Product name | Ticagrelor |
CAS No. | 274693-27-5 |
Molecular Formula | C23H28F2N6O4S |
Molecular Weight | 522.576 |
Quality Standard | 99% up by HPLC |
Appearance | White to off-white powder |
ITEMS | SPECIFICATION | RESULTS |
Appearance | White to off-white powder | Conforms |
Optical rotation | -50。~ 60。 | -53。 |
Identification | IR | Conforms |
HPLC | Conforms |
Isomers | TGD1≤0.15% | Undetected |
TGD2≤0.15% | Undetected |
TGE≤0.15% | Undetected |
TG-16≤0.15% | Undetected |
Related substance | De-ethoxyl of TG ≤ 0.15% | 0.01% |
Any single impurity ≤ 0.1% | 0.05% |
Total impurities ≤ 1.0% | 0.10% |
Residue on ignition | ≤ 0.1% | 0.08% |
Loss on drying | ≤ 0.5% | 0.14% |
Residual solvent | Ethyl ether <5000ppm Acetone<5000ppm Dichloromethane <600ppm Ethyl acetate <5000ppm Triethylamine <320ppm Toluene<890ppm Tetrahydrofuran <720ppm Methanol<3000ppm Ethanol<5000ppm Acetonitrile<4 10ppm hexane <290ppm N-methyl pyrrolidone<530ppm | Undetected Undetected Undetected 73 ppm Undetected Undetected Undetected Undetected Undetected Undetected Undetected Undetected |
Assay | 99%-102% | 100.5% |
Conclusion | The result conforms to the enterprise standards. |
Function of Ticagrelor
Today, with the continuous increase of acute coronary syndrome (ACS), antiplatelet therapy is still one of the important treatment measures for ACS. Ticagrelor is a novel cyclopentyltriazole pyrimidine (CPTP) oral antiplatelet drug with ATC code B01AC24. Ticagrelor is a non-prodrug that can act directly without hepatic metabolic activation, and binds reversibly to the P2Y12 ADP receptor. The results of the PLATO study showed that ticagrelor treatment for 12 months, without increasing major bleeding, further significantly reduced the risk of cardiovascular death/myocardial infarction/stroke composite endpoint events in ACS patients by 16%, and significantly Reduce cardiovascular death by 21%. The clinical efficacy and safety of ticagrelor have been validated and supported by the Platelet Inhibition and Patient Outcomes Outcomes Study (PLATO Study) and its multiple subgroups. Based on the benefits of ticagrelor treatment for ACS patients, guidelines in many countries state that ticagrelor is listed as the first-line recommendation. In the two authoritative guidelines of the European Society of Cardiology (ESC NSTE-ACS guidelines in 2011 and STEMI guidelines in 2012), it is pointed out that the use of clopidogrel in patients who cannot receive ticagrelor therapy is sufficient. Shows approval for the new drug to further reduce mortality.
