ABSTRACT
THEORY AND APPLICATION Distillation is the primary process used for the production of USP Water for Injection for pharmaceutical applications. It is the only process allowed for the production of EP Water for Injection. USP essentially states that Water for Injection may be produced by distillation or any process that can be demonstrated, on a consistent basis, to provide water equal or superior to distillation. However, the number of facilities employing membrane or other processes for the production of USP Water for Injection is extremely small. While USP, EP, and JP have attempted to “harmonize” the method for production of Water for Injection, it is strongly suggested that the EP (as well as certain other pharmacopeias) will require distillation for production of Water for Injection. The EP position regarding this matter refers to the “robust” nature of the distillation process specifically as it relates to the phase change of water to steam. Papers and presentations have addressed this issue (Meltzer et al., 2009; Collentro, 2005; and European Medicines Agency, 2008).
