Four Steps of Analysis of Elemental Impurities in Drugs
From January 1, 2018, the United States Pharmacopeia (USP) requires that all new drugs and generic drugs, whether they are on the market or under review or to be declared, must meet the requirements of the General Principles for the Control of Elemental Impurities Limits (USP<232>). To perform elemental impurity analysis, below are some necessary steps that should be considered. The first...
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