Pregnenolone Impurity 1 CAS 1162-53-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1162-53-4
Molecular FormulaC21H30O2
Molecular Weight314.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregnenolone Impurity 1 CAS 1162-53-4 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 314.46 g/mol gives Pregnenolone Impurity 1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Pregnenolone Impurity 1 (CAS 1162-53-4) is a certified pharmaceutical impurity reference standard with the molecular formula C21H30O2 and a molecular weight of 314.46 g/mol.

Structurally, Pregnenolone Impurity 1 (C21H30O2) contains a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 314.46 g/mol, it falls into the moderately-high-molecular-weight range. 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.

As a certified reference material (CRM), Pregnenolone Impurity 1 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 FormulaC21H30O2
Molecular Weight314.46 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
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.)1957

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