Amoxicillin Boluses
» 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.
Identification
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%.
Assay
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
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