The active pharmaceutical ingredient Valsartan is currently under critical observation and investigation. At the beginning of June its contamination with a potentially carcinogenic substance (N-nitrosodimethylamine (NDMA)) was discovered. The active ingredient valsartan is used in drugs to regulate high blood pressure.
How can the substance NDMA enter the active ingredient?
The active ingredient valsartan is produced by a synthesis process. Changes in this process may cause NDMA to form as a by-product. NDMA can result from an acid-catalyzed reaction of dimethylamine with nitrite salts.
How is the production of active ingredients monitored?
The internationally established rules of good manufacturing practice (GMP) are mandatory for the manufacture of active pharmaceutical ingredients. Regular on-site audits by GMP-certified companies confirm compliance with good manufacturing practices.
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yvonne.pfeifer@tentamus.com
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Sources: BfArM und Spiegel Online
Source: https://www.tentamus-web.com/analysis-pharmaceuticals/