BRIEFING
Pramipexole Dihydrochloride Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. Based on comments received, the proposal in PF 44(1) has been canceled and is being replaced with a new proposal.
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The liquid chromatographic procedures in the Assay and Dissolution Test 1 were validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for pramipexole is about 3 min.
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The liquid chromatographic procedure in Dissolution Test 2 was validated using the ZORBAX Eclipse XDB-C8 brand of column with L7 packing. The typical retention time for pramipexole is about 7 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Kromasil C18 brand of column with L1 packing. The typical retention time for pramipexole is about 35 min.
Stakeholders are encouraged to submit their FDA-approved specifications, if different from the proposed ones, to USP for consideration.
(SM4: S. Singireddy)
Case ID—SUB-1259, SUB-1795, SUB-1810