Chiral HPLC method development services are provided at all stages of the drug development supporting manufacturing and chiral resolution processes. AMRI provides a comprehensive HPLC screening of chiral stationary phases from diverse manufacturers to ensure appropriate selectivity and quantitation limit is achieved. Screening performed on normal and reverse-phase, polar organic and polar ionic modes are conducted providing a mobile phase array that covers a wide range of polarities. Mobile phase additives are often used based on the structural features of the target. AMRI also offers chiral SFC method development as a complement to chiral HPLC, mostly focusing on applications for preparative resolution processes (link to chiral resolution).
Qualification of chiral chromatographic methods is routinely performed at AMRI based on ICH guidelines. The chiral method could be used for the quantitative or qualitative determination of chiral and diastereomeric purity of drug substances, drug products, intermediates and raw materials, and for monitoring resolution processes.