Item

Specification

Test Results

Characteristics

White or almost white crystals or crystalline powder

Conform

Identification

Correspond to Tranexamic acid CRS

Conform

Solubility

Freely soluble in water and in glacial acetic acid practically insoluble in acetone and 96% ethanol

Conform

PH

7.0—8.0

7.40

Chloride

≤140ppm

<140ppm

Sulphated ash

≤0.1%

0.04%

Heavy Metals

≤10ppm

<10ppm

Loss on drying

≤0.5%

0.06%

 Arsenic

≤2ppm

＜2ppm

Related substances（HPLC）

Impurity A : ≤ 0.1%

Not detected

Impurity B: ≤ 0.2%

0.03%

Impurity C: ≤ 0.1%

0.036%

Impurity D: ≤ 0.1%

0.09%

Unspecified impurities≤0.1%

Not detected

Sum of unspecified impurities≤0.2%

Not detected

Total impurity≤0.5%

0.1%

Content

99.0%——101.0%

99.9%