Category
Zanubrutinib
CAS Number
NA
Molecular Formula
C₂₇H₃₁N₅O₄
Molecular Weight
489.58 g/mol
Synonym

(S)-3-(4-(3-Carbamoyl-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidin-7-yl)piperidin-1-yl)propanoic Acid; 3-(4-(3-Carbamoyl-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidin-7-yl)piperidin-1-yl)propanoic acid ; Zanubrutinib Amino Acid Impurity

Keywords
Intermediates
Impurities
Metabolites.
Pharmaceutical Standards
Fine Chemicals
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.

Zanubrutinib Amino Acid Impurity is a process-related impurity associated with the manufacture of Zanubrutinib, typically arising from starting materials, intermediates, or side reactions involving amino acid–derived fragments during synthesis. It is monitored in pharmaceutical quality control to ensure the drug’s purity, safety, and compliance with regulatory limits for related substances.