Complaint
| Items | Standards | Results |
| Appearance | White or off-white crystalline powder | Complies |
| Identification | By IR | Complies |
| By TLC | Complies | |
| Solubility | Practically insoluble in water, soluble in acetone and ethanol(96%) | Complies |
| Appearance of Solution | Dissolve 0.2g in ethanol(96%) and dilute to 10mL with the same solvent,the solution is clear and colorless | Complies |
| Melting Point | 161.0ºC~165.0ºC | 162.4ºC~164.2ºC |
| Specific Rotation | -9.5°~-11.0° | -10.1° |
| Loss on Drying | ≤ 1.00% | 0.20% |
| Residual Solvents | Acetone: ≤3000ppm | 280ppm |
| Tetrahydrofuran: ≤720ppm | ND | |
| Ethanol ≤3000ppm | 1600ppm | |
| Related Substances | Impurity A: 19-nor-5a,17a-pregn-3-en-20-yn-17-ol: ≤0.30% | 0.07% |
| Impurity B: 19-norpregn-4-en-20-yn-17-ol: ≤0.10% | ND | |
| Impurity C: 19-nor-17a-pregna-4,20-dien-17-ol: ≤0.20% | ND | |
| Degradant: ≤0.10% | ND | |
| Unspecified impurities: ≤0.10% | ND | |
| Total Impurities: ≤1.00% | 0.07% | |
| Assay (on the anhydrous basis) | 98.0%~102.0% | 99.60% |
| Particle Size | D90: ≤15µm | Complies |
| Reference Standard | BP2014 Standard | |
| Conclusion | The product complied to BP2014 standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
