| CAS No. | 23170-77-6 |
| Molecular Formula | C3H4Cl3NO |
| Molecular Weight | 176.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Tadalafil Impurity 53 is closely related to an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Tadalafil Impurity 53 (CAS 23170-77-6, C3H4Cl3NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Tadalafil Impurity 53 (C3H4Cl3NO) contains an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 1.0, corresponding to approximately 1 ring(s) or double-bond equivalent(s). With a molecular weight of 176.43 g/mol, it falls into the medium-molecular-weight range. 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.
As a certified reference material (CRM), Tadalafil Impurity 53 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.
| Molecular Formula | C3H4Cl3NO |
| Molecular Weight | 176.43 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 1963 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |