Bendamustine Impurity 31 CAS CATO-C4X-127131

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-127131
Molecular FormulaC19H27Cl2N3O3S
Molecular Weight448.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bendamustine Impurity 31 CAS CATO-C4X-127131 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 448.41 g/mol gives Bendamustine Impurity 31 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Bendamustine Impurity 31 (CAS CATO-C4X-127131, C19H27Cl2N3O3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Bendamustine Impurity 31 (C19H27Cl2N3O3S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 448.41 g/mol, it falls into the moderately-high-molecular-weight range. 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.

As a certified reference material (CRM), Bendamustine Impurity 31 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 FormulaC19H27Cl2N3O3S
Molecular Weight448.41 g/mol
Purity97%+
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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3
Sulfur Atoms1

Related Bendamustine Standards

Recommended Standards

Why CATO?