Tadalafil Impurity 145 CAS 629652-47-7
| CAS No. | 629652-47-7 |
| Molecular Formula | C22H21ClN2O4 |
| Molecular Weight | 412.87 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Tadalafil Impurity 145 (CAS 629652-47-7, C22H21ClN2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Tadalafil Impurity 145 (C22H21ClN2O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 412.87 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C22H21ClN2O4 |
| Molecular Weight | 412.87 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1985 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Tadalafil Standards
- Tadalafil Impurity 31 (CAS 2058231-08-4)
- Tadalafil Impurity 139 (CAS CATO-C4X-1087139)
- Tadalafil Impurity 57 (CAS CATO-C4X-108757)
- Tadalafil impurity 126 (CAS CATO-C4X-1087126)
- Tadalafil Impurity 171 (CAS CATO-C4X-1087171)
- Tadalafil Impurity 162 (CAS CATO-C4X-1087162)
- Tadalafil Impurity 82 (CAS CATO-C4X-108782)
- Tadalafil Impurity 106 (CAS 1356345-67-9)
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- 6-Bromo-4-chlorobenzo[d]oxazol-2(3H)-one (CAS 1226072-99-6)
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