Difluprednate Impurity N1 CAS 23640-96-2
| CAS No. | 23640-96-2 |
| Molecular Formula | C25H32F2O6 |
| Molecular Weight | 466.51 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Difluprednate Impurity N1 (CAS 23640-96-2) is a certified pharmaceutical impurity reference standard with the molecular formula C25H32F2O6 and a molecular weight of 466.51 g/mol.
The molecular framework of Difluprednate Impurity N1 (C25H32F2O6) 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), Difluprednate Impurity N1 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 | C25H32F2O6 |
| Molecular Weight | 466.51 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
| Halogen Content | F-containing |
Related Difluprednate Standards
- Difluprednate Impurity 1 (CAS CATO-C4X-21781)
- Difluprednate Impurity 4 (CAS 1296262-60-6)
- Difluprednate (CAS 23674-86-4)
- Difluprednate Impurity N2 (CAS 2326-26-3)
- Difluprednate Impurity 3 (CAS 1234557-20-0)
- Difluprednate Impurity 2 (CAS 2285-44-1)
- Difluprednate Impurity 5 (CAS 1270039-29-6)
- Difluprednate Impurity 6 (CAS 167997-12-8)
Recommended Standards
- 2-((3-Cyano-4,6-diphenylpyridin-2-yl)thio)-N-(4-nitrophenyl)acetamide (CAS 332040-33-2)
- 3-Amino-N-(2-nitrophenyl)-4,6-diphenylthieno[2,3-b]pyridine-2-carboxamide (CAS 352435-70-2)
- 2-((3-Cyano-4,6-diphenylpyridin-2-yl)thio)-N-(2-nitrophenyl)acetamide (CAS 332053-13-1)
- 4-Nitrophenyl S-benzyl-N-((benzyloxy)carbonyl)-L-cysteinate (CAS 3401-37-4)
- Benzbromarone Impurity 20 (CAS 2514676-29-8)
- Glycopyrronium Bromide Impurity 7 (CAS 1404453-68-4)
- Bifonazole impurity 11 (CAS 73842-48-5)
- 4,5-Dichloro-6-methyl-2-(2-pyridyl)pyrimidine 4,5-Dichloro-6-methyl-2-pyridin-2-ylpyrimidine 4,5-Dichloro-6-methyl-2-(pyridin-2-yl)pyrimidine 4,5-Dichloro-6-methyl-2-(2-pyridinyl)pyrimidine 306935-55-7 (CAS 306935-55-7)
- Biotin Impurity 5 (CAS 57229-92-2)
- 3-Methyl-2-(5-(methylamino)-1,3,4-thiadiazol-2-yl)-7,8-dihydropyrrolo[1,2-a]thieno[2,3-d]pyrimidin-4(6H)-one (CAS 883276-11-7)
- 3-Octylpyridine (CAS 58069-37-7)
- Ethyl 2-(4-Nitrophenyl)thiazole-4-carboxylate (CAS 78979-64-3)
- 2′-(3-Dodecylphenyl)-1′,5′-dihydro-1′-methyl-2′H-[5,6]fullereno-C60-Ih-[1,9-c]pyrrole (CAS 403483-19-2)
- Semaglutide impurity 29 (CAS CATO-C4X-222629)
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