|
Items |
Specification |
|
Appearance: |
White crystalline powder |
|
Solubility: |
Practically insoluble in water, soluble in 96% ethanol, chloroform and glacial acetic acid, slightly soluble in ether. |
|
Melting point: |
163 to 167 celsius degree |
|
Specific rotation: |
+7.0 to +11.0 |
|
Loss on drying: |
Not more than 0.5% |
|
Heavy metals (Cu, Zn, Al, Hg): |
Not more than 20ppm |
|
Residual Solvents
Acetone:
Methanol:
Ethylacetate: |
Not more than 5000ppm
Not more than 3000ppm
Not more than 3000ppm |
|
Relative substances (by TLC)
1) Methyltestosterone:
2) Any other non-specified each: |
Not more than 0.5%
Not more than 0.5% |
|
Residue on ignition: |
Not more than 0.2% |
|
Assay (on dry basis): |
98-103% |
|
Particle size: |
100% pass through 200mesh sieve |
