Identification of nitrosamines in pharmaceutical products
Nitrosamine screening is a rapid and extremely sensitive laboratory test that can detect even trace amounts of these potentially carcinogenic compounds in active pharmaceutical ingredients (APIs), finished pharmaceutical products and excipients.
The analysis allows detection of both low-molecular-weight nitrosamines, such as NDMA, NDEA, NDBA, as well as nitrosamines formed by reaction with an active substance (so-called nitroso-API). This allows for a comprehensive risk assessment of the presence of these contaminants.
The use of nitrosamine screening is particularly important at the product development stage and in routine quality control. This test allows verification of any newly developed formulation for the potential risk of nitrosamine formation. In addition, this analysis is used in product stability studies, allowing for ongoing control of the formation of nitrosamines during storage.
Nitrosamine screening – key benefits
Performing nitrosamine screening carries a number of significant advantages:
- Analytical confirmation of risk analysis results – allows verification of the consistency of theoretical assumptions with the actual pollution profile.
- Identification of unexpected nitrosamines – allows detection of the presence of other compounds than those predicted at the risk assessment stage.
- Confirmation of the absence of nitrosamines during stability testing – supports the safety of the product at every stage of its life cycle.
- Information on nitrosamines formed during the production process – allows changes in formulation and technology, which can eliminate the need for routine monitoring of nitrosamines in the future.
Today, screening for nitrosamines is an indispensable part of quality and compliance strategies for the EMA, FDA and ICH – both at the product development stage and in routine monitoring.
Why cooperate with our laboratory?
- Very high sensitivity – can detect trace amounts of nitrosamine contamination at ppt/ppb levels
- Reliable results – data analysis based on advanced databases and aggregate pattern matching algorithms
- Individual approach to the customer – flexibility, fast implementation and full substantive support
Contact us
Contact us for a free quote and to see how we can support your project.
We offer fast and sensitive screening analysis of nitrosamines by LC-HR-MS/MS technique to detect even trace amounts of these compounds in active pharmaceutical ingredients (APIs), finished products and auxiliary raw materials.
See also: Determination of nitrosamines
