Tretinoin EP Impurity B (9,13-di-cis-Retinoic Acid) CAS 5352-74-9

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.5352-74-9
Molecular FormulaC20H28O2
Molecular Weight300.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tretinoin EP Impurity B (9,13-di-cis-Retinoic Acid) CAS 5352-74-9 chemical structure

Description

As a process- or degradation-related impurity, Tretinoin EP Impurity B (9,13-di-cis-Retinoic Acid) (CAS 5352-74-9, C20H28O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, a hydroxyl group, an ether linkage, Tretinoin EP Impurity B (9,13-di-cis-Retinoic Acid) is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 300.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC20H28O2
Molecular Weight300.44 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>90%
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.)1958

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