| Product Info - Tranexamic acid | |
| Appearance | This product is white crystalline powder; odorless, slightly bitter taste. This product is easily soluble in water and almost insoluble in ethanol, acetone, chloroform or ether. |
| Identification | (1) Take about 0.1g of this product, add 5ml of water to dissolve it, add about 10mg of ninhydrin, heat it, and it gradually turns blue-purple. (2) The infrared absorption spectrum of this product should be consistent with that of the control (spectrum set 409). |
| Pharmacological action | Tranexamic acid, also known as tranexamic acid, chemical name 4-aminomethylcyclohexanecarboxylic acid, trade name Toxamine. Tranexamic acid is a synthetic amino acid antifibrinolytic drug, which can competitively inhibit the binding of lysine of fibrin to plasmin, thereby inhibiting the cleavage of fibrin clots and producing hemostasis. It is mainly used for fibrinolysis in clinic. All kinds of bleeding caused by hyperactivity. Tranexamic acid is a synthetic lysine that can competitively bind to the lysine binding sites on plasminogen and plasmin, thereby competitively inhibiting the degradation of fibrin and reducing fibrinolytic activity , play a procoagulant effect. Theoretically, the use of tranexamic acid can lead to insufficient fibrinolytic activity, which may lead to an increased risk of postoperative thrombotic events. |
| Inspection | Clarity and color of solution Take 1.0g of this product, add 20ml of water to dissolve, the solution should be clear and colorless. Take 0.50g of this product for sulfate, and check it according to the law (Appendix VIII b). Compared with the control solution made of 3.5ml of standard potassium sulfate solution, it should not be more concentrated (0.07%) (for oral or injection) or with standard potassium sulfate solution. Compared with the control solution made of 2.0ml, it should not be more concentrated (0.04%) (for intravenous infusion). Take about 20 mg of this product for the z-isomer, put it in a separatory funnel, dissolve it with 1.0 ml of 0.1 mol/l boric acid solution, and add 10% (g/ml) of 4-fluoro-3-nitro-trichlorotoluene. 40 ml of dimethyl sulfoxide solution, shake vigorously for 10 minutes, add 50 ml of 0.1 mol/l hydrochloric acid solution, shake well, extract twice with chloroform, 10 ml each time, combine the chloroform solutions, evaporate to dryness, and add to the residue Dissolve an appropriate amount of alcohol chloroform, transfer it to a 5ml measuring bottle, add alcohol-free chloroform to dilute to the mark, shake well, and use it as the test solution; accurately measure 1ml, put it in a 100ml measuring bottle, use alcohol-free chloroform Dilute methane to the mark, shake well, accurately measure 5ml, put it in a 50ml measuring bottle, dilute it to the mark with alcohol-free chloroform, shake well, and use it as a control solution. Measured according to high performance liquid chromatography (Appendix V d), with silica gel as filler; n-hexane-alcohol-free chloroform-glacial acetic acid (120:80:1) as mobile phase; detection wavelength is 420nm. The number of theoretical plates is not less than 2000 calculated according to the peak of e-tranexamic acid. Take 20 μl of the control solution and inject it into the liquid chromatograph, adjust the detection sensitivity, so that the peak height of the main component chromatographic peak is 10%-20% of the full scale; then precisely measure 20 μl of the test solution and the control solution, and inject them into the liquid phase respectively. Chromatograph, record the chromatogram. In the chromatogram of the test solution, the peak area of the adjacent peak before the main peak shall not be larger than the main peak area of the control solution (for oral administration or injection) or not larger than 4/5 times the main peak area of the control solution (for intravenous infusion). Take 0.10g of this product, dissolve it in water and dilute it to 100ml, measure the absorbance at the wavelength of 270nm according to UV-Vis spectrophotometry (Appendix IV a), the absorbance should not exceed 0.02 (for oral or injection) or not Over 0.01 (for intravenous infusion). Take 0.50g of this product for easy carbonization and check according to the law (Appendix Ⅷ o), if the color is developed, compare it with the control solution [Yellow-green or orange-yellow No. 1 colorimetric solution diluted 1 times with water (Appendix Ⅸ a first method)], No deeper. Weight loss on drying Take this product and dry it at 105℃ to constant weight, the weight loss should not exceed 0.5% (Appendix VIII l). Residue on ignition Take 1.0g of this product and inspect it according to the law (Appendix VIII n), and the residual residue should not exceed 0.1%. Take 1.0g of this product as barium salt, dissolve it in 20ml of water (if the solution is not clear, filter it), divide it into 2 equal parts: add 1ml of dilute sulfuric acid to one part; add 1ml of water to the other part, and let stand for 15 minutes. should be similarly clarified. Heavy metals Take the residues left under the item of residues on ignition and inspect them according to the law (Appendix VIIIh second method), and the heavy metals shall not exceed 10 parts per million. |
| Assay Test | Take about 0.25g of this product, accurately weigh it, add 40ml of glacial acetic acid to dissolve, add 1-2 drops of crystal violet indicator solution, titrate with perchloric acid titration solution (0.1mol/l) until the solution turns blue-green, and titrate The results were corrected with a blank test. Each 1ml of perchloric acid titration solution (0.1mol/l) is equivalent to 15.72mg of c8h15no2. |
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