Product Advantages
The bulk egg yolk lecithin manufacturer leverages advanced extraction technology to enhance phosphatidylcholine purity and maintain biochemical stability, resulting in a structurally superior pharmaceutical phospholipid. Its molecular composition is optimized for injection-grade applications, ensuring compatibility with sterile parenteral delivery systems and reducing aggregation risk. The product’s design supports modular use in diverse formulation platforms, enabling seamless integration with intravenous delivery mechanisms and pharmaceutical excipients. Such system-level compatibility enables pharmaceutical developers to streamline production processes and uphold stringent quality standards, addressing complex clinical requirements efficiently with a precisely engineered egg yolk lecithin substrate.
Utilizing high-purity phosphatidylcholine, this pharmaceutical phospholipid delivers consistent bioavailability and metabolic support critical to therapeutic efficacy. Its easy emulsification and stability in injectable solutions improve handling and assure dosage accuracy within clinical environments. Users benefit from reliable batch-to-batch consistency and compliance with pharmaceutical regulations, contributing to predictable pharmacokinetics and enhanced patient safety. The product’s proven ability to support brain and liver membrane repair elevates its performance profile, making it an indispensable component in formulations addressing neurological and metabolic conditions. This ease of integration and clinical utility maximizes the value delivered to healthcare professionals and pharmaceutical manufacturers.
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理化指标Physical and chemical indicators |
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EPC-80 |
EPC-98 |
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性状 Appearance |
本品为淡黄色粉末或蜡状固体light yellow powder or waxy solid |
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磷 P |
1.75～1.95% |
1.75～1.95% |
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氮 N |
3.5～4.1% |
3.5～4.1% |
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磷脂酰胆碱 PC |
≥80% |
≥98% |
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磷脂酰乙醇胺 PE |
≤20% |
≤20% |
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磷脂酰胆碱和磷脂酰乙醇胺 PC+PE |
≥80% |
≥98% |
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磷脂酰肌醇 PI |
≤5.0% |
≤5.0% |
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溶血磷脂酰胆碱 LPC |
≤3.5% |
≤3.5% |
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溶血磷脂酰乙醇胺 LPE |
≤1% |
≤1% |
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溶血磷脂酰胆碱和溶血磷脂酰 乙醇胺 LPC+LPE |
≤4.0% |
≤4.0% |
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鞘磷脂 Sphingolipids |
≤3.0% |
≤3.0% |
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总有关物质 Total related substances |
≤8.0% |
≤8.0% |
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皂化值 Saponification value |
195～212 |
195～212 |
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酸值 Acid value |
≤20.0 |
≤20.0 |
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碘 值 |
Iodine value |
60～73 |
60～73 |
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过氧化值Peroxide value |
≤3.0 |
≤3.0 |
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游离脂肪酸 Free fatty acids |
≤1% |
≤1% |
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甘油三酸脂 Triglyceride |
≤3% |
≤3% |
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胆固醇 cholesterol |
≤2% |
≤2% |
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棕榈酸 Palmitic acid |
≤0.2% |
≤0.2% |
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总残留溶剂 Tota residual solvents |
≤0.5% |
≤0.5% |
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水分 Moisture |
≤3% |
≤3% |
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蛋白质 Protein |
ND |
ND |
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微生物、细菌内毒素Microorganismss, bacterial endotoxins |
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EPC-80 |
EPC-98 |
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细菌内毒素 Bacterial endotoxin |
＜2.0Eu/g |
＜2.0Eu/g |
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需氧菌总数 TAMC |
≤100cfu/g |
≤100cfu/g |
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霉菌和酵母菌总数 TYMC |
≤100cfu/g |
≤100cfu/g |
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大肠埃细菌 E.coli |
每 1g不得检出 |
每 1g不得检出 Not detectable/1g |
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沙门菌 Salmonella |
每 10g不得检not detectable/10g |
每10g不得检出not detectable/ 10g |
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重金属Heavy metals |
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EPC-80 |
EPC-98 |
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重金属 |
≤5ppm |
≤5ppm |
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砷盐 Arsenic |
≤2ppm |
≤2ppm |
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医药制品 |
Medical products |
注射用乳剂的乳化剂 emulsifier for injection |
Packages:
Net weight: 10 Kg/box, divided into 1 Kg × 10 bags and 5 Kg × 2 bags;
The inner packaging adopts double-layer packaging: the inner layer is a medicinal low-density polyethylene bag, and the outer layer is an aluminum foil bag;
The outer packaging adopts double-layer packaging: the inner layer is a foam box with a built-in ice box and the outer layer is a carton;
Outside Packing size: 610 X 460 X 315mm
Storage conditions and shelf life:
12-18 Months, Sealed, avoiding light, stored at low temperatures(below1- 18℃);
Standard of execution:
Chinese Pharmacopoeia 2015 Standard for Egg Yolk lecithin(for injection)
