Abstract:
OBJECTIVE To determine the content of 5-hydroxymethyl furfural and furfural, which are the genotoxic degradation products of dextran 40 glucose injection, and to analyze the risk factors.
METHODS HPLC was used to determine the content of 5-hydroxymethyl furfural and furfural in dextran 40 glucose injection, and raw materials of dextran 40 and glucose. The effects of raw materials, process parameters(temperature, pH value), and storage time on the contents of degradation products were investigated.
RESULTS The content of 5-hydroxymethyl furfural and furfural was linear in the range of 0.12-12.43 μg·mL
-1 and 0.03-8.60 μg·mL
-1. The content of degradation impurities in dextran 40 glucose injection was affected by process parameters(temperature, pH value) and storage time, raw materials didn't affect its content.
CONCLUSION It is necessary to pay more attention to the key process parameters related to heating dissolution and adjusting pH value in the production process, so as to improve the stability of the dextran 40 glucose injection. At the same time, attention should be paid to the increase of related impurities caused by excessive storage time.