How do I set up my processing method to calculate the RRT of the main peak to 10kD in karat 32 software?
QA/QC
Quality control or analysis
What have we learned from the nitrosamine crisis?
The pharmaceutical industry is facing an ongoing issue with genotoxic impurities (GTIs). Over the past year, we have witnessed genotoxic impurities affect several drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. Angiotensin II...
Developing a method for nitrosamine analysis in pharmaceutical products
In our previous blogs we discussed the need for a more comprehensive approach for monitoring contaminants in finished drug products.1,2 Here we cover a generalized approach for the targeted, quantitative LC-MS/MS analysis of several commonly encountered nitrosamines in pharmaceuticals and ways to address specific challenges with their analysis.
Are we proactively solving the nitrosamine crisis?
In my previous blog, I spoke about the FDA recall of angiotensin II receptor blockers like losartan. This recall was due to the presence of genotoxic nitrosamines. Is a proactive approach the way to mitigate risk? Recently, the FDA has re-issued the 2018 guidance to...