Paricalcitol Impurity 10 CAS CATO-C4X-138710

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Paricalcitol Impurity 10.

CATO supplies Paricalcitol Impurity 10 (CAS CATO-C4X-138710), a pharmacopoeial impurity reference standard (molecular formula C20H27O3P, MW 346.40 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C20H27O3P, Paricalcitol Impurity 10 contains a steroid core, a phosphonate group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 346.40 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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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