Whitepaper: Supelco preparative HPLC products for pharmaceutical development and production
There is an increasing need for purified materials in the development and production of pharmaceutical products. FDA and other regulatory agencies continue to require more stringent purity requirements on active pharmaceutical ingredients (API), including most recently chiral purity.
Studies are often executed concurrently with impurities, degradants, and metabolites to determine if their potency or toxicity is a concern for the API in development. As the demand for purification increases, tools beyond classic crystallization are often needed. Some choices include filtration, distillation, solid phase extraction, thin-layer chromatography (TLC), low-pressure liquid chromatography (LPLC), and high-performance liquid chromatography (HPLC). In many instances,
preparative HPLC is the most powerful and versatile method for the challenging purification tasks in the pharmaceutical industry.
Stationary Phase Selection
The first important criterion for preparative chromatography is that the proper stationary phase is selected. A consideration beyond phase applicability is the commercial availability in both analytical and preparative dimensions as well as bulk packing material.