Nitrosamine Analysis
Nitrosamines are organic compounds with the general formula R2NNO or RNHNO found in a variety of foods and other products. They are a group of organic chemicals formed by the interaction of nitrites with amines or amides in the body and are potentially carcinogenic, and nitrosamine and N-nitroso compounds cause cancer in the liver and kidneys.
In the pharmaceutical industry, Nitrosamines can be formed in drugs from chemical reactions or during production. These chemicals are scientifically called N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
Products containing NDMA, NDEA, NMBA, NDEA and other components have been detected in more than 30 products in the drugs used in the treatment of hypertension, type II diabetes, and heart attack in the California Prob 65 list, and since it exceeds a certain limit, and this situation causes cancer in the human body. They were withdrawn from the market by the FDA due to.
With the first contamination cases reported in the summer of 2018, we are on track to perform analytical analyzes for nitrosamines to support our customers. 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 current approved methods for Pharmaceutical Raw Materials.
