|
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
