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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Manufacturing support testing for the pharmaceutical industry.
Release testing is an important aspect of the pharmaceutical drug development and product process. It is critical that this testing be performed accurately, compliantly and quickly. Impact Analytical has a full breadth of analytical offerings to meet any release testing need. Our scientists understand the time sensitivity around developing methods for new drug products to efficiently and safely take them to market. Finally, our robust quality system will stand watch over the entire process to make certain all data provided is compliant with the appropriate regulations. Impact Analytical offers release testing in the following laboratories:
Liquid separations – HPLC, UPLC, LC-MS, Karl Fisher, GPC (SEC)
Gas separations – GC-FID, GC-TCD, GC-MS, Headspace GC, SPME
Molecular characterization – FT-IR, NMR, UV/Vis
Thermal analysis – DSC, TGA
Impact Analytical’s quality designations include: