Bendamustine Impurity 28 HCl CAS CATO-C4X-127128

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-127128
Molecular FormulaC7H11N3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bendamustine Impurity 28 HCl CAS CATO-C4X-127128 chemical structure

Description

The occurrence of Bendamustine Impurity 28 HCl is closely related to a nitrile group, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Bendamustine Impurity 28 HCl (CAS CATO-C4X-127128, C7H11N3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Bendamustine Impurity 28 HCl (C7H11N3HCl) is characterized by a nitrile group, chlorine 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC7H11N3 HCl
Molecular Weight173.64 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
Halogen ContentCl-containing
Nitrogen Atoms3

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