BRIEFING
Theophylline 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 is based on validation performed with the Acclaim 120 C18 brand of column with L1 packing. The typical retention time for theophylline is about 5 min.
-
The liquid chromatographic procedure in Dissolution, Test 1 is based on validation performed with the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for theophylline is about 3 min.
-
The liquid chromatographic procedure in the test for Organic Impurities is based on validation performed with the Acclaim 120 C8 brand of column with L7 packing. The typical retention time for theophylline is about 30 min.
(SM5: D. Singh)
Case ID—SUB-1064, SUB-1269