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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 2

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Catalogue No.:	VE0023820
CAS No.:	N/A
Mol. Formula:	C17H16N6O3
Mol. Weight:	352.35 g/mol

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Additional information on (S)-4-(8-amino-3-(1-nitrosopyrrolidin-2-yl)imidazo[1 | 5-a]pyrazin-1-yl)benzoic acid

Parent drug

Acalabrutinib

IUPAC Name

(S)-4-(8-amino-3-(1-nitrosopyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)benzoic acid

Smiles

O=C(O)C1=CC=C(C2=C3C(N)=NC=CN3C([C@H]4N(N=O)CCC4)=N2)C=C1

InChI

InChI=1S/C17H16N6O3/c18-15-14-13(10-3-5-11(6-4-10)17(24)25)20-16(22(14)9-7-19-15)12-2-1-8-23(12)21-26/h3-7,9,12H,1-2,8H2,(H2,18,19)(H,24,25)/t12-/m0/s1

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Description

Acalabrutinib Nitroso Impurity 2 ((S)-4-(8-amino-3-(1-nitrosopyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)benzoic acid) is a nitroso-bearing degradation product characterized by a nitrosopyrrolidinyl moiety adjacent to an imidazo[1,5-a]pyrazine core and a benzoic acid terminus, features that affect polarity, retention behavior and stereochemical complexity. Accurate detection and quantification are achieved using LC-MS, HPLC-UV and NMR fingerprinting for impurity profiling and stability studies. The presence of a nitroso functional group necessitates genotoxicity-focused risk evaluation and conservative specification limits. Comprehensive knowledge of formation pathways and targeted analytical controls supports impurity monitoring, specification setting and regulatory compliance within pharmaceutical quality systems.