Nateglinide EP Impurity C CAS CATO-C4X-13209

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-13209
Molecular FormulaC19H27NO3
Molecular Weight317.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nateglinide EP Impurity C CAS CATO-C4X-13209 chemical structure

Description

CATO manufactures Nateglinide EP Impurity C 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.

CATO supplies Nateglinide EP Impurity C (CAS CATO-C4X-13209), a pharmacopoeial impurity reference standard (molecular formula C19H27NO3, MW 317.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Nateglinide EP Impurity C is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 317.42 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 FormulaC19H27NO3
Molecular Weight317.42 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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