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).

How LC-MS laboratories in regulated environments can build a strong foundation for reliable data, audit readiness and lifecycle control

Whether supporting pharmaceutical quality control, bioanalysis, clinical research, environmental testing, or food safety applications, regulated laboratories share a common responsibility: ensuring reliable data, maintaining audit readiness, and controlling systems throughout their lifecycle. Yet when compliance discussions arise, attention often moves quickly to audits, documentation, electronic records, and standard operating procedures. These elements are essential, but they depend on a more fundamental question: Can the analytical system consistently produce reliable results?

Future-proofing pesticide testing: Why speed is becoming a competitive advantage

Food testing laboratories face growing pressure. Pesticide panels continue to expand, regulations evolve, and customers still expect fast turnaround times at a competitive cost.

Celebrating customer experience: Insights from SCIEX leaders

Customer Experience Day (CX Day) is a special occasion for SCIEX, celebrated every first Tuesday in October. It’s a day dedicated to recognizing the incredible value of our customers and the relentless dedication of our associates who strive to make every interaction meaningful. At SCIEX, our commitment to customer experience is woven into the fabric of everything we do. From providing cutting-edge solutions to offering unwavering support, we aim to build lasting relationships and exceed expectations. Join us as we delve into the insights from our leaders on what customer experience means to SCIEX and how it shapes our journey.

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