Pharmaceutical-grade soybean phospholipid injection grade PC80 PC90 trial research and development

Pharmaceutical grade soybean phospholipid injection grade PC80 PC90 small test research and development of arsenic salt Take 1.
0g of this product placed in a 100ml standard grinding mouth Erlenmeyer flask, add 5ml of sulfuric acid, heat until the sample is carbonized, add concentrated hydrogen peroxide solution droplet, continue to heat after the reaction stops, add concentrated hydrogen peroxide solution dropwise until the solution is colorless, add 10ml of water after cooling, evaporate until the smoke disappears, check according to law (general rule 0822 second law), should comply with the provisions (0.
0002%)
.

Lead take 0.
1g of this product, precision weighing, placed in the polytetrafluoroethylene digestion tank, add 5 to 10ml of nitric acid, mix well, soak overnight, cover the inner cover, tighten the coat, place in the appropriate microwave digestion furnace, digestion
.

After the digestion is complete, cancel the canister and slowly heat it on the electric heating plate until the brown-red vapor is exhausted and nearly dry, transfer the 0.
2% nitric acid solution to the 10ml measuring bottle, and dilute it to the scale with 0.
2% nitric acid solution, shake well, as a test solution; Preparation of reagent blank solution by same method; Take an appropriate amount of lead single element standard solution, and quantitatively dilute with 0.
2% nitric acid solution to make a control solution
containing 0~100ng of lead per 1ml.

Take the test and control solution, take the graphite furnace as the atomizer, according to the atomic absorption spectrophotometry (general rule 0406 first method), measured separately at the wavelength of 283.
3nm, should comply with the provisions (0.
0002%)
.

Bacterial endotoxin Take this product, fully dissolve it in absolute ethanol, further dilute it with bacterial endotoxin inspection water to the desired concentration of the experiment (the ethanol concentration in the solution should be less than 20%), check according to law (general rule 1143), the amount of endotoxin contained in each 1g of soybean phospholipids should be less than 2.
0EU
.

Microbial limit Take this product, check according to law (General Rule 1105 and General Rule 1106), the total number of aerobic bacteria per 1g of test product shall not exceed 102cfu, the total number of molds and yeasts shall not exceed 102cfu, and Escherichia coli shall not be detected; Salmonella
should not be detected in every 10 g of the sample.

【Content determination】 Nitrogen take 0.
1g of this product, precise weighing, according to the nitrogen determination method (general rule 0704 second method) determination, calculation, that is, obtained
.

Preparation of phosphorus control solution Precision weigh 105 °C dried to constant weight potassium dihydrogen phosphate control 0.
0439g, placed in a 50ml measuring flask, dissolved in water and diluted to the scale, shake well, precision measurement 10ml, placed in a 50ml measuring bottle, diluted with water to the scale, shake well (per 1ml is equivalent to 0.
04mg of phosphorus).