To establish an inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of migration Co,As,Br,Cd,Sb,Ba and Pb in recombinant human coagulation factor Ⅷ-Fc fusion protein for injection,and to quantitatively analyze the compatibility of long-term stored samples.
After adding 0.75 mL of water to the sample for 4 h,the purified water was filled to 5 mL,and the contents of 7 elements in the solution were determined by standard addition method. The working parameters of ICP-MS:radio frequency (RF) power of 1 550 W,sampling depth of 10.0 mm,carrier gas flow rate of 0.50 L·min-1,atomizer pump speed of 0.30 r·s-1,atomization chamber temperature of 2 ℃,dilution gas flow rate of 0.74 L·min-1,repeated sampling times of 3 times,analysis mode of full quantitative.
The linear relationship of each element was good in the concentration range of the detected mass,and the recoveries of the element added were 92.0%-101.8%. When applied to the determination of the samples at each accelerated placement point,the increased migration amounts were 43.2,68.7 and 66.8 ng·mL-1,respectively,except the element content of Br increased slightly. The contents of the remaining 6 elements were far below the prescribed limit.
The method is reliable and can be used for the determination of migration of 7 elements in recombinant human coagulation factor Ⅷ-Fc fusion protein for injection.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |