Calcitriol Impurity 60 CAS CATO-C4X-151060

Description

The occurrence of Calcitriol Impurity 60 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Calcitriol Impurity 60 (CAS CATO-C4X-151060), a pharmacopoeial impurity reference standard (molecular formula C45H86O3Si3, MW 759.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Calcitriol Impurity 60 (C45H86O3Si3) contains a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 759.42 g/mol, it falls into the high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Calcitriol Impurity 60 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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