Foreign particulate analysis can identify contaminants present in your drug product. It’s the first step to improving overall product quality and drug safety.
Whether confirming the presence of particulates identified during visual inspection or responding to an FDA inquiry, foreign particulate analysis is the first step to resolving contamination issues in the pharmaceutical industry. After identifying foreign materials in your pharmaceutical product, it’s important to understand their composition and determine the potential impact on safety and quality and their ultimate source.
We use a multi-tiered analytical approach when conducting foreign particulate testing, which generally involves two key steps: identification and analysis. Our experts select the appropriate techniques for sample preparation and testing so that we can provide a comprehensive and informative identification. In general, microscopy is used to understand properties and appearance, FTIR and/or Raman spectroscopy is used to obtain a molecular fingerprint of the material in question, and SEM-EDS is used to obtain elemental information to help determine source.
Plus, our state-of-the-art facility is uniquely equipped to handle and analyze cytotoxic drug compounds. Contact us today to discover how Gateway Analytical can help your team reach its goals.