Isolation and purification of impurity by preparative Chromatography (HPLC)
Impurities can arise at very low concentrations relative to the API during manufacturing process or a stability study for an Active Pharmaceutical Ingredient (API) or drug product, impurities might occur as degradation products, as intermediates/process impurities originating from the synthetic route, as an unwanted by-product of side-reactions or due to contamination of the original sample are isolated by preparative Chromatography (HPLC) at Olympus.
- % or concentration of impurity relative to the API
- Analytical Method with representative chromatogram
- Preparative method if available
- Depends on the impurity content
- For product-related impurities in the low percentage area, 200 mg sample are typically sufficient to obtain ≥ 1 mg of the enriched impurity