BRIEFING
Pramipexole Dihydrochloride 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.
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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 pramipexole is about 5 min.
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The liquid chromatographic analytical procedure in Dissolution Test 1 was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for pramipexole is about 4 min.
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The liquid chromatographic analytical procedure in Dissolution Test 2 was validated using the ACE C18 brand of column with L1 packing. The typical retention time for pramipexole is about 6 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for pramipexole is about 38 min.
(SM4: R. Nguyen)
Correspondence Number—C196168; C305588