Dexamethasone Impurity 16 CAS 55541-30-5
| CAS No. | 55541-30-5 |
| Molecular Formula | C28H37FO7 |
| Molecular Weight | 504.59 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, Dexamethasone Impurity 16 (CAS 55541-30-5, C28H37FO7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Dexamethasone Impurity 16 (C28H37FO7) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a certified reference material (CRM), Dexamethasone Impurity 16 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 | C28H37FO7 |
| Molecular Weight | 504.59 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1972 |
| Halogen Content | F-containing |
Related Dexamethasone Standards
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- Dexamethasone Impurity 127 (CAS CATO-C4X-1165127)
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Recommended Standards
- Ticagrelor Impurity 54 (CAS CATO-C4X-109354)
- Lemborexant impurity 14 (CAS CATO-C4X-304214)
- Ticagrelor Impurity 14 (CAS 1643378-47-5)
- Betamethasone-17,21-Dipropionate (CAS 5593-20-4)
- Phloroglucinol Impurity 65 (CAS CATO-C4X-221765)
- Ticagrelor Impurity N40 (CAS 1006376-60-8)
- Vortioxetine Impurity 60 (CAS 1049755-55-6)
- Methyl 2-Amino-6-nitrobenzoate (CAS 57113-89-0)
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- 5-Hydroxy-2,6-dimethylpyrimidin-4(1H)-one (CAS 412003-94-2)
- 3-Bromo-2-(difluoromethoxy)thiophenol (CAS 1805528-05-5)
- 6-bromo-1-cyclopentyl-1H-indazole-4-carboxylic acid (CAS 1346703-24-9)
- 4-Hydroxy-3-propionyl-2H-chromen-2-one (CAS 4139-73-5)
- Peptide 436 (CAS CATO-CPTD788436)
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