BRIEFING
Pregabalin Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. The proposal for this drug product which appeared in PF 44(5) was canceled and is replaced with a new proposal.
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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 pregabalin is about 4 min.
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The liquid chromatographic procedure in the Dissolution test was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for pregabalin is about 4 min.
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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 time for pregabalin is about 10 min.
(SM2: F. Gu)
Case ID—SUB-1020, SUB-1509, SUB-1518