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〈466〉 Ordinary Impurities

This test, where called for in the individual monograph, is provided to evaluate the presence of ordinary impurities in official articles. Ordinary impurities are defined as those species in drug substances and/or drug products that have no significant, undesirable biological activity in the amounts present. These impurities may arise out of the synthesis, preparation, or degradation of compendial articles. In certain instances, impurities that pose a potential health risk may be detected. Because these impurities would not be individually identified by the strict use of this General Chapter, a separate evaluation may be necessary to ensure that the detected impurities fit the requirements set forth in the definition of Ordinary Impurities. Selections of tests and assays allow for anticipated amounts of impurities that are unobjectionable for the customary use of the article.

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