Testosterone Isocaproate EP Impurity E CAS 10312-45-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.10312-45-5
Molecular FormulaC25H38O3
Molecular Weight386.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Testosterone Isocaproate EP Impurity E CAS 10312-45-5 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 Testosterone Isocaproate EP Impurity E (CAS 10312-45-5), a pharmacopoeial impurity reference standard (molecular formula C25H38O3, MW 386.57 g/mol) used for the identification and quantification of trace impurities in APIs.

Testosterone Isocaproate EP Impurity E (C25H38O3) contains a steroid core, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; 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.

As a certified reference material (CRM), Testosterone Isocaproate EP Impurity E meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC25H38O3
Molecular Weight386.57 g/mol
AppearanceOff-white to pale yellow crystalline powder
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
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1959

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