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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Identification and Quantitation of Antioxidant Packages in Polymer Materials
Antioxidant components are added to polymers to absorb oxidation, and shield the polymer material from degradation. Degradation can include weathering, brittleness, and yellowing. These antioxidant packages can vary depending on the manufacturer, molder, application or identity of the polymer material. Common antioxidants include:
Impact Analytical has 40+ years of experience characterizing polymer materials, including antioxidants. We have methods developed for specific polymer materials, including polyolefins (polypropylene, polyethylene), PVC, Polyesters, Polyamines, Polyols, Polyurethanes and others. These methods efficiently extract the polymer additives from the material, allowing for accurate identification and quantitation.