Isotretinoin EP Impurity I CAS 75281-25-3

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.75281-25-3
Molecular FormulaC20H28O3
Molecular Weight316.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Isotretinoin EP Impurity I CAS 75281-25-3 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 316.43 g/mol gives Isotretinoin EP Impurity I distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Isotretinoin EP Impurity I (CAS 75281-25-3) is a certified pharmaceutical impurity reference standard with the molecular formula C20H28O3 and a molecular weight of 316.43 g/mol.

The molecular framework of Isotretinoin EP Impurity I (C20H28O3) 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Isotretinoin EP Impurity I 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 FormulaC20H28O3
Molecular Weight316.43 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>90%
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.)1978

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