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).

Pharma perspectives: The influence of LC-MS innovation on drug development outsourcing

It is no secret that (bio)pharmaceutical research and development is complex, both scientific and regulatory processes. Working for a contract research organization and more recently for SCIEX has provided an interesting perspective on trends the market experiences that affect many of us.

Overcoming uncertainty in your PFAS analysis

Just like gum on the bottom of a shoe, the existence of per- and poly-fluorinated alkyl substances (PFAS) in our environment is a sticky one. If you’re in the field of environmental testing, then you’re all too familiar with the threat these substances have on public health. While we have learned a lot about them over the years, there is still much more to understand. With the right detection methods, we can gather the information we need to empower us to make informed decisions on reducing the risks they impose.

6 Signs it’s time for a new vendor

A lab’s success depends on many factors from instrument quality to efficient operations, including being partnered with the right vendor. A vendor is more than just a supplier. They should provide you with a high-level quality of support in maximizing the lifespan and performance of your systems, reducing downtime, enhancing ROI and more. How do you know if you’re partnered with the right one? Here are six signs it might be time to find someone new.

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