Thioctic acid Impurity 81 CAS CATO-C4X-152681

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-152681
Molecular FormulaC12H22Cl2O2
Molecular Weight269.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Thioctic acid Impurity 81 CAS CATO-C4X-152681 chemical structure

Description

CATO supplies Thioctic acid Impurity 81 (CAS CATO-C4X-152681), a pharmacopoeial impurity reference standard (molecular formula C12H22Cl2O2, MW 269.21 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, chlorine substitution, Thioctic acid Impurity 81 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 269.21 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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 FormulaC12H22Cl2O2
Molecular Weight269.21 g/mol
Purity≥95%
StorageStore at room temperature, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityContains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)1.0
Halogen ContentCl-containing

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