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理化指标 Physical and chemical indicators |
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PC-80 |
PC-90 |
PC-95 |
PC-98 |
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性状 Appearance |
黄色蜡状 Yellow waxy |
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磷 P |
≥2.7% |
≥2.7% |
≥2.7% |
≥2.7% |
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氮 N |
1.5～2.0% |
1.5～2.0% |
1.5～2.0% |
1.5～2.0% |
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磷脂酰胆碱 PC |
≥80% |
≥90% |
≥95% |
≥98% |
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磷脂酰乙醇胺 PE |
≤30% |
≤30% |
≤30% |
≤30% |
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磷脂酰胆碱和磷脂酰乙醇胺 PC+PE |
≥80% |
≥90% |
≥95% |
≥98% |
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丙酮不溶物 Acetone insolubles |
≥90% |
≥90% |
≥90% |
≥90% |
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溶血磷脂酰乙醇胺 LPE |
≤1% |
≤1% |
≤1% |
≤1% |
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溶血磷脂酰胆碱 LPC |
≤3.5% |
≤3.5% |
≤3.5% |
≤3.5% |
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溶血磷脂酰乙醇胺和溶血磷脂 酰胆碱 LPE+LPC |
≤4.0% |
≤4.0% |
≤4.0% |
≤4.0% |
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磷脂酰肌醇 PI |
≤5.0% |
≤5.0% |
≤5.0% |
≤5.0% |
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总有关物质 Total related substances |
≤8.0% |
≤8.0% |
≤8.0% |
≤8.0% |
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己烷不溶物Hexane insolubles |
≤0.3% |
≤0.3% |
≤0.3% |
≤0.3% |
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水分 Moisture |
≤1.5% |
≤1.5% |
≤1.5% |
≤1.5% |
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总残留溶 剂 |
Total residual solvents |
≤0.5% |
≤0.5% |
≤0.5% |
≤0.5% |
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蛋白质 Protein |
不得检出 |
不得检出 |
不得检出 |
不得检出 |
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酸 值 |
Acid value |
≤30 |
≤30 |
≤30 |
≤30 |
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碘值 Lodine value |
≥75 |
≥75 |
≥75 |
≥75 |
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过氧化 值 |
Peroxide value |
≤3.0 |
≤3.0 |
≤3.0 |
≤3.0 |
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微生物、细菌内毒素Microorganismss, bacterial endotoxins |
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PC-80 |
PC-90 |
PC-95 |
PC-98 |
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霉菌和酵母菌总数 TYMC |
≤100cfu/g |
≤100cfu/g |
≤100cfu/g |
≤100cfu/g |
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大肠埃细菌 E. coli |
每1g不得检 出 ND/ 1g |
每 1g 不得检 出 not ND/ 1g |
每 1g不得检 出 not ND/ 1g |
每 1g 不得检 出 not ND/ 1g |
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沙门菌 Salmonella |
每 10g 不得检 出 not detectable/ 10g |
每 10g 不得检 出 not detectable/ 10g |
每 10g不得检 出 not detectable/ 10g |
每 10g 不得检 出 not detectable/ 10g |
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细菌内毒素 Endotoxins
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＜2.0Eu/g |
＜2.0Eu/g |
＜2.0Eu/g |
＜2.0Eu/g |
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重金属heavy metals |
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PC-80 |
PC-90 |
PC-95 |
PC-98 |
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重金属 |
Heavy metals |
≤5ppm |
≤5ppm |
≤5ppm |
≤5ppm |
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砷 Arsenic |
≤2ppm |
≤2ppm |
≤2ppm |
≤2ppm |
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铅 Lead |
≤2ppm |
≤2ppm |
≤2ppm |
≤2ppm |
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医药制品 Medical products |
Injection emulsion, the material of Liposome medicine and the carbon fluoride emulsions. |
Packages:
Net weight: 10 Kg/box, divided into 1Kg × 10bags and 5Kgs × 2bags;
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 Months Sealed, avoiding light, store at low temperature(below1 - 18℃);
Standard of execution:
Chinese Pharmacopoeia 2015 Standard for Soya lecithin(for injection)
