Difluprednate Impurity 2 CAS 2285-44-1
| CAS No. | 2285-44-1 |
| Molecular Formula | C21H24F2O4 |
| Molecular Weight | 378.41 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 Difluprednate Impurity 2.
CATO supplies Difluprednate Impurity 2 (CAS 2285-44-1), a pharmacopoeial impurity reference standard (molecular formula C21H24F2O4, MW 378.41 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Difluprednate Impurity 2 (C21H24F2O4) contains a flavonoid core, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 378.41 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
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 | C21H24F2O4 |
| Molecular Weight | 378.41 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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; 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.) | 1957 |
| Halogen Content | F-containing |
Related Difluprednate Standards
- Difluprednate Impurity 5 (CAS 1270039-29-6)
- Difluprednate Impurity 3 (CAS 1234557-20-0)
- Difluprednate Impurity 6 (CAS 167997-12-8)
- Difluprednate Impurity N2 (CAS 2326-26-3)
- Difluprednate Impurity N1 (CAS 23640-96-2)
- Difluprednate Impurity 1 (CAS CATO-C4X-21781)
- Difluprednate Impurity 4 (CAS 1296262-60-6)
- Difluprednate (CAS 23674-86-4)
Recommended Standards
- 4-((Triphenyl-lambda5-phosphanylidene)amino)benzonitrile (CAS 74395-06-5)
- 3,6,9,12,15,18,21-Heptaoxatetracos-1-yn-24-oic acid (CAS 1818294-28-8)
- Methyl 2-(5-benzyl-4,6-dioxo-3-phenyloctahydropyrrolo[3,4-c]pyrrol-1-yl)acetate (CAS 1008006-46-9)
- 4-Methyl-N-(2-((3-(pyridin-4-yl)-1,2,4-oxadiazol-5-yl)methyl)phenyl)-1,2,3-thiadiazole-5-carboxamide (CAS 1797267-69-6)
- Atorvastatin EP Impurity E (CAS 110862-48-1（Relative）)
- Salbutamol Impurity 126 (CAS CATO-C4X-1176126)
- Elagolix Impurity 89 (CAS CATO-C4X-206889)
- methyl 2-({[(tert-butoxy)carbonyl]amino}amino)-2-phenylacetate (CAS 182887-79-2)
- Tert-butyl 4'-methyl-[1,1'-biphenyl]-2-carboxylate (CAS 114772-36-0)
- 2-(Methylthio)-N-(2,3,4-trifluorophenyl)nicotinamide (CAS 785799-95-3)
- 4-Methyl-8-(1-(phenylsulfonyl)-1H-indol-2-yl)dihydro-4l4,8l4-[1,3,2]oxazaborolo[2,3-b][1,3,2]oxazaborole-2,6(3H,5H)-dione (CAS 1158984-95-2)
- 2-Phenyl-1h-pyrrolo[2,3-b]pyridin-5-amine (CAS 896116-37-3)
- Baricitinib Impurity 26 (CAS CATO-C4X-226026)
- Semaglutide impurity 56 (CAS CATO-C4X-222656)
Why CATO?
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