Rosiglitazone Impurity 4 CAS CATO-C4X-21794

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-21794
Molecular FormulaC18H23N3O2
Molecular Weight313.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rosiglitazone Impurity 4 CAS CATO-C4X-21794 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 Rosiglitazone Impurity 4.

CATO supplies Rosiglitazone Impurity 4 (CAS CATO-C4X-21794), a pharmacopoeial impurity reference standard (molecular formula C18H23N3O2, MW 313.39 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Rosiglitazone Impurity 4 (C18H23N3O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 Rosiglitazone Impurity 4 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 FormulaC18H23N3O2
Molecular Weight313.39 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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