| 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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