BRIEFING

 Misoprostol Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this drug product which appeared in PF 26(5) [Sep.–Oct. 2000] has been canceled and is being replaced with a new proposal.

1. The liquid chromatographic procedure for the Assay and Identification B was validated using the Allsphere ODS-1 brand of column with L1 packing. The typical retention time for misoprostol is about 12 min.

2. The liquid chromatographic procedure for the Dissolution test was validated using the Zorbax SB-Phenyl brand of column with L11 packing. The typical retention time for misoprostol is about 8 min.

3. The liquid chromatographic procedure for the Organic Impurities test was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for misoprostol is about 40 min.

 (SM3: H. Ramanathan)

 Case ID—SUB-1575