Impurity Identification

  • What is Impurity Identification?

    Impurity identification is the process of elucidating the nature of unknown materials in pharmaceuticals, medical devices, combination products, 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 chemical 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.

  • woman purple pipet impurity identification
In any product, impurities can delay development or can cause a recall of a product on the market. Chemical impurity analysis is critical in medical device and pharmaceutical development because impurities can impact the safety and efficacy of final therapeutic products. Various organizations such as the FDA and ICH provide recommendations regarding testing for impurities and acceptable impurity limits in a medical device or pharmaceutical product. Regulations for pharmaceutical impurities include USP general chapter <1086> “Impurities in Drug Substances and Drug Products” and USP <476> “Organic Impurities in Drug Substances and Drug Products”. You can learn more about these chapters here. USP <232> and <233> provide guidelines for elemental impurities.

Impurity Identification Services at EKG Labs

EKG Labs provides impurity identification and impurity characterization services to the medical device, pharmaceutical product, 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 FDA and ICH guidelines for impurities. 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.

In some cases, chemical impurities develop when a device, pharmaceutical, or other product is stored for a long time. The formation of these degradants is impacted by temperature, humidity, light, and contact with other substances. At EKG Labs, we can help customers simulate a variety of these conditions during stability programs in order to develop an impurity profile through forced degradation. We can then monitor the formation of impurity degradants and help determine if the chemical degradation is a potential concern for the safety or efficacy of the product.

EKG Labs also provides problem solving services to identify the source of the impurity such as analyzing raw material 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 and analysis needs.

Product Expertise
Analytical Techniques for Impurity Identification
  • Chromatography– HPLC, LC/MS, 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
  • Learn more about our instrumentation here

EKG Labs has significant experience identifying impurities in drug products, as well as impurities in drug substances and excipients. Click here for an example EKG Labs case study on separating co-eluting impurities.

EKG Labs also has experience identifying medical device impurities. To read about EKG Labs’s work with adhesive impurities in medical devices, click here.