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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

Acalabrutinib Nitroso Impurity 1

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Catalogue No.:	VE0026048
CAS No.:	N/A
Mol. Formula:	C22H20N8O2
Mol. Weight:	428.45 g/mol

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Additional information on

Parent drug

Acalabrutinib

IUPAC Name

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

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

O=C(NC1=NC=CC=C1)C2=CC=C(C3=C4C(N)=NC=CN4C([C@@H]5N(N=O)CCC5)=N3)C=C2

InChI

InChI=1S/C22H20N8O2/c23-20-19-18(27-21(29(19)13-11-25-20)16-4-3-12-30(16)28-32)14-6-8-15(9-7-14)22(31)26-17-5-1-2-10-24-17/h1-2,5-11,13,16H,3-4,12H2,(H2,23,25)(H,24,26,31)/t16-/m1/s1

Description

Acalabrutinib Nitroso Impurity 1 is a nitroso-derived process-related impurity observed in acalabrutinib synthesis and stability studies. Characterized by a nitroso functional group, this impurity forms via nitrosation of amine precursors or by reaction with residual nitrites under acidic conditions. It requires targeted identification and quantitation using sensitive techniques such as LC-MS/MS, HRMS and NMR for structural confirmation and UPLC for routine monitoring. Due to the known genotoxic potential of nitroso species, control strategies are necessary including minimization of nitrite sources, pH control, antioxidant exclusion and validated impurity limits in analytical methods consistent with ICH guidance. Stability and degradation pathways must be defined and documented.