BRIEFING
Pregabalin Extended-Release Tablets. 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 procedure in the Assay was validated using the Atlantis T3 brand of column with L1 packing. The typical retention time for pregabalin is about 8.9 min.
-
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 pregabalin is about 6.7 min.
-
The liquid chromatographic procedure in the test for Organic Impurities was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention times for pregabalin and pregabalin related compound C are about 8 and 30 min, respectively.
(SM2: F. Gu)
Case ID—SUB-1260