Fluocinolone Acetonide EP Impurity M CAS 356-12-7
| CAS No. | 356-12-7 |
| Molecular Formula | C26H32F2O7 |
| Molecular Weight | 494.52 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 Fluocinolone Acetonide EP Impurity M (CAS 356-12-7), a pharmacopoeial impurity reference standard (molecular formula C26H32F2O7, MW 494.52 g/mol) used for the identification and quantification of trace impurities in APIs.
Fluocinolone Acetonide EP Impurity M (C26H32F2O7) 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.
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 | C26H32F2O7 |
| Molecular Weight | 494.52 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| 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.) | 1957 |
| Halogen Content | F-containing |
Related Fluocinolone Standards
- Fluocinolone Acetonide Impurity 32 (CAS 3914-23-6)
- Fluocinolone Acetonide Impurity 24 (CAS CATO-C4X-238124)
- Fluocinolone Acetonide Impurity 23 (CAS CATO-C4X-238123)
- Fluocinolone Acetonide Impurity 27 (CAS 3932-49-8)
- Fluocinolone Acetonide Impurity 36 (CAS CATO-C4X-238136)
- Fluocinolone Acetonide Impurity 4 (CAS 62013-83-6)
- Fluocinolone Acetonide Impurity 37 (CAS CATO-C4X-238137)
- Fluocinolone Acetonide Impurity 35 (CAS CATO-C4X-238135)
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