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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Characterization of Volatiles using Headspace GC-MS
Impact Analytical's gas separation laboratory is equipped with Headspace GC-MS analyzers – an ideal technique for characterizing volatile materials in a sample or material. Headspace GC-MS is a method of choice for residual solvents, volatile organic compounds (VOC’s), and taste and odor problem solving.
Headspace GC-MS analysis services we routinely provide include:
- Headspace GC-MS Analysis for Residual Solvents per USP <467>
- Residuals Analysis by Headspace GC-MS
- Headspace Analysis to Determine Off-Odors
- Quantitation of Free Volatiles
- Volatile Organic Compound (VOC) Testing by Headspace