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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Sample Characterization using Thermogravimetric Analysis (TGA)
TGA is a useful technique for evaluating weight loss of materials as a function of temperature and time. Weight loss information is useful in characterization materials and problem solving. Impact Analytical has experience using TGA as a tool in solving problems including:
Copolymer or polymer blend characterization
Polymer Degradation, including under air, oxygen environment
Residual moisture determination
Residual solvent content
Inorganic salt or filler content
Sample matrices applicable for analysis include: