Darunavir Impurity N20 CAS 244634-31-9

Description

The occurrence of Darunavir Impurity N20 is closely related to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Darunavir Impurity N20 (CAS 244634-31-9), a pharmacopoeial impurity reference standard (molecular formula C20H27N3O5SHCl, MW 457.97 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Darunavir Impurity N20 (C20H27N3O5SHCl) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 457.97 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Darunavir Impurity N20 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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