Many organic impurities, such as nitrosamines, are known to be harmful to human health. Therefore, regulatory bodies and government set strict limits to protect us all. Even in small quantities, pharmaceutical impurities can have serious negative health impacts and influence the behaviour and efficacy of a drug. Organic impurities fall into a number of categories.

ICH M7 provides greater flexibility to assess the risk posed by Mutagenic Impurities.  This is described in section 8 – Control of the guideline and defined as a series of control options.  Of these Option 4 permits an applicant to present an argument for control based on the physico-chemical properties of a mutagen and the