Dapagliflozin impurity 16 CAS CATO-C4X-1138216
| CAS No. | CATO-C4X-1138216 |
| Molecular Formula | C22H25ClO5 |
| Molecular Weight | 404.88 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Dapagliflozin impurity 16 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.
As a process- or degradation-related impurity, Dapagliflozin impurity 16 (CAS CATO-C4X-1138216, C22H25ClO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C22H25ClO5, Dapagliflozin impurity 16 contains a flavonoid core, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 404.88 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C22H25ClO5 |
| Molecular Weight | 404.88 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
Related Dapagliflozin Standards
- Dapagliflozin Impurity 108 (CAS CATO-C4X-1138108)
- Dapagliflozin Impurity 184 (CAS CATO-C4X-1138184)
- Dapagliflozin Impurity 154 (CAS CATO-C4X-1138154)
- Dapagliflozin Impurity 34 (CAS CATO-C4X-113834)
- Dapagliflozin Furanose Isomer (CAS 1469910-70-0)
- Dapagliflozin Impurity N9 (CAS 2452300-81-9)
- Dapagliflozin (CAS 461432-26-8)
- Dapagliflozin Impurity 1 (CAS 1373321-04-0)
Recommended Standards
- 3,4,6-Tribromodibenzo[b,d]furan (CAS 617707-56-9)
- 1-(2-Chlorophenyl)-N-(3-phenylpropyl)-5-(1H-pyrrol-1-yl)-1H-pyrazole-4-carboxamide (CAS 1206997-67-2)
- 2,3,8-Tribromodibenzofuran (CAS 84761-82-0)
- Tert-butyl (1-(6-chloro-2-phenoxypyrimidin-4-yl)piperidin-3-yl)carbamate (CAS 1334149-00-6)
- Regorafenib Impurity 79 (CAS CATO-C4X-104779)
- Axitinib Impurity 14 (CAS CATO-C4X-107114)
- Glimepiride Impurity 10 (CAS 600177-94-4)
- 4-(2,5-Difluorobenzoyl)-2-methylpyridine (CAS 1187167-40-3)
- n-Ethyl-2,4-dimethylbenzenesulfonamide (CAS 257953-14-3)
- (2S,3R,4R,5S,6R)-3-amino-6-(hydroxymethyl)tetrahydro-2H-pyran-2,4,5-triol (CAS 6490-70-6)
- 2-((2,3-Dichlorobenzyl)(ethyl)amino)ethanol (CAS 1353983-37-5)
- 6-Oxo-4-(trifluoromethyl)-1,6-dihydropyridine-2-carboxylic acid (CAS 1393558-71-8)
- 2-Phenyl-N-(2-((5-phenyl-1H-imidazol-2-yl)thio)ethyl)acetamide (CAS 897456-02-9)
- Insulin Degludec Impurity 6 (CAS CATO-C4X-21576)
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