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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Optical microscopy using polarized light, when equipped with a hot stage, is a valuable tool for measuring phase transitions and crystallization kinetics. The polarizing light microscope at Impact Analytical is equipped with a hot stage, 35 mm camera, and intervalometer. The system is capable of taking a time series of photographs while holding the sample at a constant temperature. Measurements of crystal size taken from the series of micrographs enable growth rates of polymer crystals to be studied.
The hot stage can also be used to increase or decrease the specimen temperature at selected rates. Visual observations of specimen transitions and the temperatures at which they occur may be recorded.