Ticagrelor

CAS number: 274693-27-5

Molecular formula: C23H28F2N6O4S

molecular weight: 522.574

Chemical structure:

ItemsSpecificationResults
AppearanceA  white  or    almost  white  to    light  pink  crystalline powderLight    pink  crystalline powder
SolubilityFreely  soluble  in    methanol,   practically  insoluble  in water.Conform
Qotical rotation-51 0   """"-54-54
IdentificationHPLC-RT should comply with the WSConform
IR spectrum should comply with the WSConform
Related substanceAImpurity TCG-DGA: not more than 0.15%0.01%
Impurity TCG-ISO: not more than 0.1 5%N.D
Impurity TCG-ACE : not more than 0.15%N .D
Impurity TCG-IPD : not more than 0.15%N.D
Impurity TCG-DET: not more than 0.15%0.04%
Impurity TCG-HDR: not more than 0.15%N.D
Impurity TCG心伍0:   not more than 0.15%N .D
Any other individual impurity: not more   than 0.10%0.04%
BImpurity TCG-CPA: not more than 8ppmN.D
CImpurity TCG-CSR: not more than 0.15%N .D
Total impurity(A and B and C ): not more   than 0.5%0.20%
Residue on ignitionNot more than 0.1 %0.00%
Loss on dryingNot more than 0.5%0.10%
Heavy metalNot more than 20ppmLess than 20ppm
Limit of chlorideNot more than 0.02%Less than 0.02%
Residual solventToluene: not more than 890ppm210ppm
Methanol: not more than 3000ppmN.D
Acetone: not more than 5000ppmN.D
Cyclohexane: not more than 3880ppmN.D
Assay   (As dry basis)98.0-102.0%100.30%