Guidelines for the assessment and control of mutagenic impurities in pharmaceuticals
Masamitsu Honma · 2025
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Description
Honma reviews the world rules for finding and limiting DNA-damaging impurities in medicines. Drugs can carry trace leftovers from making or breaking down the product. Some of these can damage DNA, and even tiny amounts may raise cancer risk. A global guideline, ICH M7, was set in 2014 to give firms a shared method. It was updated in 2017 and 2023, with added intake limits for single compounds.
Recent cases of nitrosamine impurities showed the need for sharper risk methods. These compounds carry high cancer potential and turned up in common drugs. A further revision will add a way to weigh how strongly such impurities act. Honma traces how the rules evolved and where they head next.
Catalog record
| CREATOR | Masamitsu Honma |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 44 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |