Venetoclax Impurity 54 CAS CATO-C4X-249554

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-249554
Molecular FormulaC39H40ClN7O6S
Molecular Weight770.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Venetoclax Impurity 54 CAS CATO-C4X-249554 chemical structure

Description

As a process- or degradation-related impurity, Venetoclax Impurity 54 (CAS CATO-C4X-249554, C39H40ClN7O6S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Venetoclax Impurity 54 (C39H40ClN7O6S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

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 FormulaC39H40ClN7O6S
Molecular Weight770.30 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)23.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms7
Sulfur Atoms1

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