Dabigatran Impurity 104 CAS CATO-C4X-1089104
| CAS No. | CATO-C4X-1089104 |
| Molecular Formula | C22H24N4O5 |
| Molecular Weight | 424.45 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 Dabigatran Impurity 104.
Dabigatran Impurity 104 (CAS CATO-C4X-1089104) is a certified pharmaceutical impurity reference standard with the molecular formula C22H24N4O5 and a molecular weight of 424.45 g/mol.
Dabigatran Impurity 104 (C22H24N4O5) contains a flavonoid 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 104 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 | C22H24N4O5 |
| Molecular Weight | 424.45 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 4 |
Related Dabigatran Standards
- Dabigatran Impurity 115 (CAS CATO-C4X-1089115)
- Dabigatran Impurity 80 (CAS 1307233-94-8)
- Dabigatran Impurity 153 (CAS CATO-C4X-1089153)
- Dabigatran Impurity 109 (CAS CATO-C4X-1089109)
- Dabigatran impurity 134 (CAS 1912458-32-2)
- Dabigatran Impurity 43 (CAS 212322-77-5)
- Dabigatran Impurity 133 (CAS CATO-C4X-1089133)
- Dabigatran Impurity 127 (CAS 1422435-37-7)
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