Determination uncertainty of aluminum residues in human albumin using top-down evaluation

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.

Keywords

• top-down
• icp-ms
• uncertainty
• human albumin
• aluminum