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.
Data Elements: OurServices.aspx
Fourier Transform Infrared Spectroscopy (FT-IR) spectroscopy is part of the molecular spectroscopy capabilities and is a popular tool used to determine the functional groups present in samples from the infrared absorbance spectra. The analysis is used to characterize products as well as unknown materials. The spectra can be used with a wide variety of material types from paints and coatings to pharmaceuticals and foods. Impact Analytical’s instrumentation has been qualified for use in compliance with: U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP) Regulations, 21 CFR Parts 210 and 211, and the United States Pharmacopeia (USP).
This type of instrument has the capacity to analyze a variety of sample types, such as solids, gels, liquids, or emulsions. The most popular analysis technique is a diamond attenuated total reflection (ATR) accessory, which can be used for every sample type, and requires little sample preparation. Samples can also be analyzed in KBr pellets, mull cells, and liquid cells. The FT-IR analysis can be used for qualitative and/or quantitative analysis of materials. A wide variety of electronic reference libraries are available to assist in the identification of unknown materials and/or confirm the chemical composition of a material.
- Because IR absorption is dependent upon a dipole moment change during each molecular vibration and/or molecular rotation, chemical functional group analysis, as well as molecular characterization and identification, is possible. Researchers involved in synthesis use this 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.