BRIEFING
Carbidopa Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this drug product that appeared in PF 46(4) [Jul.–Aug. 2020] has been canceled and is being replaced with this new proposal.
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The liquid chromatographic procedures in the Assay and the test for Dissolution were validated using the Purospher Star RP-18e brand of column with L1 packing. The typical retention time for carbidopa is about 8 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the YMC-Pack ODS-A brand of column with L1 packing. The typical retention time for carbidopa is about 6 min.
(SM4: D. Singh)
Case ID—SUB-1415