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, dissolution, 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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Determination of Molecular Weight
Molecular weight is critical property of a chemical, particularly for polymers. Impact Analytical has extensive experience and comprehensive tools for measuring molecular weight of all types of compounds and polymers. We can supply results to aid in problem solving, unknown identification, manufacturing support, or product deformulation. Techniques available for characterizing molecular weight include: