Eldecalcitol Impurity 41 CAS 214351-92-5

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 41.

CATO supplies Eldecalcitol Impurity 41 (CAS 214351-92-5), a pharmacopoeial impurity reference standard (molecular formula C18H34O2, MW 282.46 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Eldecalcitol Impurity 41 (C18H34O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 282.46 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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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