Abstract
Water content of active pharmaceutical ingredients (APIs) and excipients directly impacts their quality. The accurate determination of water is therefore critical and has been designated as a specific test by leading pharmacopeias. Loss on drying (LOD) and Karl Fischer Titration (KFT) are the primary methods described. The former is the loss of weight (usually at 105 °C for a given period) expressed as a percent (w/w) of the mass of sample. The latter is the most widely used analytical technique for water determination. However it is still subject to interferences, requires larger sample sizes, and the sample is destroyed. Gas chromatographic (GC) methods are versatile, rapid and accurate techniques, which only require small amounts of sample. Polar stationary phases are required to afford reasonable peak shapes. Near-infrared spectroscopy (NIRS), although not a primary method, is a rapid, noninvasive, nondestructive analytical technique that is particularly sensitive for water.
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