The Current Situation of Japanese Medicinal Plants Industry and its Significance on the Pharmaceutical Industry 3-3-3 - 農業知識入口網

3-3-3. Microorganisms

The JP identifies acceptable limits for the following microorganisms in drugs as general information (and not as mandatory regulation): aerobic bacteria, molds and yeasts, enterobacteria and other gram-negative bacteria, Escherichia coli, Salmonella, Staphylococcus aureus. Category 1 lists established limits for crude drugs for extract formulations and decoctions which are manufactured at high temperature. Category 2 represents the more rigidly, regulating limits for powdered crude drugs, pills or powders which are manufactured without heat.