Ampicillin Boluses
»Ampicillin Boluses contain an amount of ampicillin (as the trihydrate)equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of ampicillin (C16H19N3O4S).
Packaging and storage— Preserve in tight containers.
Labeling— Label the Boluses to indicate that they are for veterinary use only.
Identification— Powder 1or more Boluses,and prepare a solution containing the equivalent of 10mg of ampicillin per mLin a mixture of acetone and 0.1Nhydrochloric acid (4:1):the resulting solution responds to the Identificationtest under Ampicillin Capsules.
Uniformity of dosage units á905ñ: meet the requirements.
Loss on drying á731ñ: not more than 5.0%.
Assay—
Standard preparation— Prepare as directed for Standard Preparationunder Iodometric Assay—Antibiotics á425ñ,using USP Ampicillin RS.
Assay preparation— Place not fewer than 5Boluses in a high-speed glass blender jar containing an accurately measured volume of water,and blend for 4±1minutes.Dilute an accurately measured volume of this stock solution quantitatively and stepwise with water to obtain an Assay preparationcontaining about 1.25mg of ampicillin per mL.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ.Calculate the quantity,in mg,of ampicillin (C16H19N3O4S)in each Bolus taken by the formula:
(T/D)(F/2000)(B-I),
in which Tis the labeled quantity,in mg,of ampicillin in each Bolus;and Dis the concentration,in mg per mL,of ampicillin in the Assay preparationon the basis of the labeled quantity in each Bolus and the extent of dilution.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 152
Phone Number:1-301-816-8178