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- W1999462745 abstract "Recent advances in bonding chemistry and novel silica synthesis have significantly extended the pH range of silica-based HPLC columns. This extended range now enables the analysis of water-soluble basic drugs at high pH without ion-pairing reagents, thus offering an alternative approach to assay or impurity analyses. This paper describes the many advantages and potential pitfalls of using high-pH mobile phases in the development of MS-friendly LC gradient impurity analytical methods for water-soluble basic drugs under International Conference on Harmonization (ICH) guidelines. Operating at high-pH provides excellent peak shapes and retention, and accentuates selectivity differences of structurally similar impurities and degradants. However, several problems unique to the use of high-pH mobile phases, such as column lifetime, robustness of pH adjustments, peak fronting, and on-column dimerization, were encountered. Each of these problems is discussed with its respective remedy." @default.
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- W1999462745 date "2003-02-01" @default.
- W1999462745 modified "2023-10-16" @default.
- W1999462745 title "Mass spectrometry-compatible ICH (International Conference on Harmonization) impurity analysis with a high-pH mobile phase" @default.
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- W1999462745 doi "https://doi.org/10.1016/s0021-9673(02)01961-1" @default.
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