Impurity Identification and Characterization: Our advanced analytical techniques allow us to accurately identify and characterize related impurities in APIs, key intermediates, and raw materials. We utilize sophisticated methods such as chromatography, mass spectrometry, and spectroscopy to detect and quantify these impurities, ensuring that all relevant impurities are accounted for.

Comprehensive Analysis: We perform thorough analysis to determine the nature and concentration of related impurities. This includes understanding their potential impact on the quality and safety of the final pharmaceutical product. Our detailed reports provide insights into impurity profiles and help guide formulation and manufacturing decisions.

Regulatory Compliance: Adherence to regulatory standards is crucial for successful product approval. We ensure that our impurity analysis and control measures comply with global regulatory requirements, including those set by the FDA, EMA, ICH, and other relevant authorities. We provide documentation and support to facilitate regulatory submissions and ensure compliance.

Control and Mitigation Strategies: Effective management of related impurities involves implementing control and mitigation strategies. We develop customized solutions to manage impurity levels, including process optimization, purification techniques, and quality control measures. Our strategies aim to minimize the impact of impurities and enhance the overall quality of APIs, intermediates, and raw materials.

Technical Consultation and Support: Our team of experts offers technical consultation and support throughout the impurity management process. We assist with interpreting analytical data, developing control strategies, and addressing any impurity-related challenges that arise during product development and manufacturing.