Dabigatran Impurity 131 Hydrochloride CAS 211914-50-0
| CAS No. | 211914-50-0 |
| Molecular Formula | C27H29N7O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Dabigatran Impurity 131 Hydrochloride (CAS 211914-50-0) is a certified pharmaceutical impurity reference standard with the molecular formula C27H29N7O3HCl and a molecular weight of 536.03 g/mol.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Dabigatran Impurity 131 Hydrochloride is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 536.03 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.
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 | C27H29N7O3 HCl |
| Molecular Weight | 536.03 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 16.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2017 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 7 |
Related Dabigatran Standards
- Dabigatran Impurity 136 (CAS 1015167-27-7)
- Dabigatran Acyl-β-D-Glucuronide (CAS 1015167-40-4)
- Dabigatran Acyl-B-D-Glucuronide-d3 as TFA Salt (CAS 1015167-40-4 (unlabeled))
- Dabigatran Acyl-β-D-Glucuronide-D3 TFA Salt (CAS 1015167-40-4 (unlabelled))
- Dabigatran Acyl-β-D-Glucuronide TFA Salt (CAS 1015167-40-4 （free base）)
- Dabigatran Impurity 68 (CAS 103041-38-9)
- Dabigatran Impurity 3 Hydrobromide (CAS 1046806-03-4)
- Dabigatran Impurity 85 (CAS 104961-64-0)
Recommended Standards
- Tadalafil Impurity 173 (CAS CATO-C4X-1087173)
- Macitentan Impurity 8 (CAS 38353-06-9)
- Finerenone Impurity 77 (CAS CATO-C4X-288077)
- 4,6-Dichloro-5-nitro-2-(pyridin-2-yl)pyrimidine (CAS 1188037-64-0)
- Methyl[1-(pyridin-2-yl)ethyl]amine (CAS 114366-07-3)
- 2-(2-(Ethyl(methyl)amino)pyridin-3-yl)pyrrolidine-1-carbaldehyde (CAS 1352495-65-8)
- N-(4-tert-butyl-phenyl)-6-chloro-pyrimidine-2,4-diamine (CAS 335444-26-3)
- (E)-6-(2-((2,4-difluorophenyl)amino)vinyl)pyrazolo[1,5-a]pyrido[3,4-e]pyrimidine-3-carbonitrile (CAS 338411-69-1)
- Voriconazole Impurity 66 (CAS CATO-C4X-136666)
- Palmitoyl Tripeptide-8 TFA salt (CAS 936544-53-5)
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