Background:
In both 2018 and 2019 the presence of N-nitrosamines was found in sartans with a tetrazole ring but it was also detected in other API/medicinal products (e.g. in some batches of pioglitazone and ranitidine). Since N-nitrosamines are probable human carcinogens, the presence of these compounds in human medicinal products should be mitigated as much as possible.
Updates:
The above updates allow pharmaceutical companies from now on to define a common strategy for the Nitrosamines Risk Assessment process.
Asphalion can give you support in the preparation of the Risk Assessment for presence of Nitrosamine content.
We offer a global service that covers risk analysis, analytical phase and includes regulatory support with variation management. The end of the year is around the corner, so do not hesitate to contact us at info@asphalion.com in order to obtain specialized advisory and support!
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