Dienogest EP Impurity F CAS 67473-36-3
| CAS No. | 67473-36-3 |
| Molecular Formula | C20H27NO2 |
| Molecular Weight | 313.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Dienogest EP Impurity F is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 313.43 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).
As a process- or degradation-related impurity, Dienogest EP Impurity F (CAS 67473-36-3, C20H27NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 Formula | C20H27NO2 |
| Molecular Weight | 313.43 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1976 |
| Nitrogen Atoms | 1 |
Related Dienogest Standards
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