Ergocalciferol EP Impurity D CAS 469-06-7

Description

Compared with other compounds in its class, the molecular weight of 396.65 g/mol gives Ergocalciferol EP Impurity D distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Ergocalciferol EP Impurity D (CAS 469-06-7), a pharmacopoeial impurity reference standard (molecular formula C28H44O, MW 396.65 g/mol) used for the identification and quantification of trace impurities in APIs.

Ergocalciferol EP Impurity D (C28H44O) contains a steroid core, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

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