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Metronidazole Cream

BRIEFING

Metronidazole Cream. 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 Symmetry C8 brand of column with L7 packing. The typical retention time for metronidazole is about 5 min.

  2. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Kinetex Biphenyl brand of column with L11 packing. The typical retention time for metronidazole is about 31 min.

 (SM1: S. Shane)

 Case ID—SUB-408

USP REFERENCE STANDARDS FOR PURCHASE

USP Metronidazole RS
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