Thioctic acid Impurity 5 CAS 3206-73-3

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Thioctic acid Impurity 5.

CATO supplies Thioctic acid Impurity 5 (CAS 3206-73-3), a pharmacopoeial impurity reference standard (molecular formula C8H15NOS2, MW 205.34 g/mol) used for the identification and quantification of trace impurities in APIs.

Thioctic acid Impurity 5 (C8H15NOS2) contains an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage. Its physicochemical properties are representative of its class; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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