Clinical Release Testing
Release testing is an important aspect of the pharmaceutical drug development and product process. It is critical that this testing be performed accurately, compliantly and quickly. Impact Analytical has a full breadth of analytical offerings to meet any release testing need. Our scientists understand the time sensitivity around developing methods for new drug products to efficiently and safely take them to market.
Whether release testing encompasses an assay of an active ingredient and evaluation of impurities of a drug product, characterization of a medical device for compliance, or analysis of a manufactured product to confirm specification and acceptance, we have the experience to meet your testing needs.
Finally, our robust quality system will stand watch over the entire process to make certain all data provided is compliant with the appropriate regulations. Impact Analytical offers release testing in the following laboratories:
- Liquid separations – HPLC, UPLC, LC-MS, Karl Fisher, SEC/GPC
- Gas separations – GC-FID, GC-TCD, GC-MS, Headspace GC, SPME
- Molecular characterization – FT-IR, NMR, UV/Vis
- Thermal analysis – DSC, TGA