Item | Specification | Result |
Appearance | An odorless, almost white or buff colored powder | pass |
Solubility | 1,Very slightly soluble in water | pass |
2,slightly soluble in alcohol | pass |
3,practically insoluble in most other organic solvents | pass |
4,disolves in diluted aqueous sodium hydroxide solutions | Pass |
Identificaton | a) Heat about 50 mg with a few drops of sulfuric acid in a porcelain crucible: violet vapors of iodine are evolved. | pass |
b)The retention time of the major peak is confirm to the RS | pass |
Loss on Drying | Not more than 4.0% | 0.46% |
[a]20/D C=1 in 1M HCl/EtOH 1:4 | +18 ~ +22o | +20.9o |
Assay(HPLC) | Not less than 95.0% | 99.18% |
Levothyroxine sodium | Not more than 5.0% |
China
