Investigation to find a suitable reference material for use as an inverse gas chromatography system suitability test

International Journal of Pharmaceutics
J StapleyD Merrifield

Abstract

The purpose of this study was to find a suitable material for use as a system suitability test material for inverse gas chromatography (IGC). The purpose of a system check is to measure the variability of the instrument being used rather than the material being analysed. Having such a system check for IGC enables a basic GMP requirement to be met. IGC results can then be used in regulatory submissions to support other already established techniques for characterising pharmaceutical materials. Alpha-alumina was chosen because it is inorganic, stable at high temperatures, resistant to hydration and is already established as a system check material for surface area determination by nitrogen adsorption. Two columns (1 and 2) packed from the same reference sample jar of alpha-alumina and analysed under the same conditions yielded dispersive surface energies of 34.8+/-0.8 and 35.3+/-0.8 mJ/m(2), respectively, at 15% RH. Column 1 was analysed on a second IGC system, and gave a dispersive surface energy of 34.7+/-0.2 mJ/m(2). No significant change was evident after 7 months storage under laboratory ambient conditions. Analysis of material from a second reference sample jar of alpha-alumina produced results not noticeably different to t...Continue Reading

References

Dec 14, 1999·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·N M AhfatM D Ticehurst
Sep 14, 2000·Journal of Colloid and Interface Science·F Thielmann, E Baumgarten
Oct 19, 2002·Journal of Chromatography. a·Chenhang Sun, John C Berg

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Citations

Aug 6, 2014·Advances in Colloid and Interface Science·S Mohammadi-Jam, K E Waters
Jun 1, 2018·Water Science and Technology : a Journal of the International Association on Water Pollution Research·Ceyda Bilgiç
May 22, 2007·Analytical Chemistry·R K Gilpin, C S Gilpin

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