Catégorie
Prasugrel
Numéro CAS
Prasugrel STD-150322-43-3; 389574-19-0(HCl Salt): IMP-B-1391194-39-0: IMP-E-1056459-37-0; 1618107-96-2(HCl Salt);1373350-61-8(maleate salt)
Formule moléculaire
Prasugrel STD-C20H20FNO3S: IMP-B-C20H20FNO3S: IMP-E-C20H21ClFNO3S
Masse moléculaire
Prasugrel STD-373.44: IMP-B-373.44: IMP-E-409.90
Synonyme

Prasugrel STD-[5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate; 5-(2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate (USP) 

Prasugrel-EP-Impurity-B-[5-[2-cyclopropyl-1-(3-fluorophenyl)-2-oxoethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate

Prasugrel-EP-Impurity-E-[5-[5-chloro-1-(2-fluorophenyl)-2-oxopentyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Prasugrel for system suitability CRS is a standardized reference material used to verify that an analytical method typically in chromatographic assays is performing correctly before testing actual samples. It helps confirm parameters like resolution, peak shape, retention time, and sensitivity, ensuring the system is accurate, precise, and compliant with pharmacopeial requirements.