中国药典三部血液制品方法包20120323

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1、中国药典三部血液制品方法包SepaxTechnologies"BetterSurfaceChemistryforBetterSeparation."www.sepax-tech.com中国药典三部附录部分：¾ⅥQ人血白蛋白多聚体测定法SEC¾ⅥR人免疫球蛋白类制品IgG单体及二聚体测定法SEC¾ⅥP人血液制品中糖及糖醇测定法Carbomix-H¾ⅦH枸橼酸离子测定法Carbomix-HSepaxTechnologies"BetterSurfaceChemistryforBetterSeparation

2、."www.sepax-tech.comⅥQ人血白蛋白多聚体测定法SEC•检定项目中：多聚体含量的检测（附录ⅥQ）•附录ⅥQ：人血白蛋白多聚体测定法•要求：应不高于5.0%•色谱条件与系统适用性试验：色谱柱：用亲水硅胶高效体积排阻柱(SEC,排阻极限300kD，粒度10um)，柱直径7.5mm，长60cm；流动相：含1%异丙醇的pH7.0、0.2mol/L磷酸盐缓冲液检测波长：280nm流速：0.6mL/min样品浓度：12mg/mL进样量:20uL要求：人血白蛋白单体峰和二聚体峰间的分离度应大于1.

3、5，拖尾因子按人血白蛋白单体峰计算应为0.95～1.40。SepaxTechnologies"BetterSurfaceChemistryforBetterSeparation."www.sepax-tech.com人血白蛋白Column:SRT-300(5µm,300Å,7.8x600mm)SRT-300(5µm,300Å,7.8x50mm)Mobilephase:0.2MPhosphatebuffer(pH7.0,1%Isopropylalcohol)Flowrate:0.6mL/minDetec

4、tor:UV280nmColumntemperature:RoomtemperatureInjectionvolume:20µLmAUSRT-300-7860-34012-人血白蛋白-1236mAU局部放大图50032.09755.46280400604030019.8862029.09920000102030405060min10000102030405060minHumanSerumAlbuminSepaxTechnologies"BetterSurfaceChemistryforBetterSe

5、paration."www.sepax-tech.comSRT-300对人血白蛋白多聚体的检测实验条件：Column:SRT-300GuardColumn:SRT-300Mobilephase:0.2MPhosphatebuffer(pH7.0,1%Isopropylalcohol)Flowrate:0.6mL/minDetector:UV280nmColumntemperature:25℃Injectionvolume:20µLSample:1/4.17HumanImmunoglobulinsolu

6、tioninmobilephase(12mg/mL)连续进样150针，每隔15针叠加数据InjectionRTPlatesTailingResolution132.16184881.142.491532.14179321.102.473132.13178611.162.464532.17183891.182.516132.15175711.192.497532.18164781.182.459132.18173511.202.4810532.17161961.202.4313132.13179641.

7、382.5215032.12180051.372.61SepaxTechnologies"BetterSurfaceChemistryforBetterSeparation."www.sepax-tech.comSRT-300-34012-人血白蛋白-150mAUSRT-300-34012-人血白蛋白-131300SRT-300-34012-人血白蛋白-105250SRT-300-34012-人血白蛋白-91SRT-300-34012-人血白蛋白-75200SRT-300-34012-人血白蛋白-61

8、150SRT-300-34012-人血白蛋白-45100SRT-300-34012-人血白蛋白-31SRT-300-34012-人血白蛋白-1550SRT-300-34012-人血白蛋白-10SepaxTechnologies0102030405060min"BetterSurfaceChemistryforBetterSeparation."www.sepax-tech.comⅥR人免疫球蛋白类制品IgG单体及二聚体测定法SEC•检定项目中：分子大小分