Propafenone EP Impurity B HCl CAS 88308-22-9 (free base)

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.88308-22-9 (free base)
Molecular FormulaC21H25NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Propafenone EP Impurity B HCl CAS 88308-22-9 (free base) 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 Propafenone EP Impurity B HCl.

CATO supplies Propafenone EP Impurity B HCl (CAS 88308-22-9 (free base)), a pharmacopoeial impurity reference standard (molecular formula C21H25NO3HCl, MW 375.89 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Propafenone EP Impurity B HCl (C21H25NO3HCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 375.89 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Propafenone EP Impurity B HCl 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 FormulaC21H25NO3 HCl
Molecular Weight375.89 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>90%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

Related Propafenone Standards

Recommended Standards

Why CATO?