Elemental Impurities: new USP chapters

Impact Analytical

Drug products and dietary supplements for the US market will soon have to comply with the new elemental impurities requirements and testing set forth by the USP General Chapters <232> Elemental Impurities—Limits, <233> Elemental Impurities—Procedures, and <2232> Elemental Contaminants in Dietary Supplements. The USP recognized that the current chapter <231> Heavy Metals was obsolete, and it will be eliminated completely on 1/1/2018, when the new chapters will be officially implemented.

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