[Exceptional Application of Content Uniformity Test and Weight Variation Test in the Japanese Pharmacopoeia 13 revision and usage of these tests for in-process tests].
The criteria of Content Uniformity test and Weight Variation test in JP 13 were greatly changed to reduce consumer's risk. The new criteria were set to keep the rate of defectives in lots passing the tests less than the acceptable rate. However, in some cases, the new criteria can not directly be applied to some formulations and several modifications are needed in the criteria. In this report, the several resolution of this problem are represented. The applicability of these tests for in-process tests is also discussed.
Katori
N
N
katori@nins.go.jp
Aoyagi
N
N
Kojima
S
S
D007564:Japan; D010602:Pharmacopoeias as Topic / Q000592:standards*; D014894:Weights and Measures