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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Material Characterization for identification, purity, properties or impurities.
Impact Analytical has a full complement of testing capabilities to characterize materials of all classes for identification, purity, properties, impurities and more. Our molecular characterization laboratory has experience analyzing polymers, solvents, small molecules, pharmaceuticals, impurities, unknowns and additives to identify molecular structure and molecular weight. Our microscopy and thermal/mechanical analysis laboratories can provide analysis to give thermal properties, mechanical properties or material morphology. Finally, our separations laboratories can provide purity information, as well as quantitate impurities, actives or additives. These analyses can be performed on the following material types: