Epinastine Impurity 38 CAS CATO-C4X-184038

Description

The occurrence of Epinastine Impurity 38 is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Epinastine Impurity 38 (CAS CATO-C4X-184038), a pharmacopoeial impurity reference standard (molecular formula C30H24N4O2S2, MW 536.67 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Epinastine Impurity 38 (C30H24N4O2S2) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 21.0, corresponding to approximately 21 ring(s) or double-bond equivalent(s). With a molecular weight of 536.67 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Epinastine Impurity 38 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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