Vinorelbine Impurity C CAS CATO-C4X-26424

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-26424
Molecular FormulaC45H54N4O8
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Vinorelbine Impurity C CAS CATO-C4X-26424 chemical structure

Description

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 supplies Vinorelbine Impurity C (CAS CATO-C4X-26424), a pharmacopoeial impurity reference standard (molecular formula C45H54N4O8CH2O2, MW 824.97 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Vinorelbine Impurity C (C45H54N4O8CH2O2) is characterized by a nitrogen-containing heterocyclic scaffold, 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).

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC45H54N4O8 CH2O2
Molecular Weight824.97 g/mol
Purity>95%
StorageStore in a cool place (≤25°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)21.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4

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