Soybean phospholipids and Egg yolk lecithin
Soybean phospholipids are a mixture of phospholipids extracted and refined from soybeans, mainly composed of phosphatidylcholine, phosphatidylethanolamine, and small amounts of phosphatidylinositol, phosphatidic acid, etc.
It has physiological functions such as lowering blood lipids, antioxidation, regulating immune function, protecting the liver, anti-cancer (able to inhibit cancer cell growth), and improving memory. It is a natural amphoteric surfactant with good emulsifying, dispersing, wetting, instant dissolving, demolding, and separation effects. It is widely used in industries such as medicine, food or health food, cosmetics, etc.
In the pharmaceutical industry, it is mainly used as an emulsifier for drug emulsification, as a liposome membrane material for preparing liposomes, or as a stabilizer for suspensions, gas dispersants, solid dispersants and other drugs, which helps to stabilize, disperse and absorb drugs.
In the food industry, as a food additive, it plays a role in emulsification, antioxidant and other functions.
In the field of health products, it has the effects of regulating blood lipids and improving memory.
In the cosmetics industry, it can be used to improve the moisturizing properties of the skin.
This product is divided into industrial grade, medicinal oral grade, and medicinal injection grade according to its use;
According to the content of phosphatidylcholine (PC), there are PC50, PC60, PC70, PC80, PC90, etc.
1.Soybean phospholipid (industrial grade):
| Inspection items |
Standard regulations |
Product Description |
| PC50 |
PC60 |
PC70 |
PC75 |
PC90 |
| Appearance color |
Yellow to Brown |
Yellow to Brown |
| Odor |
Has a unique odor of phospholipids and no peculiar smell |
Has a unique odor of phospholipids and no peculiar smell |
| Trait |
Viscous liquid, paste like, powder like, granular or block like |
Viscous liquid, paste like, powder like, granular or block like |
| Phosphatidylcholine(PC)，w/% |
/ |
≥50 |
≥57 |
≥69 |
≥75 |
≥87 |
| Acetone Insoluble Content ，w/% |
≥60 |
≥90 |
| Loss on drying，w/% |
≤2.0 |
≤2.0 |
| N-hexane insoluble substance，w/% |
≤0.3 |
≤0.3 |
| Acid value,mgKOH/g |
≤36.0 |
≤36.0 |
| Peroxide Value/(mmol/kg) |
≤5.0 |
≤5.0 |
| Residual solvent |
Ethanol residue，％ |
≤0.2 |
≤0.2 |
| Acetone residue，％ |
≤0.2 |
≤0.2 |
| Residual ether，％ |
≤0.2 |
≤0.2 |
| Petroleum ether residue，％ |
≤0.05 |
≤0.05 |
| Residual n-hexane，％ |
≤0.02 |
≤0.02 |
| Total residual solvents，％ |
≤0.5 |
≤0.5 |
Note: 1) Implementation standards: PC and Residual solvents refer to "Chinese Pharmacopoeia Soybean Phospholipids [8030-76-0]", and other inspection items refer to "National Food Safety Standard Food Additive Phospholipids" GB1886.358-2022 or customer agreement standards;
2) Packaging specifications: 1KG/bag, 5KG/bag, 7.5 KG/bag or packaging according to customer requirements;
3) Storage conditions: sealed, away from light, stored at low temperature (below -18 ℃);
4) Validity period: 12 months. |
2、Soybean phospholipid (medicinal grade):
| Inspection items |
Standard regulations |
Product Description |
| PC50 |
PC60 |
PC70 |
| Trait |
Appearance and characteristics |
This product is a semi-solid, block like substance of Yellow to Brown, which is soluble in ether or ethanol and insoluble in acetone. |
This product is a semi-solid, block like substance of Yellow to Brown, which is soluble in ether or ethanol and insoluble in acetone. |
| Acid value, mgKOH/g |
≤30 |
≤25 |
| Iodine value, gI/100g |
≥75 |
≥80 |
| Peroxide Value，meq/kg |
≤3.0 |
≤3.0 |
| Identify |
⑴ Chemical reaction |
Positive reaction |
Positive reaction |
| ⑵ Chemical reactions |
Positive reaction |
Positive reaction |
| Detection |
Color of the solution (absorbance at 350nm wavelength) |
≤0.8 |
≤0.7 |
| Acetone Insoluble Content ，w/% |
≥90.0 |
≥90.0 |
| Hexane insoluble substance, w/% |
≤0.3 |
≤0.3 |
| water content, w/% |
≤1.5 |
≤1.5 |
| Heavy metals, w/% |
≤0.002 |
≤0.001 |
| Arsenic salts, w/% |
≤0.0002 |
≤0.0002 |
| Lead, w/% |
≤0.0002 |
≤0.0002 |
| Residual solvent |
Ethanol, w/% |
≤0.2 |
≤0.2 |
| Acetone, w/% |
≤0.2 |
≤0.2 |
| Ether, w/% |
≤0.2 |
≤0.2 |
| Petroleum ether, w/% |
≤0.05 |
≤0.05 |
| N-hexane, w/% |
≤0.02 |
≤0.02 |
| Total Resident Solution, w/% |
≤0.5 |
≤0.4 |
| microbial limit |
Total aerobic bacteria count cfu/g |
≤102 |
≤102 |
| Total number of mold and yeast cfu/g |
≤102 |
≤102 |
| Escherichia coli/g |
not detectable |
not detectable |
| Salmonella/10g |
not detectable |
not detectable |
| Content determination (based on anhydrous substance) |
Phosphorus content, w/% |
≥2.7 |
≥2.7 |
| Nitrogen content, w/% |
1.5～2.0 |
1.5～2.0 |
| PC and PE content |
PC，w/% |
≥45.0 |
≥50.0 |
≥57.0 |
≥68.0 |
| PE，w/% |
≤30.0 |
≤30.0 |
| PC+PE，w/% |
≥70 |
≥70 |
≥70 |
≥75 |
Note: 1) Implementation standard: "Chinese Pharmacopoeia Soybean Phospholipids [8030-76-0]";
2) Packaging specifications: 1KG/bag, 5KG/bag, 7.5 KG/bag or packaging according to customer requirements;
3) Storage conditions: sealed, away from light, stored at low temperature (below -18 ℃);
4) Validity period: 12 months 。 |
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3，Soybean phospholipids (for injection):
| Inspection items |
Standard regulations |
Product Description |
| PC70 |
PC80 |
PC90 |
| Trait |
Appearance and characteristics |
This product is a semi-solid, block like substance of Yellow to Brown. This product is soluble in ether or ethanol and insoluble in acetone. |
This product is a semi-solid, block like substance of Yellow to Brown. This product is soluble in ether or ethanol and insoluble in acetone. |
| Acid value, mgKOH/g |
≤30 |
≤15 |
| Iodine value, gI/100g |
≥75 |
85-110 |
| Peroxide Value，meq/kg |
≤3.0 |
≤3.0 |
| Identify |
⑴ Chemical reaction |
Immediately produce white precipitate |
Compliance |
| ⑵ Chemical reactions |
Immediately generate brick red sediment |
Compliance |
| ⑶ Liquid phase diagram |
In the chromatogram recorded under the content determination items of phosphatidylcholine (PC) and phosphatidylethanolamine (PE), the retention time of the main peak of the test solution should be consistent with that of the reference solution. |
Compliance |
| Detection |
Color of the solution (absorbance at 350nm wavelength) |
≤0.8 |
≤0.7 |
| Acetone Insoluble Content ，w/% |
≥90.0 |
≥90.0 |
| Hexane insoluble substance, w/% |
≤0.3 |
≤0.3 |
| water content, w/% |
≤1.5 |
≤1.5 |
| protein |
The solution should not be blue purple or reddish purple in color
|
Compliance |
| Heavy metals, w/% |
≤0.0005 |
≤0.0005 |
| Arsenic salts, w/% |
≤0.0002 |
≤0.0002 |
| Lead, w/% |
≤0.0002 |
≤0.0002 |
| Residual solvent |
Ethanol, w/% |
≤0.2 |
≤0.2 |
| Acetone, w/% |
≤0.2 |
≤0.2 |
| Ether, w/% |
≤0.2 |
≤0.2 |
| Petroleum ether, w/% |
≤0.05 |
≤0.05 |
| N-hexane, w/% |
≤0.02 |
≤0.02 |
| Total Resident Solution, w/% |
≤0.5 |
≤0.4 |
Regarding substances |
LPE，w/% |
≤1 |
≤1 |
| LPC，w/% |
≤3.5 |
≤3.5 |
| LPC+LPE，w/% |
≤4.0 |
≤4.0 |
| PI，w/% |
≤5.0 |
≤5.0 |
| Total related substances, w/% |
≤8.0 |
≤8.0 |
| microbial limit |
Total aerobic bacteria count cfu/g |
≤102 |
≤102 |
| Total number of mold and yeast cfu/g |
≤102 |
≤102 |
| Escherichia coli/g |
not detectable |
not detectable |
| Salmonella/10g |
not detectable |
not detectable |
| Bacterial endotoxins, EU/g |
＜2.0 |
＜2.0 |
| Content determination (based on anhydrous substance) |
Phosphorus content, w/% |
≥2.7 |
≥3.3 |
| Nitrogen content, w/% |
1.5～2.0 |
1.5～2.0 |
| PC、PE content |
PC，w/% |
≥45.0 |
≥70.0 |
≥78.0 |
≥88.0 |
| PE，w/% |
≤30.0 |
≤18.0 |
| PC+PE，w/% |
≥70 |
≥75 |
≥80 |
≥90 |
Note:
1) Implementation standard: "Chinese Pharmacopoeia Soybean Phospholipids (for Injection) [8030-76-0]";
2) Packaging specifications: 1KG/bag, 5KG/bag, 7.5 KG/bag or packaging according to customer requirements;
3) Storage conditions: sealed, away from light, stored at low temperature (below -18 ℃);
4) Validity period: 24 months. |
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4、Egg yolk lecithin (for injection):
| Inspection items |
Standard regulations |
Product Description |
| PC70 |
PC80 |
| Trait |
Appearance |
This product is a milky white or light yellow powder or waxy solid with a slight distinctive odor. This product is soluble in ethanol, ether, chloroform, or petroleum ether (boiling range 40-60 ℃), and is almost insoluble in acetone and water. |
This product is a milky white or light yellow powder or waxy solid with a slight distinctive odor. This product is soluble in ethanol, ether, chloroform, or petroleum ether (boiling range 40-60 ℃), and is almost insoluble in acetone and water. |
| Acid value, mgKOH/g |
≤20.0 |
≤15.0 |
| Saponification value, mgKOH/g |
195～212 |
195～212 |
| Iodine value, gI/100g |
60～73 |
63～73 |
| Peroxide Value，meq/kg |
≤3.0 |
≤2.0 |
| Identify |
chemical reaction |
The generated gas can turn wet red litmus paper blue |
Compliance |
| chemical reaction |
Should be yellow green in color |
Compliance |
| Liquid phase diagram |
In the chromatogram recorded under the content determination items of phosphatidylcholine (PC) and phosphatidylethanolamine (PE), the retention time of the main peak of the test solution should be consistent with that of the reference solution. |
Compliance |
| Detection |
Free fatty acids, w/% |
≤1 |
≤1 |
| Triglycerides, w/% |
≤3 |
≤3 |
| cholesterol, w/% |
≤2 |
≤2 |
| Palmitic acid, w/% |
≤0.2 |
≤0.2 |
| Regarding substances |
PI，w/% |
≤5.0 |
≤5.0 |
| LPE，w/% |
≤1 |
≤1 |
| SPM，w/% |
≤3.0 |
≤3.0 |
| LPC，w/% |
≤3.5 |
≤3.5 |
| LPC+LPE，w/% |
≤4.0 |
≤4.0 |
| Including the total amount of the above-mentioned substances, w/% |
≤8.0 |
≤8.0 |
| Residual solvent |
Ethanol, w/% |
≤0.2 |
≤0.2 |
| Acetone, w/% |
≤0.2 |
≤0.2 |
| Ether, w/% |
≤0.2 |
≤0.2 |
| Petroleum ether, w/% |
≤0.05 |
≤0.05 |
| N-hexane, w/% |
≤0.02 |
≤0.02 |
| Total Resident Solution, w/% |
≤0.5 |
≤0.5 |
| water content, w/% |
≤3 |
≤1.5 |
| protein |
The solution should not be blue purple or reddish purple in color |
Compliance |
| Heavy metals, w/% |
≤0.0005 |
≤0.0005 |
| Arsenic salts, w/% |
≤0.0002 |
≤0.0002 |
| Bacterial endotoxin EU/g |
＜2.0 |
＜2.0 |
microbial limit |
Total aerobic bacteria count cfu/g |
≤102 |
≤102 |
| Mold and yeast cfu/g |
≤102 |
≤102 |
| Escherichia coli/g |
not detectable |
not detectable |
| Salmonella/10g |
not detectable |
not detectable |
| Content determination (calculated as anhydrous substance) |
Phosphorus content, w/% |
3.5～4.1 |
3.5～4.1 |
| Nitrogen content, w/% |
1.75～1.95 |
1.75～1.95 |
| PC、PE content |
PC，w/% |
≥68.0 |
≥68.0 |
≥75.0 |
| PE，w/% |
≤20.0 |
≤20.0 |
≤15.0 |
| PC+PE，w/% |
≥80 |
≥80 |
≥80 |
Note: 1) Implementation standard: "Chinese Pharmacopoeia Egg Yolk Phosphatidylcholine (for Injection) [93685-90-6]";
2) Packaging specifications: 1KG/bag, 5KG/bag, 7.5 KG/bag or packaging according to customer requirements;
3) Storage conditions: sealed, away from light, stored at low temperature (below -18 ℃);
4) Validity period: 24 months. |
If you have any needs, please feel free to consult: pangjun@costones.com
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