Drotaverine Impurity 13 CAS 69373-87-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.69373-87-1
Molecular FormulaC14H20O4
Molecular Weight252.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Drotaverine Impurity 13 CAS 69373-87-1 chemical structure

Description

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 supplies Drotaverine Impurity 13 (CAS 69373-87-1), a pharmacopoeial impurity reference standard (molecular formula C14H20O4, MW 252.31 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Drotaverine Impurity 13 (C14H20O4) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. 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.

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 FormulaC14H20O4
Molecular Weight252.31 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1976

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