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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Isolation, identification, and/or quantitation of active ingredients
Impact Analytical provides comprehensive active ingredient and active pharmaceutical ingredient (API) testing for identification and quantitation.
Active quantitation can be performed on various products including pharmaceuticals and consumer products. Understanding the amount of active in your finished product can be crucial to its safety, especially in the pharmaceutical industry. We can develop customer methods or work from an existing method. Method validation is available as well.
Products we commonly work with for actives quantitation testing include:
- Pharmaceutical products
- Household cleaners
- Formulated products