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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Ultra-Performance Liquid Chromatography
Impact Analytical offers Ultra-Performance Liquid Chromatography (UPLC) testing services which is the newest technology in liquid chromatography. UPLC involves the liquid chromatography at high pressures, providing chromatography that outperforms traditional HPLC in peak resolution. In addition, UPLC delivers separations in 3-10 minutes, as compared to 15-20 minute separations in traditional HPLC. Please see below for an overlay of characterization of a standard of polymer additives by UPLC and traditional HPLC.
Traditional HPLC Chromatogram
These improvements are accomplished through re-engineered columns that utilize sub-2-µm particles which can handle increased pressures from innovative LC pumps and injectors. Impact Analytical has added a Waters Acquity UPLC to our stable of capabilities, and is leading the migration from HPLC to UPLC. Contact us to discuss how UPLC can simultaneously improve the quality and speed of your separation. We currently offer analysis utilizing UPLC for the following needs:
The Case for Upgrading Existing HPLC Assays to UPLC
November 29, 2011
By: Eric Hill