Comparison Of Content Uniformity Of Inspection Methods In China, The United States And Japan

Content uniformity test is an analytic method to assess the consistence for the lot products with evaluating the content uniformity degree of the small amount drug samples which are collected randomly. After comparing and assessing ChP 1990, USP XXVIII and JP XIV, this article has promoted a new content uniformity test program for ChP 2010.1. According to the drug standards, the content uniformities of 120 dexamethasone acetate, chlorphenaminemaleate and isosorbide dinitrate tablets on market are tested respectively. With thestatistic analysis and x~2 statistical hypothesis of the test result, the results of content for the tablets are normal distribution.2. The methods of ChP 1990, USP XXVIII and JP XIV are compared with means of computer simulation. With the method of ChP 1990, the lot tolerance percent defective, retest possibility, average sample number and disputable zone is 9.4%, 27.4%, 15.5 and 15.0%, respectively. With the method of USP XXVIII, the lot tolerance percent defective, retest possibility, average sample number and disputable zone is 5.5%, 69.6%, 23.9 and 11.1%, respectively. With the method of JP XIV, the lot tolerance percent defective, retest possibility, average sample number and disputable zone is 4.0%, 71.1%, 24.4 and 9.6%, respectively.3. On the base of USP XXVIII method, the determination of non-conformity acceptability constant k for the first sample and the necessity of number characteristic deletion are discussed. With the improvement of USP XXVIII method, the new method is promoted.4. With the new method, the lot tolerance percent defective, retest possibility, average sample number and disputable zone is 5.5%, 22.9%, 14.6 and 11.1%, respectively.