Molecular Formula | C42H80NO8P |
Melting Point | 236.1ºC |
Solubility | Soluble in chloroform, ether, petroleum ether, insoluble in acetone. |
Appearance | Yellow solid |
Storage Condition | 2-8 ℃, stored in nitrogen |
Sensitive | Stable, but `sensitive` to light, heat, humidity and gas. Incompatible with strong oxidant |
soybean phospholipid is a mixture of phospholipids obtained by extracting and refining from soybean. Calculated as anhydrous, the phosphorus content should not be less than 2.7%; The nitrogen content should be 1.5% ~ 2 .0%; Containing phosphatidylcholine should not be less than 45.0%, containing phosphatidylethanolamine should not be more than 30.0%, containing phosphatidylcholine and phosphatidylethanolamine total not less than 70%.
The acid value of this product should not be greater than 3 0 (General Rule 0 7 1 3).
The iodine value of this product should not be less than 75 (General 0713).
The peroxide value of this product should not be greater than 3. 0 (General 0713).
take an appropriate amount of this product and add ethanol to make a solution containing 6mg per lm l. UV-visible spectrophotometry (General rule 0401), measured at the wavelength of 350nra absorbance, not over 0 .8.
take this product l . O g, precision weighing, adding about 15 m l of acetone, stirring to dissolve it, filtering with G 4 vertical melting glass crucible, washing with acetone for residual flooding, it was washed until acetone was almost colorless. The residue is dried to constant weight at 1 0 5°C and the insolubles shall not be less than 90.0%.
take 10.0g of this product, weigh precisely, add n-hexane 1 0 0M l, shake to dissolve the sample, filter with a G4 vertical melting glass crucible that has been previously dried at 105 ° C. For 1 hour and weighed, wash the Erlenmeyer flask twice with 25ml of n-hexane, filter the washing solution, and place the G 4 vertical melting glass crucible at 1051: dry for 1 hour and weigh, insoluble matter shall not pass 0 .3%.
take an appropriate amount of this product, according to the determination method of moisture (General rule 0832 first method), the water content shall not exceed 1 .5%.
take this product l.O g, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 20 parts per million.
take this product l . O g was placed in 1 0 m l standard grinding Erlenmeyer flask, 5 m l sulfuric acid was added, and the mixture was heated until the sample was carbonized, and concentrated hydrogen peroxide solution was added dropwise until the reaction was stopped, add concentrated hydrogen peroxide solution Dropwise until the solution is colorless, add water 1 0 m l After cooling, evaporate until the thick smoke disappears, check according to law (General Rule 0 8 2 2 second law), should comply with the regulations (0 .0 0 0 2).
take this product O. lg, precision weighing, set in Polytetrafluoroethylene digestion tank, add nitric acid 5 ~ 10ml, mix, soak overnight, cover the inner cover, tighten the jacket, and place the appropriate Microwave digestion furnace for digestion. After complete digestion, take the digestion tank and place it on the electric heating plate to slowly heat until the brown-red vapor is volatilized and nearly dried. 2% nitric acid was transferred to a 10ml volumetric flask and used with 0. Dilute to scale with 2% nitric acid, shake well, and use as test solution. The reagent blank solution was prepared by the same method; An appropriate amount of lead single element standard solution was taken and diluted with 0.2% nitric acid to prepare a reference solution containing 0-lOOng of lead per lm l. Take the test and reference solution, with graphite furnace as the atomizer, according to Atomic Absorption Spectrophotometry (General Rule 0 4 0 6 first method), in 283. 3mn at the wavelength of the determination of lead should not exceed two parts per million.
take 0.2g of this product and set it in a 20m l headspace bottle, add 2ml of water and seal it as a test solution. Accurately weigh an appropriate amount of ethanol, acetone, diethyl ether, petroleum ether and n-hexane, add water to dissolve and dilute to make the solvent containing about 20 0kun and 20 0Mg per lm l respectively, 2 0 0, 5 0mg, 2 7mg solution, as a solution. Test as residual solvent assay (General 0861). Capillary column HP-PLOT/Q,0. 53 mmX30mX40jLtm), flame ionization detector (F ID ) ; The inlet temperature is 2 5 0 1, the detector temperature is 260°C; The column temperature is temperature programmed, the initial temperature was maintained at 160°C for 8 minutes, and the temperature was raised to 190°C at a rate of 5°C per minute for 6 minutes; The split ratio was 20: 1. Nitrogen flow rate: 2m μ/m ir u headspace temperature 8 0 1, Headspace time 45 minutes, injection volume is lm l. The degree of separation between chromatographic peaks shall meet the requirements. According to the external standard method to calculate the peak area, this product contains ethanol, acetone, ether are not allowed to pass 0 .2%, containing petroleum ether should not pass 0.0 5 % , containing n-hexane should not exceed 0.02%, total residual solvent should not pass 0 .5%.
