Dabigatran Impurity 100 CAS CATO-C4X-1089100
| CAS No. | CATO-C4X-1089100 |
| Molecular Formula | C18H22N4O4 |
| Molecular Weight | 358.39 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 358.39 g/mol gives Dabigatran Impurity 100 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Dabigatran Impurity 100 (CAS CATO-C4X-1089100) is a certified pharmaceutical impurity reference standard with the molecular formula C18H22N4O4 and a molecular weight of 358.39 g/mol.
Structurally, Dabigatran Impurity 100 (C18H22N4O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 358.39 g/mol, it falls into the moderately-high-molecular-weight range. 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.
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 | C18H22N4O4 |
| Molecular Weight | 358.39 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 4 |
Related Dabigatran Standards
- Dabigatran Impurity 107 (CAS CATO-C4X-1089107)
- Dabigatran Impurity 113 (CAS CATO-C4X-1089113)
- Dabigatran Impurity 15 (CAS 1702936-92-2)
- Dabigatran Impurity 71 (CAS 1422435-40-2)
- Dabigatran Impurity 22 (CAS 1408238-41-4)
- Dabigatran Impurity 28 (CAS 1456889-80-7)
- Dabigatran Impurity 27 (CAS 1642853-67-5)
- Dabigatran Impurity 116 (CAS CATO-C4X-1089116)
Recommended Standards
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- Avanafil Impurity 20 (CAS 2250242-42-1)
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- Carboprost Trometamol EP Impurity B (CAS 35864-81-4)
- Limaprost Impurity 9 (CAS CATO-C4X-21459)
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- Ethyl 4-methyl-3H-pyrrole-3-carboxylate (CAS 85960-28-7)
- 1-(3,4-Dimethylphenyl)-4-isocyanato-2-pyrrolidinone (CAS 1082350-64-8)
- 1-(4-Chloro-3-(methylsulfonyl)phenyl)propan-2-one (CAS 593960-75-9)
- 4-Chlorobutyraldehyde Diethyl Acetal (CAS 6139-83-9)
- Semaglutide impurity 76 (CAS CATO-C4X-222676)
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