Trace-level analytic for N-nitrosamines
Testing for N-nitrosamines is a hot topic in the pharmaceutical industry since 2018 when these potential carcinogens were found first in sartans and later on in ranitidine and some slow-release metformins. Manufacturing requirements have now become more stringent and demands on chromatography and mass spectrometry methods that meet regulatory requirements are increasing. Detection and quantification of these trace nitrosamines in APIs and drug products can be challenging and necessitates the use of advanced and sensitive tools to meet regulatory requirements.
GBA Pharma Labs offers highly sensitive Orbitrap-based mass spectrometry capable of selectively determining analytes at low concentrations with high confidence. Data acquisition and processing are carried out with a cGMP qualified Chromeleon CDS software with audit trails to assure data integrity and protection.
Our approaches meet and exceed FDA’s established regulatory requirements to help pharmaceutical customers to identify and quantify trace (ppb) nitrosamine in customized systems optimized for the respective sample matrix.
Besides a targeted screening of nine common Nitrosamines (Figure 1), GBA Pharma Labs offers full scan measurement of samples including MS/MS experiments in APCI+ mode allowing untargeted screening followed by data processing using Compound Discoverer software and database queries to cover for other nitrosamines present in the samples.
Compared to other currently available methods, the untargeted screening approach offers a higher safety level and is another unique selling point of the Orbitrap-based method. GBA Pharma Labs will be pleased to provide you with further advantages and details of the method in a personal talk.