Active Pharmaceutical Ingredients Qualitative Analysis by GC-MS

Active Pharmaceutical Ingredients (APIs) are the key components in pharmaceutical drugs responsible for producing the necessary effects to treat various medical conditions. Ensuring the quality, safety, and efficacy of APIs is critical for regulatory compliance with authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Consistency across pharmaceutical batches, detection and quantification of impurities, stability testing, and overall identification and quantification are essential aspects of API analysis.?

Given the rigorous analysis standards required by regulatory bodies, the use of advanced analytical techniques such as mass spectrometry is indispensable. While liquid chromatography-mass spectrometry (LC-MS) is typically preferred for API analysis, gas chromatography-mass spectrometry (GC-MS) has also proven to be a highly effective technique. This application note highlights the capabilities of the SCION 8500 GC, equipped with the 8400 PRO autosampler and the 8700 Single Quad MS (SQ-MS), in the rapid and reliable analysis of antihistamines.?

The SCION 8500 GC platform, along with the 8700 SQ-MS and 8400 PRO autosampler, offers a powerful solution for fast and efficient analysis. This system is equally compatible with the SCION 8300 GC model, providing flexibility in terms of instrument selection while maintaining analytical precision. In this application, we demonstrate the ability to analyse a range of antihistamines within a short time frame of just 7.13 minutes, showcasing the system’s efficiency in handling complex pharmaceutical compounds.?

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