
COA Of Tranexamic Acid
|
Item |
Standard |
Results |
|
Characteristics |
White Or Almost White, Crystalline Powder |
White Crystalline powder |
|
Solubility |
Freely Soluble In Water And In Glacial acetic Acid, Pratically Insoluble In Acetone and 96% Alcohol |
Complies |
|
Identification |
Infrared Absorption Atlas Consistent With the Contrast Atlas |
Complies |
|
Clarity And Color |
Solution Should Clarify And Colorless |
Complies |
|
Ph |
7.0-8.0 |
7.4 |
|
Related Substances Liquid Chromatography (2.29) |
Impurity A: ≤0.1% |
0.012% |
|
|
Impurity B: ≤0.2% |
0.112% |
|
|
Any Other Impurity: ≤0.1% |
<0.034% |
|
|
All Other Impurity: ≤0.2% |
<0.034% |
|
Chlorides |
≤140ppm |
<140ppm |
|
Heavy Metals |
≤10ppm |
<10ppm |
|
Loss On Drying |
≤0.5% |
0.3% |
|
Sulphate Ash |
≤0.1% |
0.04% |
|
Assay |
99.0%~101.0% |
99.8% |
|
Conclusion |
Complies With BP2013 Specification. |
|