TEST ITEMS | SPECIFICATION | RESULTS |
Description | : White or Almost White Crystalline Powder | |
Identification | : IR,UV | Positive |
Solubility | : Practically insoluble in water, soluble in | Conforms |
96% ethanol, in chloroform & glacial acetic | ||
acid, slightly soluble in ether. | ||
Assay(On dry basis) | : 97.0~103.0% | 99.70% |
Loss On Drying | : 0.5%max | 0.22% |
Residue On Ignition | : 0.2%max | 0.03% |
Specific Rotation | : +7° ~ +11°(1% w/v solution in 96% ethanol solution) | +9.3° |
Melting Point | : 163~167°C | 164.5~165.5°C |
Related Substances | : Methyltestosterone: 0.5%max | <0.5% |
Any other non-specified: 0.5%max | <0.5% | |
Residual Solvents | : Ethyl Acetate:5000PPm max | 210PPm |