This Guidelines is formulated for clinic safety and quality control of injections in chemical medicines and traditional Chinese medicines.

The Guidelines includes tests for abnormal toxicity, bacterial endotoxins (or pyrogens), depressor substances (including histamine), allergen, haemolysis, and agglomeration, etc. Testing projects and suitability studies should be established according to ingredients, procedures, usages, and dosage. Depending on the results of suitability study, bacterial endotoxins, and pyrogens are interchangeable testing items and only one of them should be selected. So are depressor substances and histamine testing items.