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理化指标Physical and chemical indicators |
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PC-50 |
PC-70 |
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性状 Appearance |
黄色蜡状 Yellow waxy |
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磷 P |
≥2.7% |
≥2.7% |
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氮 N |
1.5～2.0% |
1.5～2.0% |
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磷脂酰胆碱 PC |
≥45.0% |
≥70.0% |
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磷脂酰乙醇胺 PE |
≤30.0% |
≤30.0% |
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磷脂酰胆碱和磷脂酰乙醇胺 PC+PE |
≥70% |
≥70% |
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丙酮不溶物 |
Acetone insolubles |
≥90.0% |
≥90.0% |
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己烷不溶物 |
Hexane insolubles |
≤0.3% |
≤0.3% |
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水分 Moisture |
≤1.5% |
≤1.5% |
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总残留溶剂 |
Tota residualsolvents |
≤0.5% |
≤0.5% |
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酸值 |
Acid value |
≤30 | ≤30 |
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碘值 |
Iodine value |
≥75 |
≥75 |
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过氧化值 |
Peroxide value |
≤3.0 |
≤3.0 |
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微生物 Microorganisms |
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PC-50 |
PC-70 |
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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Negative/ 1g |
每 1g不得检出 |
Negative/ 1g |
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沙门菌 Salmonella |
每 10g不得检出 |
Negative/ 10g |
每 10g不得检出 |
Negative/ 10g |
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重金属 heavy metals |
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PC-50 |
PC-70 |
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重金 属 |
≤20ppm |
≤20ppm |
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砷 Arsenic |
≤2ppm |
≤2ppm |
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铅 Lead |
≤2ppm |
≤2ppm |
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医药制品 Medical products |
广泛用作口服制剂的乳化剂、增溶剂、分散剂，以及口服药物的生物利用度增强剂和局部渗透增强剂。 Widely used as emulsifiers, Isolub ilizers, dispersants ,and bioavailability enhancers and local penetration enhancers for oralI rugs. |
Packages:
Net weight: 10Kgs/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;
Packing size: 610 X 460 X 315mm.
Storage conditions and shelf life:
12-18 Months Sealed, avoiding light, store at low temperature(below - 18℃).
Standard of Execution:
Chinese Pharmacopoeia 2015 Standard for Soya lecithin.
