Dorzagliatin Impurity 12 CAS CATO-C4X-344112

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-344112
Molecular FormulaC8H14O4
Molecular Weight174.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dorzagliatin Impurity 12 CAS CATO-C4X-344112 chemical structure

Description

Dorzagliatin Impurity 12 (CAS CATO-C4X-344112) is a certified pharmaceutical impurity reference standard with the molecular formula C8H14O4 and a molecular weight of 174.19 g/mol.

Dorzagliatin Impurity 12 (C8H14O4) contains a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions.

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), Dorzagliatin Impurity 12 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 FormulaC8H14O4
Molecular Weight174.19 g/mol
Purity97%+
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)2.0

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