Nitrosamines are a large group of N-nitroso compounds that share a common functional N-N=O group. They are produced by a chemical reaction between a nitrosating agent and a secondary or tertiary amine. Back in 2018, nitrosamines suddenly found themselves in the spotlight when they were unexpectedly detected in medications for high blood pressure. Since then, they have been found in several other prescription medications, including those for heartburn, acid reflux and diabetes, resulting in manufacturers recalling some common medications.
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Nitrosamines: Where are we now?
Nitrosamines are a large group of N-nitroso compounds that share a common functional N-N=O group. They are produced by a chemical reaction between a nitrosating agent and a secondary or tertiary amine. Back in 2018, nitrosamines suddenly found themselves in the spotlight when they were unexpectedly detected in medications for high blood pressure. Since then, they have been found in several other prescription medications, including those for heartburn, acid reflux and diabetes, resulting in manufacturers recalling some common medications.
Standard peaks are noisy
I am Using Sciex Qtrap 4500 for quantification of nitrosamines (NDMA&NDBA). I am facing issue with higher baseline intensity. When developed the method in APCI the basline was at about 5e4. but now even after cleaning the source (i.e. Changed capillary to new, Curtain plate & Corona needle cleaning, given blank injection overnight ), my base line decreased from 1e6 to 4 e5, but settled at 4 e5 from past 24 hours. can you suggest me how decrease my baseline intensity further to below 1e5. My standard peaks are like noise now.
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...
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