Nitrosamine analysis

Monitor, control, and prevent nitrosamine impurity contamination

Unacceptable levels of N-nitrosamine impurities, which may increase the risk of cancer, have been found in some types of medications. This resulted in drug recalls, warning letters and drug shortages.

Whether your company has been directly impacted or not, proposed future EMA and FDA regulations will require more stringent detection of these genotoxic impurities (GTIs) for products sold in their markets.

Discover how we can help you identify and quantify nitrosamines and other genotoxic impurities today.

Request Pricing Ask us more

zoom

Overview

Literature

Application Notes

Learn more about the nitrosamine crisis in the pharmaceutical industry

Download our white paper.

This white paper helps understand the current status and causes of contamination of pharmaceutical products by the genotoxic impurities known as nitrosamines.

Start with Chemistry

Use of a Proprietary Polar Column Chemistry for the Separation of Nitrosamines in Sartan and Ranitidine Drug Substances.

Download the technology brief.

Discover our solutions:

ACQUITY HSS T3 and XSelect HSS T3 Chemistry (available in 1.8 um, 3.5 um and 5 um particle sizes)
and Atlantis PREMIER BEH C18 AX Column

Quickly analyze impurities using HPLC/UV

Learn about a quick analysis of N-nitrosodimethylamine (NDMA) in Ranitidine drug substance and drug product by HPLC/UV.

Download the technology brief.

Discover our solutions:

Quantify low-level impurities with UPLC-MS/MS

Discover a highly sensitive method for LC-MS Analysis of Ranitidine Drug Product.

Download the application note.

Discover our solutions:

Increase HRMS selectivity and screen for unknowns

Development of a Sensitive High Resolution Mass Spectrometry Method for Quantitation of N-Nitrosamines using Tof MRM on the Xevo G2-XS QTof.

Download the application note.

Employing UPLC-UV-ToF MSE and the UNIFI Scientific Information System for the Analysis of the Forced Degradation of Glipizide.

Download the application note.

Discover our solutions:

How to achieve sensitive and accurate quantification of nitrosamine impurities from complex drug substance or product?

Discover a sensitive and robust method presented by Mary Trudeau Lame, Principal Applications Scientist, Waters Corporation.

Watch the video!

Contact Waters

Request Pricing Ask us more

Local Offices

Webinar: How to Avoid the Next Nitrosamine Crisis
Access now.

Mutagenic Impurity Risk Assessment Throughout the Development and Manufacturing Process
Read the full blog here.

The Current Concerns About Genotoxic Impurities Found in Commonly Used Prescription and Over The Counter Pharmaceutical Drugs:
Read the full white paper now.

Method Lifecycle Management: Keep Your Method Fit for Life.
Visit the microsite now.

The Nitrosamine Crisis Podcast - Controlling Risk: An Industry Leader's Perspective
Listen to episode 1