Dimefline Impurity 11 CAS CATO-C4X-335111

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-335111
Molecular FormulaC21H24NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dimefline Impurity 11 CAS CATO-C4X-335111 chemical structure

Description

CATO manufactures Dimefline Impurity 11 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 Dimefline Impurity 11 (CAS CATO-C4X-335111), a pharmacopoeial impurity reference standard (molecular formula C21H24NO3Cl, MW 373.88 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C21H24NO3Cl, Dimefline Impurity 11 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 373.88 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

Physical & Chemical Properties

Molecular FormulaC21H24NO3 Cl
Molecular Weight373.88 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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