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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Characterization of Polymeric Materials
Impact Analytical specializes in polymer material characterization. We grew out of the Michigan Molecular Institute (MMI), a world-renowned polymer research facility with over 50 years of polymer experience. Impact Analytical supported polymer research at MMI and now applies this experience to customer testing needs. Our experience includes characterizing polymers of all types and classes. We have developed specific methods for extraction and characterization of common polymer types. We also have in house mass spectral libraries compiled of 200+ spectra of polymer additives and degradation compounds. Some of our polymer testing services include:
We have experience working with all polymer types, including: