Nitrosamine Studies

Starting in 2018, nitrosamine testing became mandatory, requiring pharmaceutical manufacturers to meet criteria for sensitivity and selectivity. Because nitrosamines can form during both API and drug product manufacturing, the timing of the analysis is a central question for our customers. We believe the risk of impurity formation should be evaluated starting from API synthesis to final drug packaging. Analytical testing requires highly sensitive approaches to quantify nitrosamines in the low ppm levels (or lower) to fulfill regulatory requirements, and selectivity is critical to avoid false positive non-compliant results. At Cambrex, we specialize in advanced detection methodologies and use highly sensitive analytical instrumentation to detect and quantify these trace levels of nitrosamines.

Our team of experts conducts nitrosamine testing using state-of-the-art analytical equipment, including GC-MS (EI and APCI sources) and LC-MS/MS tandem mass spec (QQQ and Q-TOF). Our Durham, NC team has extensive experience detecting a full range of impurities, identifying potential risk factors and ensuring your product is safe and compliant. If nitrosamines are detected, we will work with you to implement risk-mitigating measures. As an integrated team, we will help you to gather all the required data and determine the best strategy to mitigate the formation of such compounds in your API, as well as cross-contamination of equipment, packaging and other elements in the manufacturing process. At Cambrex, we’ll help you navigate the challenges associated with nitrosamine testing.