(1) Take this product and heparin sodium as standard, and mix with water to make a solution containing 2.5 mg per 1 ml. The electrophoresis experiment showed that the ratio of migration distance between the sample and the standard sample was 0.9ー1.1.
(2) The identification reaction of the phantom sodium salt in the aqueous solution of this product.
The pH value of this product is 0.10g, dissolved in 10ml water, determined according to law. The pH value should be 5.0 ~ 7.5. Clarification and color of solution: take 0.50g of this product and dissolve it in 10ml water. The solution should be clear and colorless. If it is turbidity, the absorbance determined by spectrophotometry at the wavelength of 640 nm is not more than 0.018.
When rendering, it must not be darker than the yellow standard 1 than the color solution. Take the absorbance of the product and mix it with water to make a solution containing 4 mg per 1 ml. According to the filament phosphorus method, the absorption of 260 nm wavelength should not be greater than 0.20 and 280 nm wavelength should not be greater than 0.15.
Viscosity, accurately according to the product (according to the measured data can be equivalent to 400000 units), add water to grind, moving 10 ml dry processing capacity of weighing, keep the bottle washing water system as well as the mortar, into a reaction inside the bottle capacity, will put in 25 ℃ water bath, volumetric flask temperature balance problem to join in balance after 25 ℃ water, shake well, Weighing and calculating the density of the test solution. The solution was filtered with a 0.45μm filter membrane when necessary. The dynamic viscosity at 25℃±0.1℃ was measured by a capillary with an inner diameter of about 1mm. The dynamic viscosity should not be greater than 0.030Pa
Total nitrogen content, take this product, according to the nitrogen content determination method. According to the dry product, the total nitrogen content should be 1.3 ~ 2.5.
About 25mg of sulfur was taken, accurately weighed and organically destroyed by oxygen cylinder combustion method. Choose a 1000ml Molotov bottle containing 0.3ml of hydrogen peroxide concentrate and 10ml of water as absorbent. After the smoke is completely absorbed, it is placed in an ice bath for 15 minutes, then heated, slowly boiled for 2 minutes, cooled and then added with 50ml ethanol-ammonium acetate buffer (pH3.7ml) and 30ml ethanol. Each 1 mL of barium perchlorate titration solution (0.05 mL/L) corresponds to 1.603 mg of sulfur, with a sulfur content of not less than 10.0 for dry products. Take out the product from the drying loss, put it into the phosphorus pentoxide dryer, and dry it to constant weight at 60℃ under reduced pressure. Weight loss should not exceed 5.0.
The above is how to identify and test heparin sodium by heparins manufacturer.