Genotoxic & Nitrosomine Impurities
At Cubic Analytical Solution, we recognize the growing concern around nitrosamine impurities in pharmaceuticals and other industries. Nitrosamines, classified as potential carcinogens, pose significant health risks, making it essential to detect and control their presence in products. Our Nitrosamine Impurities Analysis services provide precise and reliable detection to ensure the safety and compliance of your products with industry standards.
- by LCMS & GCMS
- ICH M7 guidelines on genotoxic impurities and ICH Q3D on elemental impurities are useful frameworks for evaluating and controlling nitrosamines
- ICH M7 and ICH Q3D
- FDA Guidance on Nitrosamines (2019): Details steps for risk assessment and testing
Detecting and Mitigating Nitrosamine Impurities
Comprehensive Nitrosamine Testing
We offer specialized testing for nitrosamine impurities using advanced techniques like LC-MS and GC-MS. These methods enable sensitive detection and quantification of nitrosamines at trace levels. Our analysis covers a wide range of compounds, ensuring your products are free from harmful contaminants.
Importance of Nitrosamine Analysis
Nitrosamines can form during the manufacturing process, particularly in pharmaceuticals, where certain conditions and ingredients may lead to their development. Due to their carcinogenic potential, regulatory agencies such as the FDA and EMA have set stringent limits for nitrosamine levels in drugs.
Customizable Solutions
We understand that different products and manufacturing processes require tailored testing approaches. Our nitrosamine analysis services are customized to meet your needs for routine quality control, product development, or regulatory submission. We work closely with you to develop a testing strategy that aligns with goals.
Regulatory Compliance Support
Navigating regulatory guidelines related to nitrosamine impurities can be complex. Our expert team provides comprehensive support to ensure your products meet all necessary standards and regulations. We assist with compliance documentation, helping you meet the requirements set by agencies such as the FDA, EMA & ICH.
Expert Consultation and Support
In addition to our testing services, we offer expert consultation to help you understand the implications of nitrosamine impurities in your products. Our team provides guidance on how to minimize the formation of nitrosamines during manufacturing and how to implement effective controls.
Why Choose Us?
Our experienced team is committed to delivering accurate and reliable nitrosamine impurity analysis, utilizing state-of-the-art technology to ensure precise results. We prioritize quality control and client satisfaction, working closely with you to provide customized solutions that ensure the safety and compliance of your products.