ABSTRACT
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.
ABSTRACT
A method was developed for the determination of sodium caprylate in human serum albumin by reversed phase high performance liquid chromatography(RP-HPLC) after pre-column derivatization. The caprylic acid, extracted from human serum albumin by hexane, was treated with ω-bromoacetophenone and 18-crown-6 for 30 min at 50 ℃, and analyzed on a Nova-Park C_(18)(150 mm×3.9 mm, 4 μm) column with methanol-water(75∶ 25, V/V) as the mobile phase. The internal standard was enanthic acid, the flow rate was 1.0 mL/min and the detection wavelength was 262 nm. The extraction yield of caprylic acid was 97.9% and that of enanthic acid was 98.2%. The linear range of sodium caprylate was 9.00×10~(-4)-1.44×10~(-2) mol/L(r=0.9995). The average recovery of caprylic acid was 99.7%, RSD was less than 0.9%. The present method is reliable and relatively simple and can be used for the determination of sodium caprylate in human serum albumin.