Thioctic acid Impurity 42 CAS 90435-60-2

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 42.

CATO supplies Thioctic acid Impurity 42 (CAS 90435-60-2), a pharmacopoeial impurity reference standard (molecular formula C8H15ClO3, MW 194.66 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C8H15ClO3, Thioctic acid Impurity 42 contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 194.66 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

As a certified reference material (CRM), Thioctic acid Impurity 42 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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