薬発第297号に基づく内用液剤及びX線造影剤の微生物汚染度の実態調査

概要

論文の詳細を見る
The microbial quality control of 41 solutions or suspensions for internal use and of 8 radiopaque media was investigated by the test method described in PAB Notification No. 297 (valid on April 1, 1976). All of the 49 pharmaceutical products tested met the standard requirements provided in the Notification, so that they are considered to be under good microbial quality control. Most of the sample solutions of radiopaque media were turbid and were difficult to be put to the test for microbial count. In this point, the test method for the microbial count is desired to be improved. A test method of estimating the possible antimicrobial activity of products is also desired to be standardized, because the antimicrobial activity may affect the final results of the tests in the Notification.
日本医療薬学会の論文
1978-02-20