BRIEFING

 Hydrocortisone Oral Solution. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. The liquid chromatographic procedure in the Assay and Organic Impurities test was validated using the Avantor ACE C18-AR brand of column with L1 packing. The typical retention time for hydrocortisone is about 16 min.

 (SM1: S. Banerjee)

 Case ID—SUB-2729