Dydrogesterone EP Impurity A CAS 23035-53-2
| CAS No. | 23035-53-2 |
| Molecular Formula | C21H26O2 |
| Molecular Weight | 310.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Dydrogesterone EP Impurity A (C21H26O2) 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 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, Dydrogesterone EP Impurity A (CAS 23035-53-2, C21H26O2) 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.
As a certified reference material (CRM), Dydrogesterone EP Impurity A 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 Formula | C21H26O2 |
| Molecular Weight | 310.43 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
Related Dydrogesterone Standards
- Dydrogesterone Impurity 12; (CAS 17398-60-6)
- Dydrogesterone (CAS 152-62-5)
- Dydrogesterone EP Impurity C (CAS 246038-13-1)
- Dydrogesterone EP Impurity B (CAS CATO-C4X-218313)
- Dydrogesterone Impurity 23 (CAS CATO-C4X-218323)
- Dydrogesterone Impurity 8 (CAS CATO-C4X-21838)
- Dydrogesterone Impurity N3 (CAS 25093-47-4)
- Dydrogesterone Impurity 1 (CAS 1819-14-3)
Recommended Standards
- Levonorgestrel EP Impurity M (CAS 51087-61-7)
- Pregnenolone Impurity 8 (CAS 15346-23-3)
- Levonorgestrel EP Impurity A (CAS 1260525-53-8)
- Altrenogest Impurity 1 (CAS CATO-C4X-24831)
- Febuxostat Impurity 97 (CAS CATO-C4X-116297)
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