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New Jersey, USA
Czech Republic, EU
Mumbai, India

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Acalabrutinib Nitroso Impurity 5

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Katalog-Nr.::	VE0026049
CAS-Nr.::	N/A
Summenformel::	C10H10ClN5O
Molare Masse::	251.67 g/mol

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Zusätzliche Informationen zu

Parent drug

Acalabrutinib

IUPAC-Name

(S)-8-chloro-3-(1-nitrosopyrrolidin-2-yl)imidazo[1,5-a]pyrazine

SMILES

O=NN(CCC1)[C@@H]1C2=NC=C3N2C=CN=C3Cl

InChI

InChI=1S/C10H10ClN5O/c11-9-8-6-13-10(15(8)5-3-12-9)7-2-1-4-16(7)14-17/h3,5-7H,1-2,4H2/t7-/m0/s1

Beschreibung

Acalabrutinib Nitroso Impurity 5 is a nitroso-derived degradation product identified during forced-degradation and stability studies of acalabrutinib. This impurity arises via oxidative transformation of the corresponding amine under nitrosating or oxidative conditions and can impact active pharmaceutical ingredient purity and stability profiles. Analytical characterization uses orthogonal techniques including HPLC with UV detection, LC-MS/MS for accurate mass confirmation, and NMR for structural elucidation. Control strategies focus on preventing nitrosation precursors, adjusting formulation pH, antioxidant inclusion and validated in-process controls. Given potential genotoxic concern associated with nitroso functionalities, specification setting, routine monitoring and validated limit tests in accordance with ICH impurity guidelines are essential.