Nintedanib Impurity 89 CAS CATO-C4X-181489

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-181489
Molecular FormulaC16H15NO6
Molecular Weight317.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nintedanib Impurity 89 CAS CATO-C4X-181489 chemical structure

Description

As a certified reference material (CRM), Nintedanib Impurity 89 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

CATO supplies Nintedanib Impurity 89 (CAS CATO-C4X-181489), a pharmacopoeial impurity reference standard (molecular formula C16H15NO6, MW 317.29 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Nintedanib Impurity 89 (C16H15NO6) is characterized by a flavonoid 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 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 FormulaC16H15NO6
Molecular Weight317.29 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 methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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