Testosterone Impurity 35 CAS CATO-C4X-243235

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-243235
Molecular FormulaC26H38O3
Molecular Weight398.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Testosterone Impurity 35 CAS CATO-C4X-243235 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 Testosterone Impurity 35.

Testosterone Impurity 35 (CAS CATO-C4X-243235) is a certified pharmaceutical impurity reference standard with the molecular formula C26H38O3 and a molecular weight of 398.58 g/mol.

The molecular framework of Testosterone Impurity 35 (C26H38O3) is characterized by a steroid core, 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.

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 FormulaC26H38O3
Molecular Weight398.58 g/mol
AppearancePale yellow to yellow crystalline powder
Purity95%
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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