Bendamustine Impurity 37 CAS CATO-C4X-127137

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-127137
Molecular FormulaC18H25N3O3
Molecular Weight331.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bendamustine Impurity 37 CAS CATO-C4X-127137 chemical structure

Description

The occurrence of Bendamustine Impurity 37 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Bendamustine Impurity 37 (CAS CATO-C4X-127137) is a certified pharmaceutical impurity reference standard with the molecular formula C18H25N3O3 and a molecular weight of 331.41 g/mol.

The molecular framework of Bendamustine Impurity 37 (C18H25N3O3) is characterized by a steroid core, 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).

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), Bendamustine Impurity 37 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 FormulaC18H25N3O3
Molecular Weight331.41 g/mol
AppearancePale yellow to yellow crystalline powder
Purity95%
StorageStore at 2-8°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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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