Determination uncertainty of aluminum residues in human albumin using top-down evaluation / 中国输血杂志

ABSTRACT

【Objective】 To evaluate the determination uncertainty of aluminum residues in human albumin by inductively coupled plasma mass spectrometry (ICP-MS). 【Methods】 The aluminum residues in human albumin was determined by ICP-MS, and the top-down method was applied to assess the reasons of uncertainty and calculate the uncertainty. 【Results】 The relative standard uncertainty of the aluminum content in human albumin at the three quality control levels was 0.54 ng/mL, 1.68 ng/mL and 4.54 ng/mL, respectively, which met the requirements of the guidelines for bioanalytical methods in the Chinese Pharmacopoeia(2020). 【Conclusion】 The top-down method is simple and quick to assess the uncertainty of aluminum residues in human albumin, and is suitable for the uncertainty assessment of analytical methods in biological laboratories.