Category
Acalabrutinib
CAS Number
NA
Molecular Formula
C₂₆H₂₂N₆O₃
Molecular Weight
466.5 g/mol
Synonym

(S)-4-(3-(1-(but-2-ynoyl)pyrrolidin-2-yl)-8-hydroxyimidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide ; 

Keywords
Intermediates
Pharmaceutical Standards
Fine Chemicals
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 8-Hydroxy Impurity is a specialized reference material used in the pharmaceutical industry for the analysis of acalabrutinib drug substances and formulations. With a molecular formula of C₂₆H₂₂N₆O₃ and a molecular weight of 466.5 g/mol, this impurity plays a critical role in impurity profiling, stability studies, and analytical method development. The CAS number is currently not available (NA). It is widely applied in quality control processes to ensure the purity, safety, and consistency of pharmaceutical products. The compound is compatible with advanced analytical techniques such as HPLC, LC-MS/MS, and NMR, enabling accurate identification and quantification. Its use supports pharmaceutical manufacturers in meeting stringent regulatory requirements, including USP, EP, ICH, and FDA guidelines, thereby ensuring high-quality and compliant drug formulations.

Acalabrutinib is manufactured and supplied by Manasa Life Sciences in Hyderabad, India, with a strong emphasis on quality, precision, and regulatory compliance. The company delivers high-purity acalabrutinib standards and related impurities to pharmaceutical markets across Asia, Europe, Africa, the GCC, and the UAE, ensuring reliable supply, complete traceability, and strict adherence to Good Documentation Practices (GDP).