Water content affects the shelf life, stability and reactivity of active pharmaceutical ingredients (API). Conventional methods like Karl Fischer titration are considered reliable providing the conditions, such as ambient moisture and water content in the solvent, are controlled. However, Karl Fischer titration is time consuming and labor intensive method while utilizing toxic reagents and can yield inaccurate results if moisture is not controlled. Utilizing the characteristics of a novel ionic liquid as a solvent a constant low water content background can be achieved. The low background allows for 4 milligram samples and detection of trace water content.  In this paper we will show that ionic liquids allow headspace gas chromatography to be used as an accurate high throughput method for detection of water in pharmaceutical compounds.

Water detection in active pharmaceutical ingredients using headspace gas chromatography

247th National Meeting (2014)

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