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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Fourier Transform Infrared Spectroscopy (FT-IR) is a popular tool for determining unknown identification and functional group presence in chemical systems.
Sampling formats include: KBr pellet, mull cells, and liquid cells, all of which can be run at variable controlled temperature. Diamond ATR accessory is also available.
- Because IR absorption is dependent upon a dipole moment change during each molecular vibration and/or molecular rotation, functional group analysis as well as molecular characterization and identification is possible. Researchers involved in synthesis use the instrument frequently to determine if desired functional groups are present in compounds they have synthesized.
- The system includes a polymers and additives library. A customer desiring identification of a polymer used to mold a finished product submitted a sample for unknown identification. A small amount of the polymer was excised from the article and dissolved in a solvent. A thin film of the polymer was cast and its infrared spectrum was measured. By searching the library, a match was found for the spectrum thereby identifying the material.
Problem: Unknown white residue was contaminating the surface of black molded plastic parts?
Solution: Contaminant ID - read full case study
Industry: Food Packaging
Problem: Manufacturer of multi-layer films for the food packaging industry needed to measure the thickness of layers for quality control. Customer also desired measurement and identification of the layers used to construct competitor's products.
Solution: Impact used a combination of polarized light microscopy and infra red microscopy to photograph, measure, and identify the separate layers of the film in cross section.
Problem: Unknown residue appeared on the surface of an extruded plastic car window jamb after environmental testing at one facility, but not at another.
Solution: Removed residue from the surface of the window jamb and analyzed with FT-IR spectroscopy. Analysis determined the material to be an oil (or oleamide), a material often used as a slip agent in the molding process. Oil was also found in the resin of one of the plastics used in the window jamb. Gas Chromatography-Mass spectrometry (GC-MS) confirmed that the oil found on the surface of the part and the resin was the same, and enabled the customer to decide whether to change the resin used or change the conditions of environmental testing.