Product Name | Tranexamic Acid | Batch Number | GW20220713A | ||
Quantity | 500kgs | Manufacture Date | Jul. 13, 2022 | ||
Expiry Date | Jul. 12, 2024 | Analysis Date | Jul. 13, 2022 | ||
Items | Specifications | Results | |||
Appearance | White crystalline powder | White crystalline powder | |||
Solubility |
Soluble in water and glacial acetic acid, almost not soluble in ethanol and acetone (96%) | Soluble in water and glacial acetic acid, almost not soluble in ethanol and acetone (96%) |
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Identification |
Infrared absorption map complies with the tranexamic acid comparison map | Infrared absorption map complies with the tranexamic acid comparison map | |||
PH | 7.0~8.0 | 7.1 | |||
Loss on drying | ≤0.5% | 0.06% | |||
Residue on ignition | ≤0.1% | 0.01% | |||
Heavy metals | ≤10ppm | <10ppm | |||
Sulphate ash | ≤0.1% | <0.03% | |||
Chloride | ≤140ppm | <140ppm | |||
Assay | 99.0%~101.0% | 99.97% | |||
Related substances | A≤0.1% | A=0.043% | |||
B≤0.2% C≤0.1% |
B=0.0608% C=0.009% |
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D≤0.1% | D=0.0051% | ||||
Total impurities(except A,B) ≤0.2% | Total impurities(except A,B)=0.015% |
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*Conclusion:This product conforms to requirements of USP Standard. |
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