Analysis of mutagenic impurities and nitrosamines in pharmaceuticals

The ICH M7 regulation plays a crucial role in the pharmaceutical industry, focusing on the management of mutagenic impurities in medicines. This guideline focuses on identifying and limiting carcinogenic risks, particularly in the evaluation and management of impurities that can affect DNA. It is essential to consider the impurities present or potentially present in the final products, evaluating their impact on the conditions of human use. ICH M7 highlights the need for balanced risk management, weighing both safety and quality, to determine acceptable levels of these impurities.

Among the impurities of interest, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), two carcinogenic impurities, were subject to careful monitoring. Since then, other N-nitrosamines have also been identified and are being investigated by regulatory agencies: N-Nitrosodiisopropylamine (NDIPA), N-Nitrosoethylisopropylamine (NEIPA), N-Nitrosodibutylamine (NDBA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). These compounds, frequently found in pharmaceutical products, require extensive monitoring and control to protect the health of patients. The ICH M7 regulation, together with other guidelines, establishes specific limits and detailed procedures for their identification and quantification. Accurate detection is vital, as even in small quantities, nitrosamines can pose a significant health risk.

At Netpharmalab we extend our services within the framework of the ICH M7 regulation with:

  • Detailed Risk Analysis: We thoroughly evaluate the mutagenic profile of impurities, using advanced techniques to set toxicological limits and ensure safety and regulatory compliance.
  • Development of Specialized Analytical Methods: We innovate in the creation and validation of methods to accurately detect nitrosamines and other impurities, guaranteeing exact and reliable results.
  • Rigorous Regulatory Compliance: We are dedicated to complying with ICH M7 and other regulations, committing to the quality and safety of pharmaceutical products.
  • Expert Advice: Our team of trained toxicologists provide personalized advice, supporting informed decisions in the management of mutagenic impurities.

Our commitment

We are committed to precision and excellence in nitrosamines testing, ensuring that your products not only comply with regulations, but also protect the health of consumers. Our rigor and advanced technology position us as leaders in the identification and management of mutagenic impurities, contributing to the safety and effectiveness of your products in the global pharmaceutical market.