Stable and Reliable Preparative Columns: New Approaches in Column Design

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Fang Xia, Jie Y. Cavanaugh, Darcy Shave, Gary Izzo, Michael Savaria, Thomas Grady, Markus Wanninger, Donald Ziniti, Brad Francis, Raymond Fisk, Joe Belanger, Damian Morrison, Diane M. Diehl [Waters]
AAPS, Salt Lake City Utah, October 26-30
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Content Subtype:
Econazole; Imipramine; Ketoprofen; Miconazole; Sulfathiazole;Tylosin
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In today’s drug purification environment, the demand for timely high purity results places huge emphasis on the integrity and stability of the preparative column. Complex sample starting materials demand high efficiency columns containing smaller particles (< 10 mm) than was conventionally used for purification. The challenge for the column manufacturer is to reproducibly produce analytical columns in preparative dimensions. We have developed an innovative procedure for the manufacture of preparative columns. A proprietary new procedure was developed for the manufacture of preparative columns with inner diameters of 19, 30 and 50 mm, and lengths from 30 to 250 mm. These columns were packed with a variety of stationary phases, and the stability, reproducibility and efficiencies were measured. Additionally, these new columns were tested by clients in the pharmaceutical industry to investigate their performance under actual use conditions. These results were compared to columns manufactured using older methodologies. The new procedure results in columns with dramatically improved column stability as compared to the older methodology. Because the bed densities of these columns more closely match those of analytical results, the chromatography is nearly identical to that obtained on an analytical column, making scale-up a much easier process. Preparative chromatography columns developed with a new innovative procedure deliver greater peak efficiency, column stability and lifetime while maintaining the integrity of a separation developed on an analytical dimension.

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