BRIEFING
Palonosetron Injection. 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 46(5) has been canceled and is being replaced with a new proposal.
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The liquid chromatographic procedure in the Assay was validated using the Kromasil C4 brand of column with L26 packing. The typical retention time for palonosetron is about 7 min.
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The liquid chromatographic procedure in the test for Limit of Palonosetron Related Compound B was validated using the Kromasil C4 brand of column with L26 packing. The typical retention time for palonosetron related compound B is about 8 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the YMC-Pack Pro C4 brand of column with L26 packing. The typical retention time for palonosetron is about 12 min.
(SM3: D. Singh)
Case ID—SUB-1144