噻奈普汀鈉鹽

Product

產(chǎn)品名稱

Tianeptine sodium

噻奈普汀鈉鹽

batch No.

批號

20191210

Mfg. date

生產(chǎn)日期

20191210

CAS No.

30123-17-2

Exp. date

有效期至

20211209

Tests

項目

Specifications

標準

Description

性狀

White to yellowish powder,very hygroscopic.

白色或淡黃色粉末，極易引濕

Solubility

溶解度

Freetly soluble In water and methanol and dichloromethane

在水、甲醇和二氯甲烷中易溶

Identification

鑒別

（1）By IR, To match with working standard

 IR圖譜應與對照品一致

（2）It  gives reaction of sodium

應顯鈉鹽的鑒別反應

Impurities A

雜質(zhì)A

             ≤0.1%

Related compounds

有關(guān)物質(zhì)

Any  impurity  任意雜質(zhì) ≤0.1%

Total impurities  總雜質(zhì) ≤0.4%

Residual Solvents

溶劑殘留

Acetidin乙酸乙酯≤ 0.5%

Dichloromethane二氯甲烷≤ 0.06%

Methanol甲醇≤ 0.3%

Acetone 丙酮≤ 0.5%

Acetonitrile乙腈≤0.041%

Ethanol乙醇≤0.5%

N, N-dimethylformamide N,N-二甲基甲酰胺≤0.088%

Water

水分

≤ 5.0%

Assay

含量

99.0%-101.0%（On anhydrous basis以干品計）

Conclusion 結(jié)論 ： Conform to EP8.0  本品符合EP8.0標準