Desogestrel EP Impurity A/Desogestrel USP RC A CAS 201360-82-9

Description

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

CATO supplies Desogestrel EP Impurity A/Desogestrel USP RC A (CAS 201360-82-9), a pharmacopoeial impurity reference standard (molecular formula C22H30O, MW 310.47 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Desogestrel EP Impurity A/Desogestrel USP RC A (C22H30O) contains a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 310.47 g/mol, it falls into the moderately-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.

CATO manufactures Desogestrel EP Impurity A/Desogestrel USP RC A 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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