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    Jun 2016
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Investigation of patent and grant data to support purge calculations of DNA reactive (mutagenic) impurities used for risk assessment

pdf fileWebb S; Stalford SA;

This poster was presented by Samuel Webb at the 2016 QSAR International Conference on Quantitative Structure-Activity Relationships.


Compounds introduced during synthesis including starting materials, intermediates and by-products may be carried through the synthesis to become impurities in the final product. If these are predicted or known to be mutagenic then they are subject to regulation under the ICH M7 guidelines. These guidelines allow for a chemistry-based argument that the impurity will not survive the synthetic route and evidence of its absence may then not be necessary.

Many impurities are highly reactive and thus will not typically survive subsequent synthetic and purification steps and therefore present negligible risk of carry over into the final product.

An approach to estimate the loss (purge) of a compound through a synthetic scheme has been described. In this concept, physicochemical properties such as reactivity, solubility and volatility can be combined to derive a theoretical purge for an impurity. Such an approach is used by several organisations within the pharmaceutical industry to support regulatory submission


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