Dabigatran Impurity 109 CAS CATO-C4X-1089109
| CAS No. | CATO-C4X-1089109 |
| Molecular Formula | C24H29N5O4 |
| Molecular Weight | 451.52 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Dabigatran Impurity 109 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.
As a process- or degradation-related impurity, Dabigatran Impurity 109 (CAS CATO-C4X-1089109, C24H29N5O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Dabigatran Impurity 109 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 451.52 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C24H29N5O4 |
| Molecular Weight | 451.52 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 5 |
Related Dabigatran Standards
- Dabigatran impurity 134 (CAS 1912458-32-2)
- Dabigatran Impurity 153 (CAS CATO-C4X-1089153)
- Dabigatran Impurity 43 (CAS 212322-77-5)
- 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
- Valsartan N-Oxide (CAS CATO-C4X-105779)
- Valsartan Impurity 4 (Mixture of Diastereomers) (CAS 188259-69-0)
- Eltrombopag-d9 (CAS CATO-C4X-119818)
- Valsartan Impurity 149 (CAS CATO-C4X-1057149)
- Edoxaban Impurity N2 Dihydrochloride (CAS 1965310-23-9)
- Upadacitinib Impurity 177 (CAS CATO-C4X-2405177)
- Eperisone Impurity 42 (CAS 40475-69-2)
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- (6-(Difluoromethyl)-2,3-dimethoxypyridin-4-yl)methanamine (CAS 1805161-10-7)
- 5-Amino-4-cyano-3-methyl-N-phenylthiophene-2-carboxamide (CAS 173442-97-2)
- 2-(5-Bromo-2-iodophenyl)acetic acid (CAS 702641-01-8)
- Dodecanamide, N-[(1S)-1-(aminomethyl)-2-(ethylamino)-2-oxoethyl]-, hydrochloride (1:1) (CAS 2007921-23-3)
- tert-Butyl isoindolin-5-ylcarbamate (CAS 1093230-98-8)
- Des-Lys20(Side Chain)-Semaglutide (CAS CATO-C4X-2226280)
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