1,2-Cyclopentanediol, 3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)-, (1S,2S,3R,5S)-;
(1S,2S,3R,5S)-3-{7-[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropylamino]-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl}-5-(2-hydroxyethoxy)cyclopentane-1,2-diol [274693-27-5]
BRIEFING
Ticagrelor. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal for this drug substance which appeared in PF 44(6) [Nov.–Dec. 2018] was canceled and is replaced with a new proposal.
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The chromatographic procedure in the Assay was validated using the ACE Phenyl brand of column with L11 packing. The typical retention time for ticagrelor is about 6 min.
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The chromatographic procedure in the test for Limit of Ticagrelor Related Compound A was validated using the Zorbax SB-C18 brand of column with L1 packing. The typical retention time for ticagrelor related compound A is about 6 min.
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The chromatographic procedure in the test for Organic Impurities, Procedure 1 was validated using the ACE Phenyl brand of column with L11 packing. The typical retention time for ticagrelor is about 23 min.
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The chromatographic procedure in the test for Organic Impurities, Procedure 2 was validated using the Lux Cellulose-2 brand of chiral column with L123 packing. The typical retention time for ticagrelor is about 26 min.
Description and solubility information: White or off-white to pale pink powder. Freely soluble in methanol; soluble in ethanol; very slightly soluble to practically insoluble in water.
(SM2: S. Shivaprasad)
Case ID—SUB-1384