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<p>This study presents a comprehensive, systematic evaluation of the stability of guaifenesin, a well-known expectorant drug, spanning an extraordinary real-time aging period of up to 72&#xa0;years. A unique collection of seventeen authentic historical pharmaceutical preparations, manufactured in the former Czechoslovakia and the Czech Republic between 1954 and 1997, was analyzed using an optimized RP-HPLC method coupled with UV and mass spectrometry detection. A forced degradation study was conducted to evaluate the hydrolytic and oxidative stability of guaifenesin under various stress conditions. Hydrolytic cleavage was not observed, whereas oxidative stress yielded significant decomposition. Using HR-MS/MS, the primary oxidative degradant was conclusively identified for the first time as 3-(2-hydroxyphenoxy)propane-1,2-diol. Quantitative analysis of historical samples revealed that the guaifenesin content closely matched the declared values in all solid and liquid formulations, demonstrating that this active pharmaceutical ingredient possesses an outstanding shelf-life. Remarkably, even liquid dosage forms manufactured 72&#xa0;years ago showed no significant signs of decomposition.</p> Graphical abstract <p></p>

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Guaifenesin stability: analysis of its 1954–1997 pharmaceutical products, forced degradation study, and identification of oxidative degradation product

  • 期刊论文

  • 发表日期：

    2026年8月3日

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  • Karel Nesměrák,
  • Alžběta Kimrová,
  • Tomáš Lener,
  • Ladislava Valášková,
  • Martin Štícha

摘要

This study presents a comprehensive, systematic evaluation of the stability of guaifenesin, a well-known expectorant drug, spanning an extraordinary real-time aging period of up to 72 years. A unique collection of seventeen authentic historical pharmaceutical preparations, manufactured in the former Czechoslovakia and the Czech Republic between 1954 and 1997, was analyzed using an optimized RP-HPLC method coupled with UV and mass spectrometry detection. A forced degradation study was conducted to evaluate the hydrolytic and oxidative stability of guaifenesin under various stress conditions. Hydrolytic cleavage was not observed, whereas oxidative stress yielded significant decomposition. Using HR-MS/MS, the primary oxidative degradant was conclusively identified for the first time as 3-(2-hydroxyphenoxy)propane-1,2-diol. Quantitative analysis of historical samples revealed that the guaifenesin content closely matched the declared values in all solid and liquid formulations, demonstrating that this active pharmaceutical ingredient possesses an outstanding shelf-life. Remarkably, even liquid dosage forms manufactured 72 years ago showed no significant signs of decomposition.

Graphical abstract