Amoxicillin Boluses
»Amoxicillin Boluses contain not less than 90.0percent and not more than 110.0percent 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— To a portion of powdered Boluses add 0.1Nhydrochloric acid to obtain a test solution containing about 4mg of amoxicillin per mL.Proceed as directed for the Identificationtest under Amoxicillin Tablets,beginning with “Prepare a Standard solution.”The specified result is obtained.
Disintegration á701ñ: 30minutes,simulated gastric fluid being used instead of water.
Water,Method Iá921ñ: not more than 7.5%.
Assay—
Diluent,Mobile phase,Standard preparation,andChromatographic system— Prepare as directed in the Assayunder Amoxicillin.
Assay preparation— Weigh and finely powder not fewer than 5Boluses.Transfer an accurately weighed portion of the powder,equivalent to about 250mg of amoxicillin,to a 250-mLvolumetric flask,add Diluentto 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.[NOTE—Use this solution within 6hours.]
Procedure— Proceed as directed for Procedurein the Assayunder 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— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 144
Phone Number:1-301-816-8178