Bacterial Endotoxin Test for Excipients Sorbitol for Injection Preparations

OBJECTIVE To establish a bacterial endotoxin method for excipients sorbitol for injection preparations. METHODS According to the method in the appendix of the Chinese Pharmacopoeia(2010), the bacterial endotoxin test was carried out. RESULTS The preparation did not interfere with endotoxin test below the concentration of 0.2 g·mL^-1. CONCLUSION The method of bacterial endotoxin test is feasible with the limit of 2.5 EU·g^-1 for excipients sorbitol for injection preparations.