A comparison of the technical quality of American and Japanese ranitidine tablets

Abstract

The purpose of this study was to compare the technical quality of commercial American and Japanese ranitidine tablets. Five brands of 150-mg USP tablets and six brands of 150-mg JP tablets were compared on hardness, friability, average weight, average content, content uniformity, and dissolution. The difference in hardness between American and Japanese tablets was significant. Dissolution profiles of Japanese tablets were not significantly different from one other, whereas those of American tablets were significantly different. However, all brands complied with USP 27. Since all brands can be expected to be in therapeutic use, this result supports the use of the USP criterion as an indicator for therapeutic efficacy.