take this product and check it according to law (General rule 1 1 0 5 and general rule 1 1 0 6). The total number of aerobic bacteria per l g of sample shall not pass lO O d u, the total number of molds and yeasts shall not pass lO O c f u, and Escherichia coli shall not be detected; Salmonella shall not be detected in every 10g of test article.
preparation of control solution precision weighing potassium dihydrogen phosphate control dried to constant weight at 105°C. 0, 4, 3, 9G, put it in a 50ml measuring flask, add water to dissolve and dilute to the scale, shake well, take 10ml accurately, put it in another 50ml measuring flask, dilute it to the scale with water, shake well (l per lm is equivalent to 0. 04mg of the peptide).
take about 0.1 5 g of this product, weigh it accurately, put it in a Kjeldahl Flask, add 20ml of sulfuric acid and 50ml of nitric acid, slowly heat it until the solution is light yellow, carefully add hydrogen peroxide solution dropwise, the solution was allowed to fade, and heating was continued for 30 minutes. After cooling, the solution was transferred to a 100ml measuring flask, diluted to the mark with water, and shaken.
2ml of reference solution and 2ml of test solution were placed in 50ml measuring flask respectively, and 4ml of human ammonium molybdate and sulfuric acid solution was added in turn, sodium sulfite solution 2 m l and freshly prepared hydroquinone solution (hydroquinone 0. 5G, add appropriate amount of water to dissolve, add 1 drop of sulfuric acid, dilute to 100ml)2ml with water, dilute to the scale with water, shake, and place in the dark for 40 minutes, according to UV-visible spectrophotometry (General Rule 0 4 0 1 ) , the absorbance was measured at the wavelength of 620mn, and the phosphorus content was calculated.
take this product O . l g, precision weighing, according to the nitrogen determination method (General rule 07CH) determination, calculation. Phosphatidylcholine and phosphatidylethanolamine contents were determined by HPLC (General 0512).
using silica gel as a filler (column Alltima silica, 250mm x 4. 6mm × 5 μm), column temperature 40 * C; Methanol-water-glacial acetic acid-triethylamine (85 : 15 : 0. 45 : 0 .05,V /V) as mobile phase A, n-hexane-isopropanol-mobile phase A(20 : 48 : 32, V /V) as mobile phase B; The flow rate was lm l per minute; the gradient elution was carried out according to the following table; The detector was an evaporative light scattering detector (reference conditions: drift tube temperature 72 * ~; Carrier gas flow 2.0ml per minute).
Take appropriate amounts of phosphatidylethanolamine, phosphatidylinositol, lysophosphatidylethanolamine, phosphatidylcholine and lysophosphatidylcholine, and use three gas methane-methanol (2:1). Dissolve and make a mixed solution containing 50mg, 100, 100, 200F g, 200 and 200 of the above reference substance per lm l, inject the above solution 20 I 1 into the liquid chromatograph, and the components are eluted in the above order, and the separation degree of each component should be in accordance with the regulations. The number of theoretical plates is based on the peak of phosphatidylcholine and phosphatidylethanolamine, phosphatidylinositol should be calculated to be not less than 1500.
Take appropriate amount of phosphatidylethanolamine and phosphatidylcholine respectively, weigh them precisely, and dissolve them with three gas methane-methanol (2:1), the contents of Phosphatidylcholine in each lm l prepared by dilution are 5 0 dB, 1 0 0mg, 1 5 0 WT, 2 0 0 WT, 3 0 0mg and 4 0 T, respectively, the solutions containing phosphatidylethanolamine 5 mesh, 10 t, 1 5W, 2 0W and 3 0W were used as the reference solution. Accurately measure the above reference solution and inject 20 ^ 1 into the human liquid chromatograph, record the chromatogram, and calculate the regression equation with the logarithmic value of the concentration of the reference solution and the corresponding peak area, another precision weigh the product about 15 m g, put 50ml measuring flask, add three gas methane-methanol (2:1) dissolved and diluted to the scale. 20M1 of the test solution was injected into the liquid chromatograph, the chromatogram was recorded, and the contents of phosphatidylcholine and phosphatidylethanolamine were calculated by the regression equation.
oral pharmaceutical excipients, emulsifiers, solubilizers, etc.
sealed, protected from light, low temperature (a 186C below) storage.