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A much abbreviated shortlist of remaining materials of concern is likely to have resulted from having compiled an initial list of potential impurities, identified those that are known or suspected mutagens, and evaluated which of these may potentially be present in API at a level of concern, based on the material characteristics, origin in the process, and ability to survive the process intact.

There are now two ways by which the risk of such remaining potential PMIs may be mitigated.

1 Safety testing. Demonstrating that a material is nonmutagenic will allow it to be addressed under ICH Q3A/B.

2 Analytical testing. Demonstrating that a material is below the permitted safety limit.

Which approach to take will depend on the specific nature of the project and the impurity concerned and may be influenced by factors such as the availability of pure samples of the material of concern and/or availability of appropriate analytical methodology with which to determine levels.