Benzydamine EP Impurity B HCl CAS 2196183-71-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2196183-71-6
Molecular FormulaC26H29N3O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Benzydamine EP Impurity B HCl CAS 2196183-71-6 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Benzydamine EP Impurity B HCl.

CATO supplies Benzydamine EP Impurity B HCl (CAS 2196183-71-6), a pharmacopoeial impurity reference standard (molecular formula C26H29N3OHCl, MW 436.00 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Benzydamine EP Impurity B HCl (C26H29N3OHCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), 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).

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 FormulaC26H29N3O HCl
Molecular Weight436.00 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1998
Halogen ContentCl-containing
Nitrogen Atoms3

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