Popis: |
A standardized method of testing the efficacy of preservatives in pharmaceutical products is presented. The test consists of the addition of a predetermined number of microorganisms of different species to the product, incubation of the contaminated test material, and sampling at fixed time intervals to determine whether growth of the organisms occurs or the preservative inhibits or kills the contaminants. The method is adaptable to multiple dose parenteral products, ophthalmic preparations, and oral or topical preparations. Where a preservative problem is involved, experience has shown that each new formulation should be examined. |