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Regular analysis of pharmaceuticals

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.

 

Support

 

Today, Tentamus is one of the leading independent contract laboratories in the field of drug analysis and medical device testing. Our customers include national and international companies from the fields of industry, research and development, as well as the approval and quality control of pharmaceuticals and medical products. We carry out chemical-physical, analytical, microbiological and mechanical tests for our customers at a total of ten locations in Europe, Israel, China and the USA.

We support your company in the development, approval or quality control of your pharmaceutical products.

Contact

 

Dr. Yvonne Pfeifer
yvonne.pfeifer@tentamus.com
+49 30 206 038 164

 


Sources: BfArM und Spiegel Online

 

Source: https://www.tentamus.com/analysis-pharmaceuticals/

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