Ergocalciferol EP Impurity E CAS 115-61-7

Description

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

As a process- or degradation-related impurity, Ergocalciferol EP Impurity E (CAS 115-61-7, C28H44O) 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, Ergocalciferol EP Impurity E is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 396.65 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.

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

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