» Amoxicillin Boluses contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of amoxicillin (C16H19N3O5S).
Packaging and storage Preserve in tight containers, and store at controlled room temperature.
Labeling Label Boluses to indicate that they are for veterinary use only.
USP Reference standards 11
Test solution To a portion of powdered Boluses add 0.1 N hydrochloric acid to obtain a Test solution containing about 4 mg of amoxicillin per mL. Use within 10 minutes after preparation.
Application volume, Developing solvent system, Procedure Proceed as directed for the Identification test under Amoxicillin Tablets.
Disintegration 701: 30 minutes, simulated gastric fluid being used instead of water.
Water, Method I 921: not more than 7.5%.
Diluent, Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Amoxicillin.
Assay preparation Weigh and finely powder not fewer than 5 Boluses. Transfer an accurately weighed portion of the powder, equivalent to about 250 mg of amoxicillin, to a 250-mL volumetric flask, add Diluent to volume, and mix. Sonicate if necessary to ensure complete dissolution of the amoxicillin. Pass a portion of this solution through a filter of 1-µm or finer porosity, and use the filtrate as the Assay preparation. [noteUse 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 the portion of Boluses taken by the formula:
0.25CP(rU / rS)in which the terms are as defined therein.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2198