Raw Material Tranexamic Acid

Items of Test

Standard as per BP2017

Result

CHARACTERS

Appearance: White or almost white, crystalline powder

Positive

Solubility: Freely soluble in water and in glacial acetic acid, practically insoluble in acetone and in alcohol (96%).

Positive

IDENTIFICATION

Infrared Absorption Spectrophotometry (2.2.24): IR spectrum is in concordance with Tranexamic acid CRS

Positive

PH (2.2.3)

0.05g/ml aqueous (carbon dioxide free water) solution, 7.0 to 8.0

7.3

Related substances

Liquid chromatography

(2.2.29)

Impurity A: NLT 0.1%

< 0.10%

Impurity B: NLT0.2%

< 0.20%

Unspecified impurities NLT0.10%

< 0.10%

Sum of unspecified impurities NLT 0.2%

< 0.20%

Chlorides (2.4.4)

NLT140ppm

< 140ppm

Heavy metals (2.4.8)

NLT 10ppm

< 10ppm

Loss on drying (2.2.32)

NLT 0.5%

0.3%

Sulphated ash (2.4.14)

≤ 0.1%

<0.1%

ASSAY

(titration 2.2.20)

99.0% - 101.0% of C8H15NO2 (dried)

99.6%