| CAS No. | 5352-74-9 |
| Molecular Formula | C20H28O2 |
| Molecular Weight | 300.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
| Molecular Formula | C20H28O2 |
| Molecular Weight | 300.44 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >90% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |