Pregabalin Impurity 83 CAS 181289-25-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.181289-25-8
Molecular FormulaC10H18O4
Molecular Weight202.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 83 CAS 181289-25-8 chemical structure

Description

CATO supplies Pregabalin Impurity 83 (CAS 181289-25-8), a pharmacopoeial impurity reference standard (molecular formula C10H18O4, MW 202.25 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C10H18O4, Pregabalin Impurity 83 contains a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 202.25 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

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 FormulaC10H18O4
Molecular Weight202.25 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)2008

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