Vinorelbine EP Impurity I CAS CATO-C4X-264210

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-264210
Molecular FormulaC45H53BrN4O8
Molecular Weight857.83 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Vinorelbine EP Impurity I CAS CATO-C4X-264210 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 Vinorelbine EP Impurity I.

As a process- or degradation-related impurity, Vinorelbine EP Impurity I (CAS CATO-C4X-264210, C45H53BrN4O8) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Vinorelbine EP Impurity I (C45H53BrN4O8) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution. 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Vinorelbine EP Impurity I 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.

Physical & Chemical Properties

Molecular FormulaC45H53BrN4O8
Molecular Weight857.83 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)21.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms4

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