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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Take Action. Problems-Solved.
Altered taste, odd odors, unknown package identification or new packaging development – Impact Analytical has your packaging problems solved.
Our state-of-the-art facilities contain the latest separation science instrumentation to address these needs, including two liquid chromatograph-mass spectrometers (LC-MS), three high performance liquid chromatographs (HPLC), three gas chromatograph-mass spectrometers (GC-MS) and three GCs coupled with flame ionization detection (FID) and thermal conductivity detection (TCD).
For packaging identification, we have the most advanced microscopy equipment available, including a scanning electron microscope (SEM), transmission electron microscope (TEM) and a fourier transform infrared spectrometer (FT-IR) microscope. These instruments can be teamed to characterize multi-layer packaging materials for layer thickness, morphology, and ID. However, the best equipment in the world is useless without an expert team of technicians or analysts who knows how to operate it. Our highly-trained staff is ready to provide dependable packaging solutions.