Merck shares the page for information about nitrosamine risk assessment.
The page includes the following;
- The Formation of Nitrosamines
- Prevalence of Nitrosamine Precursors in Pharmaceuticals
- Methods for Nitrite Quantification
- Sources of Nitrites in Excipients
- Categorizing EmproveĀ® Products Based on Nitrite Levels
I want to focus on the last section. It will be helpful for risk assessment. However, I could not find information about nitrite levels in the Demo Dossier.
Categorizing EmproveĀ® Products Based on Nitrite Levels
More than 350 products contained within the EmproveĀ® Essential, the EmproveĀ® Expert and the EmproveĀ® API portfolio, have been assessed for the presence of nitrites and grouped into three categories based on their level of nitrite.
- Nitrite concentrations less than 200 ng/g or below the LOQ: are low level of risk for introducing a relevant level of nitrites into a process.
- Nitrite levels between 200 and 500 ng/g: the presence of nitrites has been detected in at least one batch and these products are periodically tested to monitor nitrite levels. These products are of moderate concern.
- Nitrite levels >500 ng/g in at least one batch. While this is mostly in the sub-ppm, range additional control steps are being applied and more batch data are being collected to derive a feasible limit and method for regular control.
Information related to the presence of nitrite is provided in the EmproveĀ® Material Qualification and Operational Excellence dossiers that accompany these products. This information supports risk assessments of nitrosamine formation in drug products and provides drug manufacturers with valuable information to mitigate risk from nitrosamines and improve drug safety for patients. Download free EmproveĀ® chemicals demo dossiers.