Preparation of the First Chinese National Standard for Human Albumin
WANG Min-li, XIAO Lin, ZHOU Qian, YANG Peng-yun, LI Man, GUAN Li-dong, HAO Jie, WANG Qing-zhou, HOU Ji-feng*
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Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 100050, China
OBJECTIVE To prepare the first batch of Chinese national standard for human albumin used for the test of batch release or other quality control of human albumin products.METHODS The first batch of national standard for human albumin was prepared with certificated human albumin products, mixed and filled under aseptic conditions. The standards were distributed to 11 laboratories for cooperative calibration according to the unified methods published on China Pharmacopeia.Seven test items including total protein content, sodium caprylate, polymers content, pH,absorbance,sodium content, and aluminium content were detected. RESULTS The limits of the six test items except aluminium content were established as follows after the data from 11 collaboration laboratories were received and statistically analyzed: total protein(193.30±5.08)g·L-1;sodium caprylate (0.162 4±0.009 2) mmol·g(Pro)-1; polymers content (2.72±0.29)%( HPLC-SEC);pH(6.71±0.08)[temperature (22±3)℃];absorbance 0.030±0.005;sodium content (134.9±23.6)mmol ·L-1.The range of initially established aluminium content was (88.4±30.5)μg·L-1. However,it was observed to increase obviously after 21 months according to the trend analysis, so it was deleted from the test items for the national standard for human albumin ultimately.CONCLUSION The prepared national standard for human albumin met the relevant requirements and may be served as the first generation of national standard for human albumin products.
WANG Min-li, XIAO Lin, ZHOU Qian, YANG Peng-yun, LI Man, GUAN Li-dong, HAO Jie, WANG Qing-zhou, HOU Ji-feng.
Preparation of the First Chinese National Standard for Human Albumin[J]. Chinese Pharmaceutical Journal, 2017, 52(6): 480-487 https://doi.org/10.11669/cpj.2017.06.012
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