Dabigatran Impurity 30 CAS 948551-71-1
| CAS No. | 948551-71-1 |
| Molecular Formula | C27H28N6O4 |
| Molecular Weight | 500.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Dabigatran Impurity 30 (CAS 948551-71-1, C27H28N6O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Dabigatran Impurity 30 (C27H28N6O4) 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).
As a certified reference material (CRM), Dabigatran Impurity 30 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 | C27H28N6O4 |
| Molecular Weight | 500.55 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) | 17.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 6 |
Related Dabigatran Standards
- Dabigatran Impurity 8 (CAS 1422435-41-3)
- Dabigatran Impurity 91 (CAS CATO-C4X-108991)
- Dabigatran Impurity 131 (CAS 429658-95-7)
- Dabigatran Impurity 120 (CAS CATO-C4X-1089120)
- Dabigatran Isopropyl Ester Impurity (CAS 1610758-17-2)
- Dabigatran Impurity 12 (CAS CATO-C4X-108912)
- Dabigatran Methyl Ester Impurity (CAS 771459-37-1)
- Dabigatran Impurity 26 (CAS 211915-84-3)
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