Dabigatran Impurity 43 CAS 212322-77-5
| CAS No. | 212322-77-5 |
| Molecular Formula | C25H22N6O3 |
| Molecular Weight | 454.48 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 43.
Dabigatran Impurity 43 (CAS 212322-77-5) is a certified pharmaceutical impurity reference standard with the molecular formula C25H22N6O3 and a molecular weight of 454.48 g/mol.
Dabigatran Impurity 43 (C25H22N6O3) 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 43 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 | C25H22N6O3 |
| Molecular Weight | 454.48 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 109 (CAS CATO-C4X-1089109)
- Dabigatran impurity 134 (CAS 1912458-32-2)
- Dabigatran Impurity 153 (CAS CATO-C4X-1089153)
- Dabigatran Impurity 44 (CAS 211916-39-1)
- 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)
Recommended Standards
- N-Nitroso Cinacalcet Impurity 8 (CAS CATO-C4X-105979)
- Candesartan Cilexetil EP Impurity I (CAS 139481-69-9)
- Copanlisib impurity B (CAS 2132943-81-6)
- (2R,3R,4S,5S,6R)-2-(acetoxymethyl)-6-(benzylthio)tetrahydro-2H-pyran-3,4,5-triyl triacetate (CAS 74590-46-8)
- Indobufen Impurity 21 (CAS CATO-C4X-179221)
- Metaraminol Impurity 80 (CAS CATO-C4X-225280)
- Teneligliptin impurity 58 (CAS CATO-C4X-176058)
- 1-(2-Phenylethyl)-1h-1,2,3-triazole-4-carboxylic acid (CAS 889940-03-8)
- 2,4-Dichloro-3-nitrobenzoic acid (CAS 39053-42-4)
- (6-Methoxypyrazin-2-yl)methanamine (CAS 1187221-99-3)
- Cis-3a,4,5,6,7,8,9,9a-octahydrocycloocta[d]isoxazole (CAS 61080-94-2)
- 2-(2-Oxopiperidin-1-yl)benzoic acid (CAS 78648-35-8)
- Methyl 5-methylthiomorpholine-3-carboxylate 1-oxide (CAS 1869084-48-9)
- Galanin-Like Peptide (rat) trifluoroacetate salt (CAS 245114-97-0)
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