Pregabalin Impurity 140 CAS CATO-C4X-1312140

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1312140
Molecular FormulaC16H26N2O
Molecular Weight262.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 140 CAS CATO-C4X-1312140 chemical structure

Description

CATO supplies Pregabalin Impurity 140 (CAS CATO-C4X-1312140), a pharmacopoeial impurity reference standard (molecular formula C16H26N2O, MW 262.39 g/mol) used for the identification and quantification of trace impurities in APIs.

Pregabalin Impurity 140 (C16H26N2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; 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.

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), Pregabalin Impurity 140 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 FormulaC16H26N2O
Molecular Weight262.39 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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