Pharmaceutical Excipients Egg Lecithin GMP Purified Egg Phospholipids
Contact Person : Jimmy Tian
Phone Number : 86-18602905046
WhatsApp : +8618602905046
| Minimum Order Quantity : | 4Kg | Packaging Details : | 4Kg in a bag |
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| Delivery Time : | 30 days | Payment Terms : | T/T, L/C |
| Place of Origin: | China | Brand Name: | LIBANG |
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| Certification: | Chinese GMP |
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Detail Information |
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| Quality Specification: | USP EP JP CP | Dossier: | DMF Available |
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| Storage: | Store At Below ~15℃ | PC: | 72.0~85.0% (E80) |
| High Light: | GMP Phosphatidylserine Egg Yolk,Phosphatidylserine Egg Yolk CAS 93685-90-6,93685-90-6 Lecithin Free Protein Powder |
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Product Description
Egg Phospholipids for injection Purified Egg Lecithin injectable grade USP EP CP CAS No.93685-90-6
Egg Phospholipids also known as Egg Lecithin, is a critical pharmaceutical excipient for producing injectable emulsion acted as an emulsifying agent.
Xi'an Libang Pharmaceutical Co..Ltd developed Egg Lecithin with superior quality in China and is applying Egg Phospholipid into our own emulsion products, such as Propofol Injection, LCT Fat Emulsion and MCT/LCT Fat Emulsion. The CP grade COA is displayed as follow:
| Tests | Specifications | Results | |
| Appearance | opalescent or light yellowish powder or waxy solid, greasy feeling. Quickly to turn to darker color and easy to agglomerate. |
Conforms | |
| Solubility | Easily soluble in ethanol,diethyl ether, trichloromethane or petroleum ether(40℃-60℃),slight soluble in acetone and insoluble in water. | Conforms | |
| Identification | chemical reaction 1:positive reaction | Conforms | |
| chemical reaction 2:positive reaction | Conforms | ||
| Identification 3::the retention time of the main peak of the sample solution should be consistent with that of the reference solution. | Conforms | ||
| Saponification Value | 195-212 | 206 | |
| Iodine Value | 65-73 | 70 | |
| Acid Avalue | 7-10 | 8 | |
| Peroxide Value | no more than 3 | Conforms | |
| Free fatty acids | The volume of sodium hydroxide VS consumed by test solution is not more than that consumed by reference solution | Conforms | |
| Triglyceride, cholesterol and Palmitic acid |
not more intense than the principal spot obtained with reference solution |
Conforms | |
| water | no more than 2% | 0.56% | |
| Related Substances | phosphatidylinositol: no more than 1% | 0.42% | |
| LPE: no more than 0.5% | 0.4% | ||
| Sphingomyelin: no more than 3% | 1.8% | ||
| LPC: no more than 3% | 1.8% | ||
| Total impurity: 8.0% | 4.4% | ||
| Residual solvent |
ethanol: no more than 0.2%; acetone: no more than 0.2% petroleum ether: no more than 0.05% total residue solvent: no more than 0.5% |
0.03% 0.001% ND 0.03% |
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| Triglycerides | no more than 3.0% | Conforms | |
| Cholesterol | no more than 1.0% | Conforms | |
| Palmitic Acid | no more than 0.2% | Conforms | |
| Protein | should meet the requirements | Conforms | |
| Arsenic Salt | no more than 0.0002% | Conforms | |
| Microbial Limit | Total aerobe:no more than 100cfu/g Mycete&Saccharomycetes:no more than 100cfu/g Escherichia coli,salmonella,pseudomonas aeruginosa and staphylococcus aureus can not be detected. |
Conforms | |
| Bacterial Endotoxins | no more than 2.0EU/g | Conforms | |
| Heavy Metals | no more than 5 per million | Conforms | |
| Assay | P:3.5-4.1% | 3.8% | |
| N:1.75-1.95% | 1.89% | ||
| LPC:72-85% | 83.9% | ||
| LPE:5-10% | 9.5% | ||
| The sum of LPC and LPE: no less than 80% | 93.4% | ||
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| Xi'an Libang Pharmaceutical Co., Ltd. |
| 17/F, Block E, Wangzuo International Plaza, No.1, Tangyan Road, Xi’an Hi-tech Zone, Shaanxi, P.R.China 710075 |
| 86-29-89527363 |
| jiangping@libang.com.cn |