Analysis Items

Specification

 Results

Appearance

White to off-white powder

Solubility

Very soluble in water and in methanol; ractically in soluble or insoluble in ether and in chloroform.

Complies

Identification(IR)

Conforms to the spectrum of the Reference.

Complies

Identification(HPLC)

The retention times of two principal peaks of the sample solution correspond to those of the system suitability solution, as obtained in the test for organic impurities.

Complies

Assay

98.0% ~ 102.0%( On the anhydrous basis)

99.3%

Heavy metals

≤0.002%

＜0.002%

Limit of Ionic compounds

≤0.001%

0.00%

Limit of free iodide

≤0.001%

0.000%

 Organic impurity (HPLC)

 O-alkylated compounds ≤0.6%

＜0.5%

 Any individual impurity ≤0.1%

0.0%

Total impurities excluding Oalkylated compounds ≤0.3%

0.0%

Residual solvents(GC)

 2-Methoxyethanol ≤0.002%

＜0.002%

 Methanol ≤0.005%

0.000%

 N-butanol ≤0.005%

＜0.005%

3-Chloro-1,2-propanediol(GC)

≤0.0025%

＜0.0025%

Free aromatic amine

≤0.05%

0.01%

 Color of Solution

400nm≤0.180

0.123

420nm≤0.30

0.007

450nm≤0.015

0.001

Water

≤4.0%

1.5%

Bacterial endotoxins

≤0.003EU/mg

＜0.001EU/mg

Microbial limit

Total Aerobic Microbial Count ≤100cfu/g

＜10cfu/g

＜10cfu/g

Conclusion

The batch has been tested as above and confirms to the latest USP.

 The batch was manufactures according to Proper Manufacturing Practices.