Thioctic Acid EP Impurity B CAS 462-20-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.462-20-4
Molecular FormulaC8H16O2S2
Molecular Weight208.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Thioctic Acid EP Impurity B CAS 462-20-4 chemical structure

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 EP Impurity B.

CATO supplies Thioctic Acid EP Impurity B (CAS 462-20-4), a pharmacopoeial impurity reference standard (molecular formula C8H16O2S2, MW 208.34 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Thioctic Acid EP Impurity B (C8H16O2S2) is characterized by a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development.

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 EP Impurity B 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

Molecular FormulaC8H16O2S2
Molecular Weight208.34 g/mol
Purity>95%
StorageStore at room temperature
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1957
Sulfur Atoms2

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