塞纳普汀钠

Product

Tianeptine sodium

batch No.

15052908

Mfg. date

2015-05-29

Test Date

2015-06-02

Exp. date

2017-05-28

Tests

Specifications

Results

Description

White to yellowish powder,very hygroscopic.

Off-white powder,very hygroscopic.

Solubility

Freetly soluble In water and methanol and dichloromethane

Complies

Identification

(1)By IR, To match with working standard IR

Complies

(2)It  gives reaction of sodium

Complies

Impurities A

≤0.1%

Not  detected

Related compounds

Any  impurity ≤0.1%

0.07%

Total impurities   ≤0.4%

0.14%

Residual Solvents

Acetidin≤ 0.5%Not  

Not  detected

Dichloromethane≤ 0.06%

Not  detected

Methanol≤ 0.3%

0.02%

Acetone ≤ 0.5%

0.32%

Acetonitrile≤0.041%

  detected

Ethanol≤0.5%

0.01%

N, N-dimethylformamide ≤0.088%

Not  detected

Water

≤ 5.0%

2.41%

Assay

99.0%-101.0%(On anhydrous basis)

99.98%

       Conclusion  : Conform to EP8.0