Nitrosamine Analysis
R2They are organic compounds with the general formula NNO or RNHNO. They are a group of organic chemicals formed by the interaction of nitrites with amines or amides in the body and are potentially carcinogenic. Nitrosamine and N-nitroso compounds cause cancer in the liver and kidneys. Products containing NDMA, NDEA, NMBA, NDEA and other components have been detected in more than 30 products in drugs used in the treatment of hypertension, type II diabetes, and heart attack. Angiotensin II receptor blockers valsartan and some of the drug products containing this active substance, with the detection of nitrosamines in June 2018, started controls by international authorities (FDA and EMA).
In September 2019, tetrazole ringed sartans As well as the presence of N-nitrosamines in other active substances/medicinal products, an investigation has been initiated by the EMA on the detection, management and prevention of the presence of N-nitrosamines in medicinal products for human use pursuant to Article 5 (3) of Regulation (EC) No 726/2004 .
FDA and EMA have published guidelines to determine acceptable levels of these nitrosamine impurities and have started a study with industry to control products that are on the market or will be released.
In this context, international health Along with the authorities, Turkish Medicines and Medical Devices Agency (TİTCK) requests evaluations from companies for all medical products on the market. we are moving forward. In accordance with GLP standards, we aim to provide services in many areas such as providing new analytical methods, Method Development and Method Validation or Routine Tests according to existing approved methods in drug active and auxiliary substances and finished products.
