Isotretinoin EP Impurity G (5,6-Epoxy-13-cis Retinoic Acid) (and enantiomer) CAS 81444-57-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.81444-57-7
Molecular FormulaC20H28O3
Molecular Weight316.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Isotretinoin EP Impurity G (5,6-Epoxy-13-cis Retinoic Acid) (and enantiomer) CAS 81444-57-7 chemical structure

Description

The molecular framework of Isotretinoin EP Impurity G (5,6-Epoxy-13-cis Retinoic Acid) (and enantiomer) (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).

As a process- or degradation-related impurity, Isotretinoin EP Impurity G (5,6-Epoxy-13-cis Retinoic Acid) (and enantiomer) (CAS 81444-57-7, C20H28O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 G (5,6-Epoxy-13-cis Retinoic Acid) (and enantiomer) 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>95%
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.)1980

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