Tranexamic Acid Whitening And Moisturizing Powder Skin Protection Medical Grade

Chemical Properties White or almost white, crystalline powder.

Uses Antifibrinolytic agent; blocks lysine binding sites of plasminogen. Hemostatic.

Uses Used as lysine analogue to characterize binding sites in plasminogen

Uses Fibrinolysis, the cleavage of fibrin by plasmin, is a normal step in the dissolution of fibrin clots after wound repair. Tranexamic acid is an inhibitor of fibrinolysis that blocks the interaction of plasmin with fibrin (IC50 = 3.1 μM). It is a lysine mimetic that binds the lysine binding site in plasmin. Antifibrinolytic agents have value when fibrinolytic activity is abnormally high or when coagulation is impaired.

 

 

 

Tranexamic acid, also known as coagulation acid, is chemically known as reverse-4-aminomethylcyclohexane formic acid. It is a white crystalline powder. No smell, slightly bitter taste. It is soluble in water and almost insoluble in ethanol, acetone, trichloromethane, or ether. The molecular formula is C8H15NO2, the molecular weight is 157.21000, the density is 1.095 g/cm3, the melting point is 233 C, the boiling point is 300.2 C at 760 mmHg.

 

Pharmacopoeia standard

Main chemical composition

This product is anti - -4- aminomethylcyclohexane formic acid. The content of C8H15NO2 shall not be less than 99.0% as per dry product.

character

White crystalline powder; No smell, slightly bitter taste.

It is soluble in water and almost insoluble in ethanol, acetone, trichloromethane, or ether.

To identify

(1) take about 0.1g of the product, add 5ml of water and dissolve it, add about 10mg of indenhydrin, heat it and gradually show bluish purple.

(2) the infrared absorption spectrum of the product shall be consistent with the control spectrum (figure 409 of the pharmaceutical infrared spectrum set).

check

alkalinity

Take 0.5g of this product, dissolve it with 10ml of water, and measure it according to law. The pH value should be 7.0 ~ 8.0.

Clarity and color of solution

Take 1.0g of this product, add 20ml of water and dissolve, the solution should be clear colorless.

chloride

Take 0.50g of this product, check according to law, and compare with the control solution made of standard sodium chloride solution 7.0ml, not more concentrated (0.014%).

sulfate

Take 0.50g of this product and check in accordance with the law. It shall not be thicker (0.07%) than the control solution made of 3.5ml of standard potassium sulfate solution (for oral or injection use) or thicker (0.04%) than the control solution made of 2.0ml of standard potassium sulfate solution (for intravenous infusion use).

About the material

Take this product, dissolve it with water and dilute it quantitatively to make a solution containing about 10mg tranexamic acid per 1ml as the sample solution. For precise measurement, take 1ml and put it into a 200ml measuring bottle, dilute it with water to the scale, and shake it well as the control solution. According to high performance liquid chromatography (2 2010 edition pharmacopoeia appendix Ⅴ D) test, using octadecyl silane bonded silica as filler, with 0.23% sodium dodecyl sulfate solution (sodium dihydrogen phosphate 18.3 g, water 800 ml dissolved, plus 8.3 ml triethylamine blending, add 2.3 g sodium dodecyl sulfate, vibration wave to dissolve, with phosphoric acid to adjust pH value to 2.5, add water to 1000 ml, shake) - methanol (60:40) as mobile phase, detection wavelength of 220 nm. Tranexamic acid and tranexamic acid were dissolved in water and diluted to make a solution containing 0.2mg of tranexamic acid and 2 g of tranexamic acid in 1ml, and 20 l was injected into a liquid chromatograph to adjust the flow rate, so that the retention time of tranexamic acid peak was about 13 minutes. The separation degree of tranexamic acid peak and tranexamic acid peak should be greater than 5.0. A control solution of 20 l was taken and injected into the liquid chromatograph to adjust the detection sensitivity so that the peak height of the main component chromatographic peak was about 10% of the full range. The sample solution and the control solution were then injected into the liquid chromatograph at a precise volume of 20 l each, and the retention time from the chromatogram to the main peak was recorded at 3 times. If there are impurity peaks in the sample solution chromatogram, the peak area of cycloolefin impurities with a retention time of about 1.2 times the correction factor of 0.005 shall not be greater than 0.2 times (0.1%) of the main peak area of the control solution. The peak area of aminotoluenic acid multiplied by the correction factor 0.006 shall not be greater than 0.2 times (0.1%) of the main peak area of the control solution. Relative retention time of about 1.5 Z - isomer peak area multiplied by the correction factor of 1.2, 0.4 times shall not be greater than the main peak area of reference solution (0.2%), and other individual impurity peak area shall not be greater than the main area is 0.2 times that of the reference solution (0.1%), olefin, aminomethylbenzoic acid, Z - isomer peak area respectively after multiplied by the correction factor and other impurity peak area and shall not be greater than the main peak area of reference solution (0.5%).

Easy carbon

This product is 0.50 g, in accordance with the inspection department ii (2010 edition pharmacopoeia appendix Ⅷ O), such as color, and contrast fluid [diluted 1 times of yellow or orange color liquid 1 (2 2010 edition pharmacopoeia appendix Ⅸ A first method)], shall not be deeper.

Dry weight loss

Take this product, dry at 105℃ to constant weight, weight loss must not exceed 0.5%.

On ignition residue

Take 1.0g of the product and inspect it according to law. The residual residue shall not exceed 0.1%.

Barium salt

Take 1.0g of this product, add 20ml of water and dissolve it (if the solution is not clarified, filter it), divide it into 2 equal parts: one part add 1ml of dilute sulfuric acid; Add 1ml water to the other portion and let stand for 15 minutes. The two liquids should be clarified as well.

Heavy metal

Take the residue left under the burning residue, check according to law, the heavy metal shall not exceed 10 parts per million.

Content determination

Take about 0.12g of this product, accurately weigh it, dissolve it with 40ml glacial acetic acid, add 1 ~ 2 drops of crystal violet indicator liquid, titrate with perchloric acid titrant (0.1mol/L) until the solution turns blue-green, and correct the titration result with blank test. Each 1ml of perchloric acid titrant (0.1mol/L) is equivalent to 15.72mg of C8H15NO2.