Valsartan is used mainly in the treatment of mild to moderate hypertension of different etiologies.

A few months ago, the withdrawal of several production lots of Valsartan was announced due to the presence of n-Nitrosodimethylamine (NDMA). This impurity has been classified as "probably carcinogenic to humans" and is believed to have been introduced during the API manufacturing process.

This seminar showed the possibilities of analysis of NDMA in Valsartan, by GC / MSD, as well as new approaches to other mandatory GC/MS analyses.

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