Tadalafil Impurity 101 CAS 20850-43-5
| CAS No. | 20850-43-5 |
| Molecular Formula | C8H7ClO2 |
| Molecular Weight | 170.59 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Tadalafil Impurity 101 (C8H7ClO2) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).
As a process- or degradation-related impurity, Tadalafil Impurity 101 (CAS 20850-43-5, C8H7ClO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 101 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.
Physical & Chemical Properties
| Molecular Formula | C8H7ClO2 |
| Molecular Weight | 170.59 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >90% |
| Storage | Store at 2-8°C, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1962 |
| Halogen Content | Cl-containing |
Related Tadalafil Standards
- Tadalafil Impurity 106 (CAS 23126-68-3)
- Tadalafil Impurity 53 (CAS 23170-77-6)
- Tadalafil Impurity 136 (CAS 52302-45-1)
- Tadalafil Impurity 137 (CAS 859964-45-7)
- Tadalafil Impurity 108 (CAS 771-39-1)
- Tadalafil Impurity 10 (CAS 100077-49-4)
- Tadalafil Impurity 79 (CAS 38082-70-1)
- Tadalafil Impurity 135 (CAS CATO-C4X-1087135)
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- Lamivudine Impurity B (CAS 141434-39-1)
- Febuxostat Impurity 14 (CAS 1350352-70-3)
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