Dabigatran Impurity 78 CAS 1369943-91-8
| CAS No. | 1369943-91-8 |
| Molecular Formula | C8H8N2O4 |
| Molecular Weight | 196.16 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO manufactures Dabigatran Impurity 78 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
CATO supplies Dabigatran Impurity 78 (CAS 1369943-91-8), a pharmacopoeial impurity reference standard (molecular formula C8H8N2O4, MW 196.16 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Dabigatran Impurity 78 (C8H8N2O4) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
Physical & Chemical Properties
| Molecular Formula | C8H8N2O4 |
| Molecular Weight | 196.16 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Nitrogen Atoms | 2 |
Related Dabigatran Standards
- Dabigatran Impurity 69 (CAS 41263-74-5)
- Dabigatran Impurity 68 (CAS 103041-38-9)
- Dabigatran Impurity 75 (CAS 355809-32-4)
- Dabigatran Impurity 93 (CAS 7452-59-7)
- Dabigatran Etexilate Impurity 84 (CAS 175867-55-7)
- Dabigatran Impurity 83 (CAS 218168-58-2)
- Dabigatran Impurity 103 (CAS CATO-C4X-1089103)
- Dabigatran Etexilate Impurity 2 (CAS 333350-60-0)
Recommended Standards
- Azilsartan impurity 145 (CAS CATO-C4X-1096145)
- 3,4-(Methylenedioxy)mandelic acid (CAS 27738-46-1)
- 2,4-Dinitro-m-xylene (CAS 603-02-1)
- 3,7-Dimethyluric acid (CAS 13087-49-5)
- Famotidine EP Impurity I (CAS 1020719-36-1)
- Roxadustat Impurity 162 (CAS CATO-C4X-2213162)
- Mirabegron Impurity 22 (CAS 861337-74-8)
- 3,3-Dimethyl 1-Indanone (CAS 26465-81-6)
- Olaparib impurity 139 (CAS 42086-73-7)
- 2-Bromo-4-fluoro-6-methylbenzenethiol (CAS 1208076-78-1)
- 1,3-Dimethyl 5,5-dicyano-2-hydroxy-6-[4-(methylsulfanyl)phenyl]-4-(pyridin-4-yl)cyclohex-1-ene-1,3-dicarboxylate (CAS 1212117-99-1)
- 33950-46-8 2,2-dimethyl-1-phenylpropane-1,3-diol DTXSID50290873 (CAS 33950-46-8)
- N-Benzyl-1-(1-methyl-1H-pyrazol-4-yl)methanamine (CAS 1006464-77-2)
- Thymopoietin II Peptide Fragment (CAS 56795-64-3)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com