Eldecalcitol Impurity 63 CAS CATO-C4X-214063

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Eldecalcitol Impurity 63.

CATO supplies Eldecalcitol Impurity 63 (CAS CATO-C4X-214063), a pharmacopoeial impurity reference standard (molecular formula C22H27O4P, MW 386.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, a phosphate ester group, a hydroxyl group, an ether linkage, Eldecalcitol Impurity 63 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 386.42 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 Eldecalcitol Impurity 63 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

Why CATO?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
• 130,000+ catalog items in stock, COA supplied with every batch
• Worldwide shipping with full export documentation (HS code guidance available)
• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com