High-resolution semi-preparative recycling chromatography system for isolation and preparative of unknown trace impurities in pharmaceutical products

摘要

The present disclosure relates to a recycling chromatography method comprising injecting a sample into a mobile phase flow stream of a chromatography system to produce a composite flow stream. The sample contains API and at least one impurity. The chromatography system includes a first column and a continuous column, a first valve that communicates fluidly with the first and second chromatography columns, a heater that communicates with the first and second chromatography columns, a first and a first. It includes a fraction collector that communicates with the chromatography column of 2 and a second valve that is placed in front of the fraction collector. The composite flow stream is switched from the first chromatography column to the second chromatography column, and by switching the first valve, until baseline resolution is achieved and at least one impurity is separated from the API. On the contrary, it is recycled. The at least one impurity is recovered by the fraction collector.