Study on the methods of the moisture content determination of active pharmaceutical ingredients recommended by the British pharmacopoeia
Abstract
The weight of water contained in an object or material is referred to as moisture content (or
water content). The karl fischer titration, azeotropic distillation, and the loss on drying
method are the three basic methods for determining the moisture content of pharmaceutical
compounds. Karl Fischer titration is a classic titration method in chemical analysis that
determines tiny amounts of water in a sample using coulometric or volumetric titration.
Azeotropic distillation is the technique of using distillation to separate the components of an
azeotropic mixture. Loss on drying is a common test method for determining a sample's
moisture content, although it can also define as the loss of any volatile matter from the
sample. For the determination of water, the maximum of the APIs follow after the loss on
drying method.