Application Handbook, Chromatography Solutions For API Manufacturers

This application handbook details solutions for Active Pharmaceutical Ingredient (API) manufacturers, covering crucial analytical challenges from sample preparation to residual solvent and impurity analysis.

Effective sample preparation is achieved with Phenex syringe filters, a reliable filtration product designed to remove particulates before injection. Using high-quality filters protects chromatography columns and instrumentation from damage while avoiding ghost peaks and false quantitation caused by low-quality alternatives.

For High-Performance Liquid Chromatography (HPLC), the brochure highlights Luna Omega fully porous silica columns and Kinetex Core-Shell technology. These columns offer high efficiency and resolution for separating complex mixtures of drug substances and impurities. Gas Chromatography (GC) methods for analyzing residual solvents, as per USP chapter 467, feature high-performing Zebron GC columns. Additionally, the resource presents LC-MS quantitation workflows for analyzing carcinogenic nitrosamine impurities and their related substances.

Unlock method development insights and purification strategies across multiple chromatography platforms. Access the full application handbook today.