باب
Acalabrutinib
رقم CAS
NA
الصيغة الجزيئية
C₂₂H₂₀N₈O₂
وزن جزيئي
428.46 g/mol
مرادف

(S)-4-(8-Amino-3-(1-nitrosopyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide

الكلمات الرئيسية
Intermediates
Pharmaceutical Standards
Fine Chemicals
Nitrosamine Standards manufacturers and Suppliers in Hyderabad India
Impurities manufacturer and Suppliers in Hyderabad india
Slide_1
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.

Acalabrutinib Nitrosamine Impurity is a critical trace impurity monitored during the synthesis and quality control of Acalabrutinib due to its potential genotoxicity. Its detection and quantification are essential for ensuring regulatory compliance, drug safety, and the overall purity of the final pharmaceutical formulation.