Pregabalin Impurity 2 CAS 75143-89-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.75143-89-4
Molecular FormulaC9H16O4
Molecular Weight188.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 2 CAS 75143-89-4 chemical structure

Description

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.

CATO supplies Pregabalin Impurity 2 (CAS 75143-89-4), a pharmacopoeial impurity reference standard (molecular formula C9H16O4, MW 188.22 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pregabalin Impurity 2 (C9H16O4) contains a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 188.22 g/mol, it falls into the medium-molecular-weight range.

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 FormulaC9H16O4
Molecular Weight188.22 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
CAS Registry Year (est.)1978

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