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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Are you RoHS Compliant for 2017?
In an effort to reduce the use of, and subsequently the disposal of certain hazardous materials in medical devices, electrical and electronic equipment, the European Commission enacted Directive 2002/95/EC, also known as Restriction of Hazardous Substances (RoHS). This directive specified six restricted materials and maximum levels allowed for each. These materials are listed below:
- Lead (Pb): < 1000 ppm
- Mercury (Hg): < 100 ppm
- Cadmium (Cd): < 100 ppm
- Hexavalent Chromium: (Cr VI) < 1000 ppm
- Polybrominated Biphenyls (PBB): < 1000 ppm
- Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
Beginning in 2017, four additional materials, all of them phthalates, will be included on the list of restricted materials allowed for use in electrical and electronic equipment, as well as medical devices. These phthalates and the maximum allowable levels for each are listed below.
- Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
- Benzyl butyl phthalate (BBP): < 1000 ppm
- Dibutyl phthalate (DBP): < 1000 ppm
- Diisobutyl phthalate (DIBP): < 1000 ppm
Let Impact Analytical evaluate your polymer materials for RoHS compliance. With our expertise in polymers and polymer additives, we can determine if your product meets the new standard.