BRIEFING

 Dabigatran Etexilate Capsules. 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 ODS-3 brand of column with L1 packing. The typical retention time for dabigatran etexilate is about 4 min.

2. The liquid chromatographic procedure in the Dissolution test was validated using the Inertsil ODS-4 brand of column with L1 packing. The typical retention time for dabigatran etexilate is about 2.5 min.

3. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Kromasil 100-5-C18 brand of column with L1 packing. The typical retention time for dabigatran etexilate is about 50 min.

 USP is soliciting other approved applications with differing specifications for dabigatran etexilate related compound A.

 (SM6: T. Bililign)

 Case ID—SUB-290