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, dissolution, 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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Move Forward With Confidence.
We certainly understand the confidentiality that goes along with this industry. Whether you are looking to deformulate a competitor's sample or requiring data to support a patent infringement lawsuit, you can be confident that we will keep all information confidential and handle your project professionally.
Our scientists have analyzed a wide range of sample types including:
All Purpose Cleaners
Product Raw Materials
We have analyzed these samples to provide compositional information (deformulation, reverse engineering), thermal/mechanical property measurement and contaminant identification. All analyses are collected by highly trained scientists on state-of-the-art equipment. Techniques typically utilized include NMR, FT-IR, LC-MS, GC-MS, as well as other analytical techniques.