Eldecalcitol Impurity 76 CAS CATO-C4X-214076

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-214076
Molecular FormulaC27H42O3
Molecular Weight414.62 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Eldecalcitol Impurity 76 CAS CATO-C4X-214076 chemical structure

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 76.

CATO supplies Eldecalcitol Impurity 76 (CAS CATO-C4X-214076), a pharmacopoeial impurity reference standard (molecular formula C27H42O3, MW 414.62 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Eldecalcitol Impurity 76 (C27H42O3) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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

Molecular FormulaC27H42O3
Molecular Weight414.62 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity≥95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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