Pregabalin Impurity 137 CAS CATO-C4X-1312137

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1312137
Molecular FormulaC24H42N2O4
Molecular Weight422.60 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 137 CAS CATO-C4X-1312137 chemical structure

Description

As a certified reference material (CRM), Pregabalin Impurity 137 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.

CATO supplies Pregabalin Impurity 137 (CAS CATO-C4X-1312137), a pharmacopoeial impurity reference standard (molecular formula C24H42N2O4, MW 422.60 g/mol) used for the identification and quantification of trace impurities in APIs.

Pregabalin Impurity 137 (C24H42N2O4) contains a steroid core, an amide 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC24H42N2O4
Molecular Weight422.60 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity≥95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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