Dealing with regulatory questions related to N-nitrosamines

N-nitrosamines are a class of highly carcinogenic compounds that have been identified as impurities in a number of drugs. The presence of N-nitrosamines in drugs can pose a significant risk to public health, as prolonged exposure can increase the risk of cancer and other adverse health outcomes. This is why the pharmaceutical industry is working with a high level of effort to assess the risk of the presence and control of N-nitrosamines from their drugs.

There are several factors that contribute to the formation of N-nitrosamines in drugs, including the use of certain raw materials, the manufacturing process, and storage conditions. Raw materials that contain nitrosamines or precursors of nitrosamines, can lead to the formation of N-nitrosamines in the final product. The API manufacturing process can also play a role, as certain conditions such as high temperatures, pH, or exposure to nitrites. To mitigate the risk of N-nitrosamines, it is essential that pharmaceutical companies implement robust quality management systems and risk mitigation measures throughout the entire supply chain. This includes monitoring the purity of raw materials, controlling manufacturing conditions, and implementing proper storage and handling procedures.

Additionally, it is important to have tools and resources to deal with the eventual presence of N-nitrosamines.

Altox’s consultancy provides solutions to these challenges by offering a fast and efficient way to deal with regulatory questions related to the presence of N-nitrosamines. With softwares and experts with advanced knowledge to analyze the risk level and accurately calculate limits for N-nitrosamines in drugs, strategy design by computational methods to mitigate formation of N-nitrosamines by specific cause roots. In addition, Altox’s software can be used to predict purge in case of formation in synthetic routes providing valuable. This not only speeds up the regulatory process but also provides more reliable results to patients and your organization.

Know more:

DARAN (Defined Approach for Risk Assessment of New Nitrosamines)

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