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Update on the review of CEP applications for sartans and the availability of test methods for nitrosamines

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News
17 October 2018
Strasbourg, France

Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active substances. The EDQM contacted those manufacturers of valsartan and other sartans holding CEPs which might have presented a risk of contamination with nitrosamines, including NDMA and NDEA (N-nitrosodiethylamine). Both contaminants are classified as probable human carcinogens (substances that may cause cancer).

Since taking action for those substances that were at greatest risk of contamination, the EDQM has continued to assess the data received from all manufacturers concerned and to ensure that appropriate controls are put in place. Evaluation of the data received is prioritised on the basis of risks. Once assurance has been obtained that there is no risk of contamination (if needed, after an additional request for information), the EDQM issues either a letter confirming that the review of the CEP application has been completed or a revised CEP.

For analytical testing methods please consult the methods for determination of NDMA and NDEA in sartans.

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