Impurity Profiling

Impurity Profiling requires a broad array of advanced analytical instrumentation to identify, characterize, and quantify the presence of impurities in an Active Pharmaceutical Ingredient (API) or finished drug product. Pharmaceutical impurity testing and quantification is essential to ensure the purity, safety, and quality of APIs, excipients, other drug substances and finished drug products. Some of these impurities may be present at extremely low levels and are often in complex matrices. Their detection requires highly sensitive and specific methods of detection.

Mass Spectrometry (MS) is an extremely sensitive technique which is often used as a detector for High Performance Liquid Chromatography (LC-MS) or Gas Chromatography (GC-MS). LC-MS and GC-MS can achieve simultaneous separation and identification of minor and trace impurities in complex mixtures. Regulatory agencies have set low thresholds of tolerance due to the health risks associated with nitrosamines, extractables & leachables, per- and polyfluoroalkyl substances (PFAS), pesticides, and other impurities. HPLC combined with triple quadrupole mass spectrometers (LC-MS/MS) provide high sensitivity to sub-parts per billion (ppb) levels required for the testing of some of these impurities. In addition, the identification and quantitation of elemental impurities and heavy metals are achieved using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) which provides sensitive and definitive analysis for elemental analysis.

Scientech Laboratories has a dedicated Mass Spectrometry Lab for MS analyses with state-of-the-art LC-MS, GC-MS, LC-MS/MS, and ICP-MS instrumentation. We have analytical chemistry expertise and methods developed to assist with your impurity profiling needs including nitrosamines, extractables & leachables, API impurities, heavy metals, PFAS, pesticides, residual solvents, and much more.