Norethisterone EP Impurity E CAS 79727-03-0

Description

The occurrence of Norethisterone EP Impurity E is closely related to a steroid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Norethisterone EP Impurity E (CAS 79727-03-0), a pharmacopoeial impurity reference standard (molecular formula C22H26O, MW 306.44 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, a hydroxyl group, an ether linkage, Norethisterone EP Impurity E is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 306.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 Norethisterone EP Impurity E 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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