Ampicillin Soluble Powder
»Ampicillin Soluble Powder is a dry mixture of Ampicillin (as the trihydrate)and one or more suitable diluents and stabilizing agents.It contains 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 it to indicate that it is for veterinary use only.
Identification— Dissolve a quantity of it in a mixture of acetone and 0.1Nhydrochloric acid (4:1)to obtain a solution containing 10mg of ampicillin per mL:the resulting solution responds to the Identificationtest under Ampicillin Capsules.
pHá791ñ: between 3.5and 6.0,in an aqueous solution containing the equivalent of 20mg of ampicillin per mL.
Water,Method Iá921ñ: not more than 5.0%.
Assay—
Standard preparation— Prepare as directed for Standard Preparationunder Iodometric Assay—Antibiotics á425ñ,using USP Ampicillin RS.
Assay preparation— Transfer an accurately weighed quantity of Soluble Powder,equivalent to about 125mg of ampicillin,to a 100-mLvolumetric flask,dissolve in and dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ.Calculate the quantity,in mg,of ampicillin (C16H19N3O4S)in the portion of Soluble Powder taken by the formula:
(F/20)(B-I).
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 153
Phone Number:1-301-816-8178
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