Calcitriol Impurity 12 CAS CATO-C4X-151012

Description

The occurrence of Calcitriol Impurity 12 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Calcitriol Impurity 12 (CAS CATO-C4X-151012), a pharmacopoeial impurity reference standard (molecular formula C33H58O2Si, MW 514.90 g/mol) used for the identification and quantification of trace impurities in APIs.

Calcitriol Impurity 12 (C33H58O2Si) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 12 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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