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
Characterization of Volatile and Semi-volatile Materials by Gas Chromatography - Mass Spectrometry (GC-MS)
Impact Analytical offers GC-MS testing services to separate, characterize, identify, and quantitate volatile and semi-volatile components in various sample matrices. Our state-of-the-art GC-MS capabilities allow for detection of analytes to trace levels (sub part-per-billion). We utilize both purchased (NIST) and in-house spectral databases to identify unknowns. We also have chemical-ionization capabilities for identification of unknowns that are do not exist in our databases. Our equipment is qualified for testing under cGMP or GLP (FDA, EPA) guidelines if needed. A summary of services that we offer utilizing GC-MS is included below:
Industry: Medical Device
Problem: Residual Solvents per USP method <467>
Solution: Modified <467> - read full case study
Industry: Consumer Products & Plastics
Problem: Consumer product supplier needed to determine if Bisphenol-A (BPA) was present in their final products: polymer containers, lids, and storage bags.
Solution: BPA Testing - read full case study
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.