Cisatracurium Besilate EP Impurity L Ditrifluoroacetate CAS CATO-C4X-185015

Purity >85%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-185015
Molecular FormulaC56H76N2O14
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cisatracurium Besilate EP Impurity L Ditrifluoroacetate CAS CATO-C4X-185015 chemical structure

Description

The occurrence of Cisatracurium Besilate EP Impurity L Ditrifluoroacetate is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Cisatracurium Besilate EP Impurity L Ditrifluoroacetate (CAS CATO-C4X-185015, C56H76N2O14C2F3O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Cisatracurium Besilate EP Impurity L Ditrifluoroacetate (C56H76N2O14C2F3O2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

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 FormulaC56H76N2O14 2*C2F3O2
Molecular Weight1114.24 g/mol
Purity>85%
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)20.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms2

Related Cisatracurium Standards

Recommended Standards

Why CATO?