Swissmedic laboratory publishes test method for nitrosamines in sartans

14.12.2018

Test method for active substances and finished medicinal products

Following the recall of sartan-containing medicinal products due to contamination with nitrosamines, Swissmedic's own OMCL (official medicines control laboratory) has been testing other sartans with a similar chemical structure. The Swissmedic laboratory has developed a sensitive test method for these substances. This method can be used to establish whether the content of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) is above or below the safety limit.

The analytical procedure for detecting the nitrosamines NDMA and NDEA is complex, and developing suitable test methods is therefore time-consuming. To enable sensitive tests to be introduced swiftly, Swissmedic has decided to publish its analytical method.

Swissmedic will require the Swiss authorisation holders of all sartan-containing medicinal products with the active substances candesartan, irbesartan, losartan, olmesartan and valsartan to perform systematic tests for the nitrosamines NDMA and NDEA. In future, all deliveries of the above-mentioned active substances received by these companies will have to be analysed.

The publication of the test method (limit test) is intended to enable the companies to establish a sufficiently sensitive and specific test procedure and thus help to avoid shortages of supply.

Related documents

Safety limit test method for NDEA/NDMA in sartans (PDF, 87 kB, 07.12.2018)(the document is currently only available in German)

Further links

Last modification 14.12.2018

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