Abstract: Objective To establish the safety test methods for ornithine aspartate injection. Methods Abnormal toxicity test, allergic response test, and depressor substances test were added and their limit values were set separately on the basis of pyrogen test in present national standard. The correlative verification tests were carried out according to the methods indexed in the appendix of Ch.P 2010 Vol II. Results The limit value of abnormal toxicity test was 0.87g?kg-1, the limit value of allergic response test was 0.83g?kg-1 and the limit value of depressor substances test was 0.15g?kg-1. Conclusion This study provided experimental basis for the improved quality standard of ornithine aspartate injection.