Category
Acalabrutinib
CAS Number
NA
Molecular Formula
C₂₂H₂₀N₈O₂
Molecular Weight
428.46 g/mol
Synonym

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

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

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.