Isolation of impurities

Isolation of impurities

Sometimes an impurity has to be isolated to carry out some studies requiring the availability of the pure chemical compound:

• When additional structural analysis are required to confirm a hypothesized chemical structure of an unidentified impurity, such as NMR, GC-MS, or FTIR.

• A standard of the impurity required for QC analytical methods for impurity monitoring after drug manufacturing.

• Or when a new impurity must be biologically qualified because it is present at concentrations reaching 0.15% in the drug substance or pharmaceutical product.

Automated Preparative Liquid Chromatography allows the chromatographic fractionation to isolate the impurity in sufficient quantities reaching high purity values.

This site is registered on wpml.org as a development site.