Tibolone EP Impurity B CAS CATO-C4X-240313
| CAS No. | CATO-C4X-240313 |
| Molecular Formula | C21H28O4 |
| Molecular Weight | 344.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Owing to a flavonoid core, a hydroxyl group, an ether linkage, Tibolone EP Impurity B is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 344.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
As a process- or degradation-related impurity, Tibolone EP Impurity B (CAS CATO-C4X-240313, C21H28O4) 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), Tibolone EP Impurity B 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 | C21H28O4 |
| Molecular Weight | 344.44 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 Impurity 14 (CAS 88247-84-1)
- Tibolone Impurity 10 (CAS 677299-58-0)
- Tibolone EP Impurity E (CAS 105186-33-2)
- Tibolone EP Impurity A (CAS CATO-C4X-240312)
- Tibolone EP Impurity A(10-β-Hydroxy 4-Tibolone) (CAS 105186-35-4)
- Tibolone D5 (CAS CATO-C4X-24034)
- Delta-4-Tibolone-D5 (CAS CATO-C4X-24037)
- Tibolone impurity 1 (CAS 100239-44-9)
Recommended Standards
- Ruxolitinib impurity 50 (CAS CATO-C4X-205850)
- 10-β-Peroxy 4-Tibolone (CAS 105186-34-3)
- Fluvoxamine Impurity 54 (CAS CATO-C4X-195154)
- S-(-)-Sulpiride-d3 (CAS 124020-27-5)
- Budesonide Impurity 76 (CAS CATO-C4X-138976)
- Cefadroxil Impurity 32 (CAS CATO-C4X-122432)
- Tryptophan EP Impurity L (CAS 287170-99-4)
- 3-(4-phenoxyphenyl)-2-sulfanyl-3,4-dihydroquinazolin-4-one (CAS 438029-86-8)
- Esomeprazole EP Impurity D (CAS 88546-55-8)
- 1-(7-(4,4,5,5-Tetramethyl-1,3,2-dioxaborolan-2-yl)-3,4-dihydroisoquinolin-2(1H)-yl)ethanone (CAS 937591-29-2)
- 6,6-dimethylpiperidine-2,4-dione (CAS 5239-39-4)
- Ethyl 5-(2-(2-oxo-2-(propylamino)acetyl)-1H-pyrrol-1-yl)-1-phenyl-1H-pyrazole-4-carboxylate (CAS 477709-25-4)
- 3-(Bromomethyl)-2-methylpentane (CAS 32444-35-2)
- Tau Peptide (244-274) (Repeat 1 Domain) trifluoroacetate salt (CAS 330456-24-1)
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