Tadalafil EP Impurity H CAS 1978322-98-3
| CAS No. | 1978322-98-3 |
| Molecular Formula | C22H19N3O6 |
| Molecular Weight | 421.40 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Tadalafil EP Impurity H (CAS 1978322-98-3, C22H19N3O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Tadalafil EP Impurity H (C22H19N3O6) is characterized by a flavonoid core, 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.
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 | C22H19N3O6 |
| Molecular Weight | 421.40 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) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1996 |
| Nitrogen Atoms | 3 |
Related Tadalafil Standards
- Tadalafil Impurity 167 (CAS CATO-C4X-1087167)
- Tadalafil EP Impurity D (CAS CATO-C4X-10874)
- Tadalafil EP Impurity E (CAS 2520114-41-2)
- Tadalafil EP Impurity F (CAS 2747958-44-5)
- Tadalafil Impurity 32 (CAS CATO-C4X-108732)
- Tadalafil Impurity 62 (CAS CATO-C4X-108762)
- Tadalafil Impurity 82 (CAS CATO-C4X-108782)
- Tadalafil Impurity 162 (CAS CATO-C4X-1087162)
Recommended Standards
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- Rivaroxaban EP Impurity G (CAS 446292-08-6)
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