Determination of migration of 7 elements in recombinant human coagulation factor Ⅷ-Fc fusion protein for injection by ICP-MS
Objective: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.Methods: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.Results: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.Conclusion: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.
inductively coupled plasma mass spectrometry(ICP-MS)recombinant human coagulation factorⅧ-Fc fusion protein for injectionelemental impuritypackage compatibilitymigrating migration
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