Fludarabine Impurity 18 CAS 15811-32-2
| CAS No. | 15811-32-2 |
| Molecular Formula | C16H18FN5O7 |
| Molecular Weight | 411.34 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Fludarabine Impurity 18 (CAS 15811-32-2) is a certified pharmaceutical impurity reference standard with the molecular formula C16H18FN5O7 and a molecular weight of 411.34 g/mol.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Fludarabine Impurity 18 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 411.34 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
Physical & Chemical Properties
| Molecular Formula | C16H18FN5O7 |
| Molecular Weight | 411.34 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; 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.) | 1961 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |
Related Fludarabine Standards
- Fludarabine Impurity 19 (CAS CATO-C4X-184619)
- Fludarabine Impurity 17 (CAS CATO-C4X-184617)
- Fludarabine Phosphate EP Impurity F (CAS 159002-28-5)
- Fludarabine Phosphate EP Impurity G (CAS 548774-56-7)
- Fludarabine Phosphate EP Impurity C (CAS 548774-53-4)
- Fludarabine Phosphate EP Impurity J (CAS CATO-C4X-184610)
- Fludarabine Phosphate Impurity 11 (CAS CATO-C4X-184611)
- Fludarabine Phosphate (CAS 75607-67-9)
Recommended Standards
- 3633-28-1 CTK1C5323 [3,4-diacetyloxy-5-(2-amino-6-fluoro-purin-9-yl)oxolan-2-yl]methyl acetate (CAS 3633-28-1)
- 5-(5-Bromo-2-oxo-1-propylindolin-3-ylidene)-3-ethyl-2-thioxothiazolidin-4-one (CAS 617696-85-2)
- 1-(4-Fluoro-5-methyl-2-nitrophenyl)-4-[4-(trifluoromethyl)benzoyl]piperazine (CAS 1262222-55-8)
- (2R,3R,4R,5R)-2-(Acetoxymethyl)-5-(6-amino-8-fluoro-9H-purin-9-yl)tetrahydrofuran-3,4-diyl diacetate (CAS 23205-66-5)
- Revefenacin Impurity 17 (CAS 96053-48-4)
- Atracurium Impurity 42 (CAS CATO-C4X-185042)
- Avibactam Impurity 119 (CAS CATO-C4X-1348119)
- 2-(Cyanomethyl)-3-(difluoromethyl)-6-fluoroisonicotinonitrile (CAS 1805352-37-7)
- 3-(4-Chlorobenzenesulfonamido)-3-(4-fluorophenyl)propanoic acid (CAS 440646-68-4)
- 4-[3-(dimethylamino)propoxy]benzylamine (CAS 91637-76-2)
- 4-Hydroxy-3-quinolinemethanol (CAS 82121-18-4)
- 3-(hydroxymethyl)azetidin-3-ol (CAS 934672-00-1)
- Ethyl 1-ethyl-5-oxo-4,5-dihydro-1h-pyrazole-3-carboxylate (CAS 1315368-17-2)
- Semaglutide impurity 78 (CAS CATO-C4X-222678)
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