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Safety Based Limits for the Control of Impurities in Drug Substances and Drug Products: A Review

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  • Elder DP

    (David P Elder Consultancy, Hertford, United Kingdom)

Abstract

Safety based impurity limits are key to the effective reduction and control of impurities in medicinal products. Impurity limits now have a greater focus on daily exposure limits, with the introduction of various approaches, such as permitted daily exposure (PDEs), acceptable intake (AIs), threshold of toxicological control (TTCs) and staged TTCs all aimed at defining a virtually safe dose (VSD). This in turn led to the introduction of less than lifetime (LTL) limits for mutagenic impurities, which is based on an application of Haber’s law which states that concentration and exposure times are both critical for assessing likely safety risk to patients. Surprisingly, LTLs have not been applied to the other specific classes of impurities or indeed general impurities.

Suggested Citation

  • Elder DP, 2017. "Safety Based Limits for the Control of Impurities in Drug Substances and Drug Products: A Review," Global Journal of Pharmacy & Pharmaceutical Sciences, Juniper Publishers Inc., vol. 1(4), pages 109-116, April.
    • Handle: RePEc:adp:jgjpps:v:1:y:2017:i:4:p:109-116
    DOI: 10.19080/GJPPS.2017.01.555570
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