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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)
