Mexiletine Impurity 2 CAS 29361-43-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.29361-43-1
Molecular FormulaC11H17NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mexiletine Impurity 2 CAS 29361-43-1 chemical structure

Description

CATO manufactures Mexiletine Impurity 2 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

CATO supplies Mexiletine Impurity 2 (CAS 29361-43-1), a pharmacopoeial impurity reference standard (molecular formula C11H17NOHCl, MW 215.72 g/mol) used for the identification and quantification of trace impurities in APIs.

Mexiletine Impurity 2 (C11H17NOHCl) contains an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

Physical & Chemical Properties

Molecular FormulaC11H17NO HCl
Molecular Weight215.72 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
CAS Registry Year (est.)1965
Halogen ContentCl-containing
Nitrogen Atoms1

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