Comparison Study of the Content Uniformity Tests in Chinese Pharmacopoeia and United States Pharmacopeia Based on Monte Carlo Simulation

OBJECTIVE To study the performance of the content uniformity(CU) tests in the Chinese Pharmacopoeia(ChP) and the United States Pharmacopeia(USP) and provide ideas to improve the performance of the tests. METHODS Monte Carlo method was applied to simulate the drug product quality as well as the sampling process. The accuracies of CU tests in ChP and USP were compared as the performance index; the effects of parameters on the accuracies were studied through the central composite design(CCD) experiments. RESULTS There was no significant difference between the accuracies of CU tests in ChP and USP; the results of CCD experiments showed that parameters of the CU tests in both ChP and USP could be further optimized to improve accuracies. CONCLUSION The accuracies of CU tests in ChP and USP is basically the same and new ideas to optimize the parameters of CU tests are provided.