Thioctic acid Impurity 35 CAS 74903-53-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.74903-53-0
Molecular FormulaC8H16O4
Molecular Weight176.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Thioctic acid Impurity 35 CAS 74903-53-0 chemical structure

Description

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.

CATO supplies Thioctic acid Impurity 35 (CAS 74903-53-0), a pharmacopoeial impurity reference standard (molecular formula C8H16O4, MW 176.21 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, Thioctic acid Impurity 35 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 176.21 g/mol — guide the selection of appropriate sample preparation and analytical techniques.

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

Molecular FormulaC8H16O4
Molecular Weight176.21 g/mol
Purity>95%
StorageStore at 2-8°C, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1978

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