on the basis of the labeled quantity in the constituted Amoxicillin for Oral Suspension and the extent of dilution; and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 159
Pharmacopeial Forum : Volume No. 27(6) Page 3243
Phone Number : 1-301-816-8223