Elemental Impurities Testing

Our elemental impurities experts and toxicologists can help you to develop a compliance strategy to achieve successful implementation of ICH Q3D requirements. Intertek's GMP laboratory services teams facilitate the process through the design of tailored analytical programs based on wide experience of pharmaceutical impurity analysis and in-depth knowledge of elemental impurity testing and the ICH Q3D guideline, along with years of experience in conducting toxicological risk assessments. We can provide screening studies and data to aid risk assessment, if this does not already exist, or develop and validate methods tailored to the clients’ specific products.

Our laboratories utilise inductively coupled–optical emission spectroscopy (ICP-OES) and inductively coupled–mass spectrometry (ICP-MS) to perform elemental impurity testing in accordance with pharmacopoeial procedures (such as USP General Chapter <232> and Chapter <233>), or suitable alternative procedures. Our scientists are skilled in the selection of method preparation (including microwave digestions) and instrumentation based on your products sample matrix and the required limit of quantitation (LOQ). Our toxicologists evaluate the generated data and perform toxicological assessments to help you understand the potential risks to patients due to exposure to elemental impurities in your drug products, derive relevant PDE values for the impurities (where necessary), and prepare written reports that can be submitted to regulatory authorities as needed.