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Soybean Phosphatidylcholine (for injection) (CAS:8030-76-0)

Soybean Lecithin (for Injection) is a pale yellow waxy product refined and purified from powdered lecithin as raw material through processes such as ethanol extraction. Its purity can be enhanced up to 98%; however, higher purity corresponds to stronger oxidative properties, so it is generally required to be stored in nitrogen-filled sealed containers. Pure lecithin is a colorless and odorless white solid at room temperature, but it may appear in shades ranging from pale yellow to brown due to differences in preparation or purification methods, as well as storage conditions.

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Product Description

Soybean Lecithin (for Injection) is a pale yellow waxy product refined and purified from powdered lecithin as raw material through processes such as ethanol extraction. Its purity can be enhanced up to 98%; however, higher purity corresponds to stronger oxidative properties, so it is generally required to be stored in nitrogen-filled sealed containers. Pure lecithin is a colorless and odorless white solid at room temperature, but it may appear in shades ranging from pale yellow to brown due to differences in preparation or purification methods, as well as storage conditions.
Product Specifications

Physicochemical Indicators
  PC-80 PC-90 PC-95 PC-98
Phosphorus (P) ≥2.7% ≥2.7% ≥2.7% ≥2.7%
Nitrogen (N) 1.5~2.0% 1.5~2.0% 1.5~2.0% 1.5~2.0%
Phosphatidylcholine (PC) ≥80% ≥90% ≥95% ≥98%
Phosphatidylethanolamine (PE) ≤30% ≤30% ≤30% ≤30%
Phosphatidylcholine and Phosphatidylethanolamine (PC+PE) ≥80% ≥90% ≥95% ≥98%
Acetone-insoluble substances ≥90% ≥90% ≥90% ≥90%
Lysophosphatidylethanolamine (LPE) ≤1% ≤1% ≤1% ≤1%
Lysophosphatidylcholine (LPC) ≤3.5% ≤3.5% ≤3.5% ≤3.5%
Lysophosphatidylethanolamine and Lysophosphatidylcholine (LPE+LPC) ≤4.0% ≤4.0% ≤4.0% ≤4.0%
Phosphatidylinositol (PI) ≤5.0% ≤5.0% ≤5.0% ≤5.0%
Total Related Substances ≤8.0% ≤8.0% ≤8.0% ≤8.0%
Hexane-insoluble substances ≤0.3% ≤0.3% ≤0.3% ≤0.3%
Water ≤1.5% ≤1.5% ≤1.5% ≤1.5%
Total Residual Solvents ≤0.5% ≤0.5% ≤0.5% ≤0.5%
Protein Not detectable Not detectable Not detectable Not detectable
Acid Value ≤30 ≤30 ≤30 ≤30
Iodine Value ≥75 ≥75 ≥75 ≥75
Peroxide Value ≤3.0 ≤3.0 ≤3.0 ≤3.0

 

Microorganisms, Bacterial Endotoxins
  PC-80 PC-90 PC-95 PC-98
Total Aerobic Bacteria Count ≤100cfu/g ≤100cfu/g ≤100cfu/g ≤100cfu/g
Total Mold and Yeast Count ≤100cfu/g ≤100cfu/g ≤100cfu/g ≤100cfu/g
Escherichia coli Not detectable per 1g Not detectable per 1g Not detectable per 1g Not detectable per 1g
Salmonella Not detectable per 10g Not detectable per 10g Not detectable per 10g Not detectable per 10g
Bacterial Endotoxins <2.0Eu/g <2.0Eu/g <2.0Eu/g <2.0Eu/g

 

Application Range:

Pharmaceutical Products Widely used in injectable preparations, liposome raw materials, and carbon fluoride emulsions.
High-end Cosmetics Emulsifier, co-emulsifier, skin feel softener, wetting agent, moisturizing, anti-aging

 

Storage Conditions and Shelf Life
Sealed, protected from light, stored at low temperature (-18℃ or below); shelf life 24 months

 

Implementation Standard
2020 edition of the Chinese Pharmacopoeia standard for Soybean Phosphatide (for injection)

 

 

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