Neil Walsh

What have we learned from the nitrosamine crisis?

Jan 30, 2023 | Blogs, Development, Pharma, QA/QC | 0 comments

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 receptor blockers (including valsartan, losartan and irbesartan), along with ranitidine and nizatidine, were recalled to investigate several potentially cancer-causing substances, called nitrosamines. The FDA knows this is an issue that has resulted in regulatory actions and loss of revenue for the manufacturers.

Amid this crisis, companies are realizing they need to address the wider issue of active pharmaceutical ingredient (APIs) quality for drugs currently on the market. Companies must concern themselves with the accurate identification, quantification, and monitoring of impurity levels. They must take a proactive approach to verify the quality of the product and the materials used in the manufacturing.

The regulators currently require this type of quality analysis for those products affected by the nitrosamine crisis. The requirement is not just for the GTIs, but also for the other products and processes in the manufacturer’s portfolio and pipeline. Both the FDA and European Medicines Agency have issued guidance for the impurity detection levels in the angiotensin II receptor blocker based on daily dosage, but the quantitative limit of detection will become even more challenging—going to 0.03 ppm by early 2021. The ability to reach that level of detection will require the highest levels of sensitivity, to help ensure that manufacturers can verify final products before they go to market.

You can learn more about how LC-MS/MS solutions can identify, quantify and monitor the required levels of nitrosamine impurities by accessing technical notes and a webinar addressing the characterization and quantification of the genotoxic impurities. Learn More >

This blog is part 1 of a 3-part series on nitrosamine analysis. Read part 2 (Are we proactively solving the nitrosamine crisis?) and part 3 (Developing a method for nitrosamine analysis in pharmaceutical products).

Understanding PFAS and its impact on U.S. drinking water

In recent years, per- and polyfluoroalkyl substances (PFAS), often referred to as “forever chemicals,” have become a growing topic of interest due to their persistence in the environment and potential health risks. These synthetic compounds have been widely used in various industrial applications and consumer products since the 1940s. PFAS can be found in the air, soil, and water, and studies have shown that most people have detectable levels of PFAS in their bloodstream. One of the main exposure pathways for humans is through drinking water, particularly in communities located near industrial sites, military bases, or areas where firefighting foam has been used.

Selecting an LC-MS system for quantitation of pharmaceutical drug development

We understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created a solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options.

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.

Posted by

Neil Walsh

Neil Walsh is the Senior Manager for Pharma global strategic marketing at SCIEX. In this role, he manages both the strategic market and marketing for the pharmaceutical industry. Neil has spent all his working life entrenched in the pharmaceutical industry from active research, sales and business development through to strategic marketing. Outside of work Neil enjoys rugby, cycling and spending time with his family

0 Comments