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 and identification of unknown components and impurities.
Depending on the product application, the presence of an unknown component or impurity at even trace levels can cause irreparable damage to a product, rendering it unusable. Unknown components and impurities can appear from several sources and, once present, can be extremely difficult to remove. Impact Analytical’s full breadth of analytical capabilities and 30+ years of experience characterizing unknowns and impurities enable us to solve these tough problems. We have proven methodologies for specific material types that allow us to efficiently isolate and identify the material, followed by determining its source.
Unknown and impure materials can come from numerous sources, including:
API and/or non-active component degradation
Oxidated polymer additives
Extractables / leachables