Genotoxic Impurities are chemicals that can harm by causing damage to DNA. Regulatory agencies worldwide require thorough testing for these impurities. We can help you ensure compliance to safeguard consumer health.
- Our process involves the comprehensive development, validation and analysis of genotoxic impurities, meticulously assessing them against allowable maximum daily exposure targets.
- We do testing according to ICH M7 (R1), USFDA, EMA and customer requirements for Identification and quantification.
Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. Nitrosamine impurity testing is crucial in order to remain in compliance with health organizations. Nitrosamines can become part of pharmaceutical product during various stages of manufacturing. A vigorous test method is necessary to detect nitrosamines. Our expertise and capabilities can make sure your products do not exceed the daily intake limits.
Our expertise in dealing with method development and validation of Nitrosamine / NDSRI impurities with a focus to resolve key method optimization challenges and ensure precise & reliable results. With advance we hyphenated mass spec instruments, we develop methods for comprehensive screening and quantification of nitrosamines with sensitivities reaching up to sub ppb levels. Energon Labs can also develop methods for new nitrosamine impurities identified by the FDA. We stay up-to-date with the latest industry standards and technology advancements in N-nitrosamine impurity analysis.
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