Dabigatran Impurity 44 CAS 211916-39-1
| CAS No. | 211916-39-1 |
| Molecular Formula | C26H24N6O3 |
| Molecular Weight | 468.51 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Dabigatran Impurity 44 (CAS 211916-39-1, C26H24N6O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Dabigatran Impurity 44 (C26H24N6O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
As a certified reference material (CRM), Dabigatran Impurity 44 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 | C26H24N6O3 |
| Molecular Weight | 468.51 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 18.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2017 |
| Nitrogen Atoms | 6 |
Related Dabigatran Standards
- Dabigatran Impurity 54 (CAS 1643377-48-3)
- Dabigatran (CAS 211914-51-1)
- Dabigatran Impurity 70 (CAS CATO-C4X-108970)
- Dabigatran-d3 (CAS 1246817-44-6)
- Dabigatran-13C-d3 (CAS CATO-C4X-108981)
- Dabigatran 13C6 (CAS 1210608-88-0)
- Dabigatran Impurity 137 (CAS CATO-C4X-1089137)
- Dabigatran Impurity 4 (CAS 1408238-36-7)
Recommended Standards
- DTP67-Br-CHO (CAS 1445739-57-0)
- Candesartan Cilexetil EP Impurity A (CAS 139481-58-6)
- Fmoc-β-Ala-Cit-OH (CAS CATO-CPTD788369)
- Candesartan N2-Ethyl Impurity (CAS 1246819-02-2)
- Vardenafil Impurity 56 (CAS CATO-C4X-101756)
- Glycyrrhizic Acid Impurity 34 (CAS CATO-C4X-253734)
- Etoricoxib impurity 53 (CAS 646459-43-0)
- 3-(2-Chloro-4-(trifluoromethyl)pyridin-3-yl)propan-1-amine (CAS 1393538-77-6)
- N-(azetidin-3-yl)acetamide (CAS 102065-88-3)
- 7-Fluoro-3,4-dihydro-4-[(5-isoquinolinyloxy)acetyl]-1,3,3-trimethyl-2(1H)-quinoxalinone (CAS 878292-27-4)
- 4-(1-Methyl-1H-imidazol-2-yl)-1,2,3,6-tetrahydropyridine (CAS 630120-23-9)
- Tert-butyl ((3S,4R)-4-hydroxypyrrolidin-3-yl)(methyl)carbamate (CAS 2227198-27-6)
- N-(2-fluoro-6-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl)pivalamide (CAS 2390149-51-4)
- Semaglutide Impurity 137 (x TFA Salt) (CAS CATO-C4X-2226137)
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