Pregabalin Impurity 29 CAS 4228-66-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.4228-66-4
Molecular FormulaC9H8O5
Molecular Weight196.16 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 29 CAS 4228-66-4 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pregabalin Impurity 29.

CATO supplies Pregabalin Impurity 29 (CAS 4228-66-4), a pharmacopoeial impurity reference standard (molecular formula C9H8O5, MW 196.16 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pregabalin Impurity 29 (C9H8O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 196.16 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

CATO manufactures Pregabalin Impurity 29 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC9H8O5
Molecular Weight196.16 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958

Related Pregabalin Standards

Recommended Standards

Why CATO?