Dabigatran Impurity 92 CAS 211915-06-9
| CAS No. | 211915-06-9 |
| Molecular Formula | C34H41N7O5 |
| Molecular Weight | 627.73 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 627.73 g/mol gives Dabigatran Impurity 92 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Dabigatran Impurity 92 (CAS 211915-06-9) is a certified pharmaceutical impurity reference standard with the molecular formula C34H41N7O5 and a molecular weight of 627.73 g/mol.
Dabigatran Impurity 92 (C34H41N7O5) contains a nitrogen-containing heterocyclic scaffold, 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
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.
Physical & Chemical Properties
| Molecular Formula | C34H41N7O5 |
| Molecular Weight | 627.73 g/mol |
| Purity | >95% |
| 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 | 7 |
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