Amprolium Soluble Powder
»Amprolium Soluble Powder contains not less than 95.0percent and not more than 105.0percent of the labeled amount of amprolium (C14H19ClN4·HCl).
Packaging and storage— Preserve in tight containers.
Labeling— Label it to indicate that it is for veterinary use only.
Identification,Ultraviolet Absorption á197Uñ—
Solution: 10µg per mL,filtered.
Medium: 0.1Nhydrochloric acid.
Assay—
Diluent,Mobile phase,Standard preparation,Resolution solution,andChromatographic system— Proceed as directed in the Assayunder Amprolium.
Assay preparation— Transfer an accurately weighed portion of Soluble Powder,equivalent to about 50mg of amprolium,to a 100-mLvolumetric flask,add about 75mLof Diluent,and sonicate for about 10minutes.Allow to cool to room temperature,dilute with Diluentto volume,and mix.Pass through a suitable filter of 0.5-µm or finer porosity,and use the clear filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assayunder Amprolium.Calculate the quantity,in mg,of amprolium (C14H19ClN4·HCl)in the portion of Soluble Powder taken by the formula:
100C(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 157
Phone Number:1-301-816-8178