Nitrosamine Impurities Analysis by LC-MS/MS
Tamil Nadu Test House offers advanced Nitrosamine Impurity Analysis for pharmaceutical products using high-performance LC-MS/MS (Liquid Chromatography–Tandem Mass Spectrometry). Our highly sensitive analytical platform enables the detection and quantification of nitrosamine impurities at trace levels, supporting pharmaceutical manufacturers in meeting stringent global regulatory requirements.
We provide testing for Active Pharmaceutical Ingredients (APIs), finished formulations, intermediates, and raw materials, with validated analytical methods designed to deliver accurate, reproducible, and reliable results.
Nitrosamines are a class of organic compounds containing the N–N=O (nitroso) functional group. Many nitrosamines are classified as probable or possible human carcinogens based on animal studies and toxicological evaluations.
Some of the commonly monitored nitrosamines include:
- N-Nitrosodimethylamine (NDMA)
- N-Nitrosodiethylamine (NDEA)
- N-Nitrosoethylisopropylamine (NEIPA)
- N-Nitrosodiisopropylamine (NDIPA)
- N-Nitrosodibutylamine (NDBA)
- N-Nitrosomethylphenylamine (NMPA)
- N-Nitrosomorpholine (NMOR)
- N-Nitrosopyrrolidine (NPYR)
- N-Nitrosopiperidine (NPIP)
Recently, regulatory agencies have also identified numerous Nitrosamine Drug Substance Related Impurities (NDSRIs) that are unique to specific pharmaceutical compounds.
Our LC-MS/MS nitrosamine testing services include the following:
- Detection and quantification of regulated nitrosamines
- Nitrosamine Drug Substance-Related Impurities (NDSRIs) analysis
- Testing of APIs and finished pharmaceutical products
- Method development and validation
- Stability study support
- Batch release and regulatory compliance testing
Why Choose Tamilnadu Test House?
- Advanced Triple Quadrupole LC-MS/MS technology
- High sensitivity for ultra-trace impurity detection
Experienced pharmaceutical analytical scientists - Fast turnaround time
- Regulatory-compliant analytical reports
- Reliable support for domestic and international pharmaceutical manufacturers
At Tamilnadu Test House, we are committed to delivering precise, dependable, and regulatory-compliant nitrosamine impurity analysis to help ensure the safety, quality, and compliance of pharmaceutical products.