Toxicological overview of impurities in pharmaceutical products.
While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established. This chapter discusses practical and theoretical methods for qualification of different classes of impurities.
Jacobson-Kram
David
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Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. david.jacobsonkram@fda.hhs.gov
McGovern
Timothy
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D004340:Drug Contamination; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D009153:Mutagens / Q000032:analysis* / Q000633:toxicity; D004364:Pharmaceutical Preparations / Q000032:analysis*; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
D009153:Mutagens; D004364:Pharmaceutical Preparations