Pregabalin Impurity 128 CAS CATO-C4X-1312128

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1312128
Molecular FormulaC10H18O3
Molecular Weight186.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 128 CAS CATO-C4X-1312128 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.

As a process- or degradation-related impurity, Pregabalin Impurity 128 (CAS CATO-C4X-1312128, C10H18O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Pregabalin Impurity 128 (C10H18O3) contains a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC10H18O3
Molecular Weight186.25 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)2.0

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