Research and Development Support
Testing support for product research and development.
Impact Analytical provides analytical testing to support drug product and medical device research and development. Impact’s scientists have a combined 300+ years of experience in analytical chemistry. We have experience developing material specific assays and methods for use in research support that can subsequently be utilized for final product testing. Our dedicated R&D support teams partner directly with the client to provide chemical and material testing support that ensures timeline integrity. This approach allows the client to access our experience and regulatory knowledge directly, saving time and budget.
Impact Analytical provides focused support for API development, assay and impurities methods development, container closure material selection, stability, drug or material compatibility, extractables, accelerated stability, and medical device material selection. This support can be leveraged from development through preclinical, phases I and II, and final product manufacture.
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Analysis by Liquid Chromatography-Mass Spectrometry
Impact Analytical has multiple LC-MS systems for the analysis of semi- and nonvolatile materials in various matrices. These systems include exact mass Q-TOF and ion trap systems. We offer identification and quantitative analyses. Our in-house databases have hundreds of compounds including polymer extractables, pharmaceutical impurities, surfactants, degradation products, and color bodies. We offer electrospray (ESI) and atmospheric chemical ionization (APCI) modes, in both positive and negative. All equipment is qualified for testing under cGMP and GLP (FDA, EPA) guidelines if needed. Examples of services utilizing LC-MS include: