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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Determination of water content by Karl Fischer analysis
Impact Analytical provides Karl Fischer (KF) titration services to determine water and moisture content in both liquid and solid materials. Our laboratory is equipped with both volumetric and coulometric titrators, as well as an oven attachment for analysis of solids. Volumetric KF can determine water in the 0.1-100% range, while coulometric KF is used for lower water concentrations in the 0.001-0.1% range.
Examples of Karl Fischer applications:
- Determine water content when performing VOC testing (e.g. EPA 24)
- Water content determination for material MSDS
- Moisture content in support of USP purity assays (e.g. raw materials and active ingredients)
- Water content determination in food and beverages (e.g. milk, spirits), and consumers products (e.g. laundry detergents, sunscreens)