Thioctic Acid Impurity 51 CAS 56535-97-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.56535-97-8
Molecular FormulaC8H13ClO3
Molecular Weight192.64 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Thioctic Acid Impurity 51 CAS 56535-97-8 chemical structure

Description

As a certified reference material (CRM), Thioctic Acid Impurity 51 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.

As a process- or degradation-related impurity, Thioctic Acid Impurity 51 (CAS 56535-97-8, C8H13ClO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Thioctic Acid Impurity 51 (C8H13ClO3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. 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. 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.

Physical & Chemical Properties

Molecular FormulaC8H13ClO3
Molecular Weight192.64 g/mol
Purity>95%
StorageStore at 2-8°C, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1973
Halogen ContentCl-containing

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