Pregabalin Impurity 75 CAS CATO-C4X-131275

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-131275
Molecular FormulaC9H15NO3
Molecular Weight185.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 75 CAS CATO-C4X-131275 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 75.

Pregabalin Impurity 75 (CAS CATO-C4X-131275) is a certified pharmaceutical impurity reference standard with the molecular formula C9H15NO3 and a molecular weight of 185.22 g/mol.

Structurally, Pregabalin Impurity 75 (C9H15NO3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 185.22 g/mol, it falls into the medium-molecular-weight range. 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.

CATO manufactures Pregabalin Impurity 75 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 FormulaC9H15NO3
Molecular Weight185.22 g/mol
AppearanceWhite to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
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)3.0
UV AbsorptionUV-absorbing
Nitrogen Atoms1

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