BRIEFING
Ticagrelor Tablets. Because there is no existing monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this drug product which appeared in PF 45(5) [Sep.–Oct. 2019] was canceled and is replaced with a new proposal:
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The liquid chromatographic procedure in the Assay was validated using the Zorbax SB-C18 brand of column with L1 packing. The typical retention time for ticagrelor is about 4 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Zorbax SB-C18 brand of column with L1 packing. The typical retention time for ticagrelor is about 13 min.
(SM2: S. Shivaprasad)
Case ID—SUB-1405