BRIEFING

 Metronidazole Vaginal Gel. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

1. The liquid chromatographic procedure in the Assay was validated using the Inertsil C8-3 brand of column with L7 packing. The typical retention time for metronidazole is about 6 min.

2. The liquid chromatographic procedure in the test for Limit of Salicylic Acid Related Compound A was validated using the Inertsil C8-3 brand of column with L7 packing. The typical retention time for metronidazole is about 4 min.

3. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Inertsil C8-3 brand of column with L7 packing. The typical retention time for metronidazole is about 10 min.

 (SM1: S. Shane)

 Correspondence Number—C313492