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2.4.3.2 Question 3.2
Оглавление| Question | Answer |
|---|---|
| Should mutagenic, noncarcinogenic impurities be controlled according to ICH M7? | No. Mutagens that are demonstrated to be noncarcinogenic in appropriate and well‐conducted animal bioassays will be treated similarly to Class 5 impurities. |
This question clarifies the scenario where the stakeholder may consider a compound as a Class 3 impurity, without taking into account the negative carcinogenicity. The answer to this question tells you that such a compound does not need to be controlled as a mutagenic impurity and that for all matters of control, it can be treated similarly to nonmutagenic impurities. The rationale behind this is because the ultimate concern with mutagenic impurities is their potential to cause cancer, so if it has been shown that the compound is noncarcinogenic, even if it is mutagenic, the primary concern is eliminated and the mutagenic properties are irrelevant.
