Pharmaceutical Excipients Egg Lecithin GMP Purified Egg Phospholipids
Contact Person : Jimmy Tian
Phone Number : 86-18602905046
WhatsApp : +8618602905046
Detail Information |
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Quality Specification: | USP EP JP CP | Pack: | 4kg In A Bag |
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Storage: | Store At Below ~15℃ | PC: | 72.0~85.0% (E80) |
Colour: | Slight Yellow White | Appearance: | Powder |
High Light: | GMP Egg Lecithin Powder,Egg Lecithin Powder USP,EP Egg Yolk Phosphatidylcholine powder |
Product Description
Egg Lecithin injectable grade USP EP CP
Xi'an Libang Pharmaceutical Co..Ltd developed Egg Lecithin with superior quality in China and 3 APIs Plants Located in Xi’an, Baoji and Shenyang those all Fully in compliance with the cGMP Inspected and approved by US FDA Dedicated for high-valued APIs commercialization. COA is copied as bellow:
Items | Specifications | Results | |
Appearance | Almost white or yellow solid. | Conforms | |
Identification: TLC | The RF values of the spots from the sample solution correspond to those from Standard solutions | Conforms | |
Tests | |||
Water | No more than 6.0% | 1.5% | |
Acetone-insoluble matter | NLT 90.0% | 98% | |
Acid value | NMT 20.0 | 8 | |
Peroxide Value | NMT 3 | 0.4 | |
Impurities | Lead | NMT 10ppm | Conforms |
Hexane-insoluble matter | NMT 0.3% | 0.12% | |
Nonphosphatidyl lipids | NMT 7.0% | 1.9% | |
Residual solvents | Ethanol: NMT 0.2%; | 0.01% | |
Acetone: NMT 0.2% | Not detected | ||
Diethyl ether: NMT 0.2%; Petroleum ether: NMT 0.05% |
Not detected Not detected |
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n-hexane: NMT 0.02%; | Not detected | ||
Total residue solvent: NMT 0.5% | 0.01% | ||
Microbial Limit |
Total microbial count: NMT100cfu/g Escherichia coli andsalmonella: Absence |
Conforms | |
Bacterial Endotoxins | NMT 6.0EU/g | Conforms | |
Assay |
Phosphatidylcholine:80.0%~85.0% | 83.3% | |
Phosphatidylethanolamine:7.0%~9.5% | 8.4% | ||
Lysophosphatidylcholine: NMT3.0% | 1.9% |
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