Tianeptine sodium NEW

batch No.

202005001

Mfg. date

20200506

CAS No.

30123-17-2

Exp. date

20220505

Tests

Results

Specifications

Description

Off-white powder,very hygroscopic.

White to yellowish powder,very hygroscopic.

Solubility

Complies

Freetly soluble In water and methanol and dichloromethane

Identification

Complies

（1）By IR, To match with working standard

Complies

（2）It  gives reaction of sodium

Impurities A

Not  detected

≤0.1%

Related compounds

＜0.1%

Any  impurity   ≤0.1%

0.19%

Total impurities   ≤0.4%

Residual Solvents

Not detected

Acetidin ≤ 0.5%

0.04%

Dichloromethane≤ 0.06%

0.01%

Methanol≤ 0.3%

0.01%

Acetone ≤ 0.5%

Not detected

Acetonitrile≤0.041%

0.01%

Ethanol≤0.5%

Not detected

N, N-dimethylformamide ≤0.088%

Water

2.35%

≤ 5.0%

Assay

99.35%

99.0%-101.0%（On anhydrous basis）

Conclusion： Conform to EP8.0