Paliperidone Impurity 37 CAS 4403-49-0

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Paliperidone Impurity 37.

CATO supplies Paliperidone Impurity 37 (CAS 4403-49-0), a pharmacopoeial impurity reference standard (molecular formula C2H7NO3S, MW 125.15 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Paliperidone Impurity 37 (C2H7NO3S) contains an amide group, a sulfone group, a carboxylic acid group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 0.0, corresponding to approximately 0 ring(s) or double-bond equivalent(s). With a molecular weight of 125.15 g/mol, it falls into the low-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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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