Extractables and Leachables Analysis Solutions

Elemental impurities in pharmaceutical formulations can impact drug efficacy and patient safety. Guidelines like ICH Q3D, USP <232>, and USP <233> require monitoring of metal impurities using advanced techniques such as ICP, ICP-OES, and ICP-MS. Thermo Fisher Scientific provides precise solutions to help ensure compliance and safeguard product quality.

Identifying and analyzing solvents and volatiles in pharmaceuticals is crucial, as they can impact drug efficacy and patient safety. Thermo Fisher Scientific offers proven, compliant workflows for organic volatile impurities, following regulatory guidelines like USP <467> and ICH Q3C for residual solvents, helping to ensure product safety and regulatory compliance.

Semi-volatile organic pharmaceutical impurities require high selectivity and sensitivity for accurate analysis. Thermo Fisher Scientific’s Orbitrap-based mass spectrometry provides exceptional performance for identification and quantification, utilizing advanced filtering algorithms and automated library searching. This powerful workflow ensures unambiguous impurity identification across APIs, intermediates, excipients, and extractables and leachables, delivering reliable results with high confidence.

Impurity profiling is a key quality control process in pharmaceuticals and biopharmaceuticals, regulated by ICH and the US FDA. Following ICH guidelines, impurities are analyzed for physicochemical properties and safety using techniques like HPLC, mass spectrometry (MS), and nuclear magnetic resonance (NMR). These methods ensure accurate impurity identification and regulatory compliance, which help support drug safety.​

Per- and polyfluoroalkyl substances (PFAS) are toxic, persistent chemicals now regulated in drinking water but not yet in pharmaceuticals, posing hidden safety risks. Our PFAS testing solution uses a single LC-MS injection for both targeted quantitation and non-targeted screening, detecting known compounds at sub-ppb levels and uncovering unknowns. A PFAS-specific kit and delay column reduce background interference for more reliable results. Integrated with Thermo Scientific Chromeleon Chromatography Data System (CDS), the workflow is streamlined and 21 CFR Part 11-compliant—helping manufacturers stay compliant and avoid costly setbacks.