Calcifediol Impurity 8 CAS 78782-98-6

Description

Compared with other compounds in its class, the molecular weight of 406.67 g/mol gives Calcifediol Impurity 8 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Calcifediol Impurity 8 (CAS 78782-98-6), a pharmacopoeial impurity reference standard (molecular formula C27H38D6O2, MW 406.67 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Calcifediol Impurity 8 (C27H38D6O2) contains deuterium isotope labeling, a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 406.67 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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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