Abstract:
OBJECTIVE To explore the feasibility of the E.coil count plate to replace the pharmacopoeia method in E.coil test of Piracetam tablets. METHODS According to the alternative method validation guiding principle, the validation of qualitative test parameters were tested and compared with the pharmacopoeia method. RESULTS No statistically substantial difference in test result was found between E.coil count plate and the pharmacopoeia method (
P>0.05). CONCLUSION Results prove that the E.coil count plate is accurate and easy-to-use to the alternative method of piracetam tablets E.coil test.