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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Characterization of volatile organic compound (VOC) levels.
Products manufactured with or containing volatile components have potential safety, environmental and toxicity concerns. It is important to accurately characterize the VOC levels in these products in accordance with federal, state and industry standards. These standards can vary widely depending on the product and application, and it is important that your testing laboratory be versed in the various testing methods and requirements.
Impact Analytical has a combination of expert scientists and state-of-the-art instrumentation to produce the most accurate and timely results in the industry. A few examples of VOC methods that Impact Analytical tests against are:
VOCs in pesticides by TGA, according to California VOC Method
GMW 8081 for VOCs in automotive dashboard components
EPA Method 24
PATAC TS-INT-002 for VOCs in automotive dashboard components
Headspace GC-MS for testing of identification of VOCs in consumer products