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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Quantitation of Reproductive Toxins including Bisphenol A (BPA) and Diethylhexyl Phthalate (DEHP) in Polymer Materials
BPA is a monomer used in the production of polycarbonate plastic materials, which are subsequently used for the manufacture of consumer products such as water bottles, baby bottles, dental fillings, syringes and food containers. DEHP is a plasticizer added to polyvinyl chloride materials in medical devices such as tubing, catheters and dialysis bags. These two compounds have been found to be reproductive toxins in animals and humans, and therefore control of the concentration of these components in materials used as medical devices or food and water storage is important. DEHP concentration is regulated by the US to be below 6 parts-per-billion (ppb), and BPA (no regulations at this time) has been found to cause adverse reproductive affects at concentrations as low as 0.5 ppb.
Impact Analytical has developed exhaustive extraction procedures that allow for the accurate quantitation of these two compounds. These procedures are applicable to all types of consumer products possibly containing BPA, as well as Class II, III and IV medical devices required by Health Canada to be tested for DEHP. Testing can also be performed to allow conformance to EU REACH regulations.
California's Prop 65
California’s Office of Environmental Health Hazard Assessment (OEHHA) has added Bisphenol A (BPA) to the Proposition 65 list of chemicals known to the state to cause reproductive toxicity. The Developmental and Reproductive Toxicant Identification Committee (DARTIC), which serves as the “state’s qualified experts,” assessed BPA at a public meeting held on May 7, 2015. DARTIC concluded that BPA, through scientifically valid testing, caused reproductive toxicity.