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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals
1-301-816-8178		 (VET05) Veterinary Drugs 05
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 1556
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.