Tibolone EP Impurity A CAS CATO-C4X-240312
| CAS No. | CATO-C4X-240312 |
| 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.
CATO supplies Tibolone EP Impurity A (CAS CATO-C4X-240312), a pharmacopoeial impurity reference standard (molecular formula C21H28O3, MW 328.45 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C21H28O3, Tibolone EP Impurity A 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 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).
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 | C21H28O3 |
| Molecular Weight | 328.45 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| 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 |
Related Tibolone Standards
- Tibolone EP Impurity A(10-β-Hydroxy 4-Tibolone) (CAS 105186-35-4)
- Tibolone Impurity 14 (CAS 88247-84-1)
- Tibolone D5 (CAS CATO-C4X-24034)
- Delta-4-Tibolone-D5 (CAS CATO-C4X-24037)
- Tibolone impurity 1 (CAS 100239-44-9)
- Tibolone impurity 2 (CAS 100239-45-0)
- Tibolone EP Impurity B (CAS CATO-C4X-240313)
- Tibolone (CAS 5630-53-5)
Recommended Standards
- Estrone Impurity 11 (CAS CATO-C4X-210511)
- Levonorgestrel EP Impurity I (CAS 21508-50-9)
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- Levonorgestrel EP Impurity H (CAS 55555-97-0)
- Micafungin Impurity 25 (CAS CATO-C4X-169525)
- Lenvatinib Impurity N1 (CAS 28443-57-4)
- Metamizole EP Impurity C (CAS 519-98-2)
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- 4'-Ethynyl-[1,1'-biphenyl]-2-amine (CAS 723748-82-1)
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- 4-(2-Isocyanatoethyl)-1,2-dimethoxybenzene (CAS 35167-81-8)
- Insulin aspart (CAS 116094-23-6)
Why CATO?
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- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com