Product Advantages
The injection grade phosphatidylcholine supplier ensures all batches conform to pharmaceutical soy lecithin manufacture standards, supporting consistent purity and phosphatidylcholine content critical for injectable formulations. The design incorporates soy lecithin-derived phospholipids optimized for liposome raw material functionality, enhancing system compatibility. This structural approach facilitates modular integration into existing injection preparations and supports scalable manufacturing processes, providing comprehensive control over quality parameters required in regulatory environments.
This solution delivers superior bioavailability and rapid systemic absorption due to its injection-grade phosphatidylcholine formulation, enhancing therapeutic efficacy. Its pharmaceutical soy lecithin manufacture origin guarantees high safety and minimal immunogenicity, optimizing patient outcomes. Moreover, it supports ease of formulation for developers by providing a stable phosphatidylcholine concentrate suitable for liposome raw material incorporation, streamlining workflow and reducing formulation variability in clinical and pharmaceutical settings.
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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)
