Nitrosamines are formed by the nitrosation between nitrites or nitrates and amines or amides. The final molecule is the result of the addition of a nitroso radical and the formed compound is only stable with secondary amines.
Identification & Quantification of Nitrites and Nitrates
Ensure product safety with accurate Nitrites & Nitrates Testing
The presence of nitrites and nitrates in pharmaceutical manufacturing processes can lead to the unintended formation of nitrosamines, classified as potential carcinogens. Their formation occurs through nitrosation reactions, particularly when a precursor amine reacts with a nitrosating agent such as nitrite ions. Ensuring strict control of these substances is essential to meet regulatory requirements and guarantee patient safety.
Why analyze Nitrites and Nitrates?
The pharmaceutical industry must mitigate the risk of Nitrosamine Drug Substance-Related Impurities (NDSRIs) and other nitrosamine contaminants.
This involves controlling both the nitrite sources and amine precursors that may lead to their formation. Our analytical services help you:
- Prevent nitrosamine formation by detecting nitrosating agents in raw materials and intermediates
- Ensure compliance with regulatory guidelines from agencies such as the FDA and EMA
- Optimize manufacturing processes by identifying potential sources of nitrosation
- Improve product stability by assessing degradation risks related to nitrate and nitrite contamination.
Prevent nitrosamine formation by detecting nitrosating agents in raw materials and intermediates
Optimize manufacturing processes by identifying potential sources of nitrosation
Ensure compliance with regulatory guidelines from agencies such as the FDA and EMA
Improve product stability by assessing degradation risks related to nitrate and nitrite contamination.
Our Nitrites & Nitrates Testing Services
We offer comprehensive analytical solutions for the detection and quantification of nitrites and nitrates in pharmaceutical raw materials, intermediates, and final products. Our services include:
Trace-level detection using advanced analytical techniques such as IC (Ion Chromatography), LC-MS/MS (Liquid Chromatography-Mass Spectrometry), and UV-Vis Spectrophotometry.
Risk assessment for cross-contamination from solvents, catalysts, or production equipment
Quantification of nitrosating agents in active pharmaceutical ingredients (APIs), excipients, and packaging materials
Custom testing solutions tailored to your specific formulation and manufacturing conditions
Contact us for Nitrites & Nitrates Testing
If you need a trusted laboratory to analyze nitrites and nitrates in your pharmaceutical process, we can help!
Ensure compliance and product safety with our expert testing services.
📩 Contact us today to discuss your analytical needs and receive a tailored testing solution.
