Levonorgestrel EP Impurity H CAS 55555-97-0
| CAS No. | 55555-97-0 |
| Molecular Formula | C21H28O3 |
| Molecular Weight | 328.45 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Levonorgestrel EP Impurity H (CAS 55555-97-0, C21H28O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C21H28O3, Levonorgestrel EP Impurity H contains a steroid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 328.45 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
CATO manufactures Levonorgestrel EP Impurity H under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
Physical & Chemical Properties
| Molecular Formula | C21H28O3 |
| Molecular Weight | 328.45 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >90% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| 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.) | 1972 |
Related Levonorgestrel Standards
- Levonorgestrel Impurity 40 (10R) (CAS CATO-C4X-167740)
- Levonorgestrel Impurity 41 (CAS CATO-C4X-167741)
- Levonorgestrel EP Impurity G (CAS 87585-03-3)
- Levonorgestrel EP Impurity I (CAS 21508-50-9)
- Levonorgestrel EP Impurity I (CAS 20402-62-4)
- Levonorgestrel EP Impurity S (CAS 176254-10-7)
- Levonorgestrel EP Impurity T (CAS 14507-51-8)
- Levonorgestrel EP Impurity T (CAS 799-43-9)
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Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com