ITEMS

SPECIFICATIONS

RESULTS

Description

White crystalline powder

White crystalline powder

Solubility

Freely soluble in water and in glacial acetic acid, practically insoluble in acetone and in alcohol.

Consistent with the standard

Identification

Infrared absorption spectrophotometry(2.2.24); IR spectrum is in concordance with tranexamic acid CRS

Consistent with the standard

pH

7.0~8.0

7.2

Related substances Liquid chromatography

(2.2.29)

Impurity A:≤0.1%

<0.1%

Impurity B:≤0.2%

<0.2%

Any other impurity :≤0.1%

<0.1%

All other impurity: ≤0.2%

<0.2%

Heavy metals

≤10ppm

<10ppm

Chlorides

≤140ppm

<140ppm

Loss on drying

≤0.5%

0.38%

Sulphated ash

≤0.1%

<0.10%

Assay(C8H15NO2)

99.0~101.0%

99.80%