Impurity Isolation and Charaterization
Impurities may be found in a sample during a manufacturing process or a stability study for an Active Pharmaceutical Ingredient (API) or drug product. Impurities may arise as degradation products, as intermediates/process impurities originating from the synthetic route, as unwanted by-products of side reactions or as contamination of the original sample. It is important to isolate and identify impurities that may occur at very low concentrations relative to the API, perhaps as low as 0.05% w/w.
Our experienced scientists perform detailed characterization using a diverse range of technologies which include MALDI-MS, LC-MSMS, HPLC, IR, NMR and fluorescence methods.