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Determination of migration of 7 elements in recombinant human coagulation factor Ⅷ-Fc fusion protein for injection by ICP-MS
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Hao DING
Chinese Journal of Pharmaceutical Analysis | 2024, 44(8) : 1437 - 1442
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(8): 1437-1442
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Determination of migration of 7 elements in recombinant human coagulation factor Ⅷ-Fc fusion protein for injection by ICP-MS
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Hao DING
Affiliations
  • Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China
Published: 2024-08-31 doi: 10.16155/j.0254-1793.2023-0531
Outline
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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 factor Ⅷ-Fc fusion protein for injection  /  elemental impurity  /  package compatibility  /  migrating migration
Hao DING. Determination of migration of 7 elements in recombinant human coagulation factor Ⅷ-Fc fusion protein for injection by ICP-MS[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (8) : 1437 -1442 . DOI: 10.16155/j.0254-1793.2023-0531
Year 2024 volume 44 Issue 8
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doi: 10.16155/j.0254-1793.2023-0531
  • Receive Date:2023-08-17
  • Online Date:2026-03-13
  • Published:2024-08-31
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  • Received:2023-08-17
Affiliations
    Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China
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表12种不同金属材料的力学参数

Family
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Number of
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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
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