Study on the Practicability of Bacterial Endotoxins Test for Adenosine Disodium Triphosphate Raw Material / 中国药房

ABSTRACT

OBJECTIVE: To establish bacterial endotoxin test for adenosine disodium triphosphate (ATP) raw material by TAL method. METHODS: The sensitivity of TAL and the limit of endotoxin were reviewed and confirmed. Preliminary interference test was used to determine the dilution ratio of samples and interference test was applied to determine maximum non-interference concentration. Bacterial endotoxin test was performed on 11 batches of samples according to the method stated in Chinese Pharmacopoeia (2005 edition). RESULTS: The sensitivity of TAL was up to the standard and the limit of endotoxin in samples were 2.0 EU?mg-1. The maximum non-interference concentration was 0.125 mg?mL-1. Results of bacterial endotoxins test of 11 batches of samples were all in line with the standard. CONCLUSIONS: It is feasible to detect the bacterial endotoxin of ATP raw material by TAL methods, which can replace pyrogen test.