Risk of presence of mutagenic azido impurities in sartan active substances with a tetrazole ring


Strasbourg, France

Following recent investigations demonstrating the mutagenicity of an azido impurity in sartan active substances (APIs) with a tetrazole ring, the EDQM confirms that the CEP holders concerned have already been contacted and have addressed the issue as requested.

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.

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.

The EDQM reminds CEP holders that they should provide the appropriate information relating to the risk identification they have performed for their CEP to their customers.  The marketing authorisation holders will then be able to use this information to fulfil their legal responsibilities.