Advanced Detection and Analysis: We utilize cutting-edge analytical techniques to detect and quantify nitroso impurities in APIs, key intermediates, and raw materials. Our methods include high-performance liquid chromatography (HPLC), mass spectrometry (MS), and other advanced technologies to accurately identify and measure these contaminants.

Detailed Impurity Profiling: Our comprehensive impurity profiling services provide in-depth analysis of nitroso impurities. We evaluate their concentration, chemical nature, and potential impact on the safety and efficacy of the final pharmaceutical product, delivering detailed reports to guide decision-making.

Regulatory Compliance: Ensuring compliance with global regulatory standards is critical for product approval and market acceptance. We adhere to stringent regulatory guidelines, including those from the FDA, EMA, and ICH, to manage nitroso impurities effectively. Our services include providing necessary documentation and support for regulatory submissions and approvals.

Mitigation and Control Strategies: Addressing nitroso impurities requires effective control strategies. We develop and implement tailored solutions to minimize and manage these impurities, including process optimization, purification techniques, and rigorous quality control measures. Our goal is to reduce impurity levels and enhance the overall quality of your pharmaceutical products.

Expert Consultation and Support: Our team of experts offers technical consultation and support throughout the impurity management process. We assist with interpreting analytical results, developing mitigation strategies, and resolving any challenges associated with nitroso impurities.