蛋黄卵磷脂（EPC)
蛋黄卵磷脂是以蛋黄粉末磷脂为原料，经乙醇萃取等工序，采用独创的专利设备（ZL20...
蛋黄卵磷脂（供注射用）是以蛋黄粉末磷脂为原料，经乙醇萃取等工序，采用独创的专利设备（ZL2017.2 0049599.7；ZL2010.2 0147413.X）精制、纯化而成的黄色或淡黄色蜡状产品。由于较强的抗氧化能力及其独特的表面活性能力和生理学特性，被广泛应用于医药、营养学领域及化妆品行业。
产品规格：Product Specifications
理化指标Physical and chemical indicators | ||
EPC-80 | EPC-98 | |
性状 Appearance | 本品为淡黄色粉末或蜡状固体light yellow powder or waxy solid | |
磷 P | 3.5～4.1% | 3.5～4.1% |
氮 N | 1.75～1.95% | 1.75～1.95% |
磷脂酰胆碱 PC | ≥80% | ≥98% |
磷脂酰乙醇胺 PE | ≤20% | ≤20% |
磷脂酰胆碱和磷脂酰乙醇胺PC+PE | ≥80% | ≥98% |
磷脂酰肌醇 PI | ≤5.0% | ≤5.0% |
溶血磷脂酰胆碱 LPC | ≤3.5% | ≤3.5% |
溶血磷脂酰乙醇胺 LPE | ≤1% | ≤1% |
溶血磷脂酰胆碱和溶血磷脂酰乙醇胺 LPC+LPE | ≤4.0% | ≤4.0% |
鞘磷脂 Sphingolipids | ≤3.0% | ≤3.0% |
总有关物质 Total related substances | ≤8.0% | ≤8.0% |
皂化值 Saponification value | 195～212 | 195～212 |
酸值 Acid value | ≤20.0 | ≤20.0 |
碘值Iodine value | 60～73 | 60～73 |
过氧化值 Peroxide value | ≤3.0 | ≤3.0 |
游离脂肪酸 Free fatty acids | ≤1% | ≤1% |
甘油三酸脂 Triglyceride | ≤3% | ≤3% |
胆固醇 cholesterol | ≤2% | ≤2% |
棕榈酸 Palmitic acid | ≤0.2% | ≤0.2% |
总残留溶剂 Total residual solvents | ≤0.5% | ≤0.5% |
水分 Moisture | ≤3% | ≤3% |
蛋白质 Protein | 不得检出 | 不得检出 |
微生物、细菌内毒素Microorganismss, bacterial endotoxins | ||
EPC-80 | EPC-98 | |
细菌内毒素 Bacterial endotoxin | ＜2.0Eu/g | ＜2.0Eu/g |
需氧菌总数TAMC | ≤100cfu/g | ≤100cfu/g |
霉菌和酵母菌总数 TYMC | ≤100cfu/g | ≤100cfu/g |
大肠埃希菌 E.coli | 每1g不得检出 Not detectable/1g | 每1g不得检出 Not detectable/1g |
沙门菌 Salmonella | 每10g不得检not detectable/10g | 每10g不得检出not detectable/10g |
重金属Heavy metals | ||
EPC-80 | EPC-98 | |
重金属 Heavy metals | ≤5ppm | ≤5ppm |
砷盐 Arsenic | ≤2ppm | ≤2ppm |
其他规格蛋黄卵磷脂（供注射用）可根据客户要求提供。Other specifications of Egg yolk Lecithin(for injection) will be available upon requestt.
应用范围：Scope of application
医药制品Medical products | 注射用乳剂的乳化剂 emulsifier for injection |
包装规格：Packing Specifications
净重：10Kg/箱，分1Kg×10袋及2.5Kg×2袋两种规格；
Net weight: 10 Kg/box, divided into 1 Kg × 10 bags and 2.5 Kg × 2 bags;
内包装采用双层包装：内层为药用低密度聚乙烯袋，外层为铝箔袋；
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;
外包装采用双层包装：内层为泡沫箱内置冰盒，外层为纸箱；
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;
外包装尺寸：610x460x315mm
Packing size: 610 X 460 X 315mm
储存条件及保质期:Storage conditions and shelf life
密封，避光，低温（-18℃以下）保存；保质期24个月
Sealed, avoiding light, store at low temperatures(below -18℃); Shelf life :12 months.
执行标准standard of execution
《中国药典》2020年版蛋黄卵磷脂（供注射用）标准
Chinese Pharmacopoeia 2020 Standard for Egg Yolk lecithin(for injection)
