Nitrosamines refer to any molecule containing a nitroso functional group. These molecules are of concern because nitrosamine impurities are possible human carcinogens. Nitrosamine impurities are also found in some foods and drinking water sources, but their presence in medicines is unacceptable.
A regulation for the control of nitrosamine impurities in drugs has been published by the American Food and Drug Administration (FDA) to ensure the safety of drug supply. The purpose of this regulation is to identify the steps that pharmaceutical companies should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. This regulation also includes the root causes causing nitrosamine impurities.
Accordingly, pharmaceutical companies must have appropriate control strategies to prevent or limit the presence of nitrosamine impurities and improve their production processes where necessary. Manufacturers must understand the potential sources of nitrosamine formation in their production processes and take appropriate measures to reduce the likelihood of these carcinogenic impurities forming . The pharmaceutical industry, in particular, needs to understand that the quality of reagents and solvents is critical to guaranteeing the quality of the final pharmaceutical material.
At the request of the European Medicines Agency, marketing authorization holders have conducted risk assessment and confirmatory testing on the potential risks of pharmaceutical products containing chemically synthesized active substances, containing nitrosamine impurities. Regulators set intermediate limits based on the maximum daily intake. Limits will be lowered in the future, with the expectation that manufacturers will guarantee an almost complete absence of nitrosamine impurities. For example, after a two-year transition period with sartan, the limits were set at 0,03 ppm.
Nitrosamines are difficult to analyze. Ultra-low levels of these impurities are measured in various and complex matrices. Developed methods must then be validated to comply with good manufacturing practice requirements. Advanced laboratories are equipped with the necessary equipment to meet these limits, including the LC MSMS and GC MSMS systems. Both toxicological and analytical support is provided for risk assessment.
Our company also provides nitrosamine impurity analysis services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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