As you know impurities have been a major concern for many Pharma companies in the recent past and regulatory bodies like USDA, MHRA and recently IPC in India is increasingly working on scrutinizing the drug batches. Regulators or trying to evaluate the limits and defining the requirements for drug products as well as drug substance and evaluating them requires a robust workflow.
We would like to share strategies for successful nitrosamines analysis as a resource hub which could be beneficial for you and your peers. Here is a link to our nitrosamines resource hub that will help you in understanding the concerns about genotoxic impurities found in commodities, high sensitivity quantification of nitrosamines in a drug product, a demo with technical notes and dedicated webpage to nitrosamines analysis.
https://bit.ly/3UVo0ob