In the USP-NF-GC 1469 standard developed by the United States Pharmacopoeia (USP), a new general section has been designed to provide useful information for proper control of nitrosamine impurities in drug substances and drug products to protect patients from the adverse effects of nitrosamines as impurities. It has been announced that this standard will become official on 1 December 2021.
To protect patients and strengthen the global pharmaceutical supply chain, the United States Pharmacopoeia (USP) provides tools and solutions to analyze and monitor impurities in the pharmaceutical supply chain . Recent research has identified the presence of nitrosamine impurities in some medications used to treat high blood pressure and heart failure. Subsequently, nitrosamine impurities have been found in other medications as well, leading to significant efforts to reduce or eliminate their presence in the pharmaceutical supply chain.
All pharmaceutical manufacturers are responsible for controlling their production processes to detect and prevent the presence of unacceptable impurities. This includes developing approaches for using appropriate methods to detect and control these impurities, as well as other impurities that arise when modifying manufacturing processes.
The United States Pharmacopeia (USP) supports manufacturers and government agencies with tools and solutions for testing, risk assessment, and understanding potential sources of nitrosamine impurities.
Nitrosamines are chemical compounds commonly found in water and a variety of foods, including smoked and grilled meats, dairy products, and vegetables. People are exposed to some amount of nitrosamines in many ways. However, nitrosamine impurities are recognized as possible human carcinogens and should not be present in drugs, even at trace levels. They are part of a group of high potency mutagenic carcinogens called the anxiety group.
Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our company also provides testing services for the appropriate control of nitrosamine impurities in pharmaceutical substances and pharmaceutical products within the scope of USP-NF-GC 1469 standard, with its trained and expert staff and advanced technological equipment. gives.
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