Mianserin lmpurity 31 HCl CAS CATO-C4X-136931

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-136931
Molecular FormulaC11H16ClNO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mianserin lmpurity 31 HCl CAS CATO-C4X-136931 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 Mianserin lmpurity 31 HCl.

CATO supplies Mianserin lmpurity 31 HCl (CAS CATO-C4X-136931), a pharmacopoeial impurity reference standard (molecular formula C11H16ClNOHCl, MW 250.16 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Mianserin lmpurity 31 HCl (C11H16ClNOHCl) is characterized by 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. 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 FormulaC11H16ClNO HCl
Molecular Weight250.16 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
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 Atoms1

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