Applications:
Tadalafil is a PDE5 inhibitor marketed in pill form for treating erectile dysfunction (ED) under the name Tadalafil, and under the name Adcirca for the treatment of pulmonary arterial
hypertension.
Tadalafil's pharmacologic distinction is its longer half-life (17.50 hours) resulting in longer duration of action, and so partly responsible for "The Weekend Pill" sobriquet. Furthermore, the
longer half-life is the basis for current investigation of tadalafil's daily therapeutic use in relieving pulmonary arterial hypertension.
Specifications:
Test Items | Specification | Test Results |
Appearance | White powder | Conforms |
Test method | High pressure liquid chromatography(HPLC) | Conforms |
Melting Point | 300℃~303℃ | 301.5℃-302.6℃ |
Loss on drying | ≤0.5% | 0.24% |
Heavy metals(Pb) | ≤20ppm | 7.5ppm |
Residue on ignition | ≤0.1% | 0.08% |
Relative substance | ≤1.0% | 0.145% |
Assay (on dried basis) | ≥98.5% | 99.33% |
Conclusion | The product conform to USP 32. |