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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Material Characterization for Residual Solvents
Organic solvents are used in manufacturing processes of products in all industries. Many of these solvents are harmful, and can be present in the final product as residuals from the manufacturing process. It is important, and in some industries required, that residual solvent levels are monitored in the final product. Impact Analytical has the tools and experience to characterize products from all industries for residual solvents. Our experts can develop product specific methods, or utilize regulatory methods to identify and quantitate residual solvents to the lowest levels possible.
Examples of past projects include:
- Quantitation of Residual Solvents in Medical Tubing
- Quantitation of Residual Solvents using USP method <467>
- Modification of USP <467> for use with water insoluble medical device