BRIEFING

 Acyclovir Cream. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures in the Assay and Organic Impurities test are based on validations performed with the Zorbax Stable Bond-CN brand of column with L10 packing. The typical retention time for acyclovir is about 4 min.

 (SM1: S. Parepalli)

 Case ID—SUB-1003