Betamethasone Impurity 57 CAS 1257544-85-6
| CAS No. | 1257544-85-6 |
| Molecular Formula | C22H27FO5 |
| Molecular Weight | 390.45 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Betamethasone Impurity 57.
As a process- or degradation-related impurity, Betamethasone Impurity 57 (CAS 1257544-85-6, C22H27FO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Betamethasone Impurity 57 (C22H27FO5) is characterized by a flavonoid core, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, 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).
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), Betamethasone Impurity 57 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 | C22H27FO5 |
| Molecular Weight | 390.45 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1990 |
| Halogen Content | F-containing |
Related Betamethasone Standards
- Betamethasone impurity 100 (CAS CATO-C4X-1437100)
- Betamethasone impurity 49 (CAS CATO-C4X-143749)
- Betamethasone impurity 61 (CAS 1257544-84-5)
- Betamethasone Impurity 124 (CAS 947382-36-7)
- Betamethasone Impurity 22 (CAS 2990-65-0)
- Betamethasone EP Impurity H (CAS 185613-71-2)
- Betamethasone Impurity 117 (CAS CATO-C4X-1437117)
- Betamethasone Impurity 145 (CAS CATO-C4X-1437145)
Recommended Standards
- Tafluprost Impurity 2 (CAS CATO-C4X-21632)
- 21-Dehydro Dexamethasone (CAS 2964-79-6/4619-61-8)
- Isodecyl Diphenyl Phosphate (CAS 29761-21-5)
- Phenyl(3-(tosylmethyl)benzofuran-2-yl)methanone (CAS 338423-87-3)
- Sitafloxacin Impurity 29 (CAS CATO-C4X-115529)
- Piribedil Impurity N2 (CAS 263-29-6)
- Dronedarone Impurity 14 (CAS 1278585-70-8)
- (4-Aminopiperidin-1-yl)(thiophen-2-yl)methanone (CAS 886497-83-2)
- 1-(Azetidin-3-yl)-4-fluoropiperidine (CAS 194427-25-3)
- Methyl 5-bromo-3-oxo-3,4-dihydro-2H-benzo[b][1,4]oxazine-7-carboxylate (CAS 214848-39-2)
- 1,4,8-Tribromodibenzo[b,d]furan (CAS 617707-45-6)
- 6-(Naphthalen-2-ylmethyl)-2-thioxo-2,3-dihydropyrimidin-4(1H)-one (CAS 108618-38-8)
- Cholest-3-ene (CAS 16732-84-6)
- Tirzepatide Impurity 35 (CAS CATO-C4X-324035)
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