BRIEFING

 Tofacitinib Extended-Release Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.

1. The liquid chromatographic procedure in Identification C was validated using the Chiralpak ID brand of column with L126 packing. The typical retention time for tofacitinib related compound B is about 13 min.

2. The liquid chromatographic procedure in the Assay was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for tofacitinib is about 3 min.

3. The liquid chromatographic procedure in the Dissolution test was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for tofacitinib is about 5 min.

4. The liquid chromatographic procedure in the Organic Impurities test was validated using the Kromasil 100-5-C18 brand of column with L1 packing. The typical retention time for tofacitinib is about 12 min.

5. The liquid chromatographic procedure in the Limit of Cyanoacetic Acid test was validated using the Dionex IonPac AS11-HC brand of analytical column with L81 packing. The typical retention time for cyanoacetic acid is about 7 min.

 (SM2: M. Fadadu)

 Case ID—SUB-1782