BRIEFING

 Eletriptan Tablets. 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 brand of column with L7 packing. The typical retention time for eletriptan is about 6 min.

2. The liquid chromatographic procedure in the Organic Impurities test was validated using the Zorbax C8 brand of column with L7 packing. The typical retention time for eletriptan is about 28 min.

 (SM4: R. Nguyen)

 Case ID—SUB-973