What is Impurity Identification?
Impurity identification is the process of elucidating the nature of unknown materials in combination products, medical devices, pharmaceuticals or consumer products using a variety of analytical techniques. Three groups of impurities typically evaluated during impurity identification are organic impurities, inorganic impurities and residual solvents. Sources of these impurities can come from the manufacturing process and/or storage of material. Examples of impurities include: starting raw materials, by products, intermediates, degradants, reagents, ligands, catalysts, heavy metals, residual metals or any other materials or process aids in the production process. In any product, impurities can delay development or can cause a product on the market to be recalled. Impurity identification is critical in medical device and pharmaceutical development because impurities can impact the safety and efficacy of a final therapeutic product. Various organization such as the FDA and ICH provide recommendations regarding testing for impurities and how much impurity is acceptable in a medical device or pharmaceutical product.
Impurity Identification Services at EKG Labs
EKG Labs provides impurity identification services to the medical device, pharmaceutical and consumer product industries. We have the analytical instrumentation and experience to isolate, analyze and identify impurities. EKG Labs can perform impurity identification in accordance with ICH and FDA guidance. Once an impurity is identified, EKG Labs has the ability to have a reference standard prepared and characterized. We can also develop and validate a method in order to monitor the impurity. EKG Labs also provides problem solving services to identify the source of the impurity such as analyzing material from raw material suppliers or investigating various aspects of the manufacturing process itself. At EKG Labs we work with you to provide a customized solution to your impurity identification needs.
- Combination Medical Devices
- Medical Device
- Pharmaceutical Products (API, Drug Substance, Drug Product etc.)
- OTC Pharmaceuticals
- Consumer Products
Analytical Techniques for Impurity Identification
- ICH Guidelines for Impurity Identification
- Chromatography– HPLC, LC/MS, GC, GC/MS, GC/FID, GC/TCD, GPC/SEC
- Spectroscopy – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
- Microscopy – SEM, TEM, AFM, STM, LSCM
- Other- TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer