Calcifediol Monohydrate EP Impurity A CAS 61585-29-3

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Calcifediol Monohydrate EP Impurity A.

As a process- or degradation-related impurity, Calcifediol Monohydrate EP Impurity A (CAS 61585-29-3, C27H44O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, a hydroxyl group, an ether linkage, Calcifediol Monohydrate EP Impurity A is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 400.64 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Calcifediol Monohydrate EP Impurity A 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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