Lercanidipine Impurity 60 CAS 100427-51-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.100427-51-8
Molecular FormulaC24H31NO3
Molecular Weight381.51 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lercanidipine Impurity 60 CAS 100427-51-8 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 Lercanidipine Impurity 60.

CATO supplies Lercanidipine Impurity 60 (CAS 100427-51-8), a pharmacopoeial impurity reference standard (molecular formula C24H31NO3, MW 381.51 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Lercanidipine Impurity 60 (C24H31NO3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. 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 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.

CATO manufactures Lercanidipine Impurity 60 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.

Physical & Chemical Properties

Molecular FormulaC24H31NO3
Molecular Weight381.51 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
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
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1985
Nitrogen Atoms1

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