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Amprolium Soluble Powder
» Amprolium Soluble Powder contains not less than 95.0 percent and not more than 105.0 percent 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 197U—
Solution: 10 µg per mL, filtered.
Medium: 0.1 N hydrochloric acid.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Diluent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Amprolium.
Assay preparation— Transfer an accurately weighed portion of Soluble Powder, equivalent to about 50 mg of amprolium, to a 100-mL volumetric flask, add about 75 mL of Diluent, and sonicate for about 10 minutes. Allow to cool to room temperature, dilute with Diluent to 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 Procedure in the Assay under Amprolium. Calculate the quantity, in mg, of amprolium (C14H19 ClN4·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., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29–NF24 Page 172
Phone Number : 1-301-816-8178