Clemastine Impurity 6 Fumarate (S,S-isomer) CAS 61826-29-7

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Clemastine Impurity 6 Fumarate (S,S-isomer).

CATO supplies Clemastine Impurity 6 Fumarate (S,S-isomer) (CAS 61826-29-7), a pharmacopoeial impurity reference standard (molecular formula C21H26ClNOC4H4O4, MW 459.97 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Clemastine Impurity 6 Fumarate (S,S-isomer) (C21H26ClNOC4H4O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 459.97 g/mol, it falls into the moderately-high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Clemastine Impurity 6 Fumarate (S,S-isomer) under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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