EDQM 沙坦类四唑环API中出现致突变叠氮杂质的风险20210429

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最近调查证明沙坦类四唑环API中的一种叠氮杂质具有致突变性，EDQM在此确认已联系相关CEP持有人，这些持有人已按要求解决此问题。

The review of the data received, performed according to the requirements of ICH M7, shows that only a few sources are concerned and appropriate actions are being taken to ensure that the level of azido impurities is below the threshold of toxicological concern (TTC) in these sources.

收到数据后，我们根据ICH M7的要求进行了审核。审核显示只有少数来源令人担忧，但已采取适当措施确保叠氮杂质的水平低于这些来源的毒性关注阈值（TTC）。

If confirmatory testing reveals that batches of APIs currently on the market exceed the applicable TTC limit, actions (e.g. suspension) may be taken by the EDQM for these CEPs.

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