Important Note

• Assessment of the mutagenic potential of impurities presented here does not intended for the following types of drug substances and drug products: biological/biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation products, herbal products, and crude products of animal or plant origin. This also does not apply to drug substances and drug products intended for advanced cancer indications as defined in the scope of ICH S9 (Ref. 4). Additionally, there may be some cases where a drug substance intended for other indications is itself genotoxic at therapeutic concentrations and may be expected to be associated with an increased cancer risk. Exposure to a mutagenic impurity in these cases would not significantly add to the cancer risk of the drug substance. Therefore, impurities could be controlled at acceptable levels for non-mutagenic impurities.
• Assessment of the mutagenic potential of impurities as described here does not intended for excipients used in existing marketed products, flavoring agents, colorants, and perfumes. Application of this guideline to leachables associated with drug product packaging is not intended, but the safety risk assessment principles outlined in ICH M7 guideline for limiting potential carcinogenic risk can be used if warranted. The safety risk assessment principles of ICH M7 guideline can be used if warranted for impurities in excipients that are used for the first time in a drug product and are chemically synthesized.

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