ABSTRACT
Water used in the manufacture of parenteral products is typically the most challenging of all pharmaceutical water applications since parenterals, by their nature, are uniquely able to access body fluids and tissues. Water, in this application, is especially well suited to serve in a multitude of roles associated with drug development, testing, manufacture, and delivery. This chapter discusses the uniqueness of parenteral water applications including the most regulatory requirements. There are a considerable number of water grades defined for global pharmaceutical applications with varying specifications and regulatory requirements. Packaged grades of water, including Bacteriostatic Water for Injection, Sterile Water for Inhalation, Sterile Water for Injection, Sterile Water for Irrigation, and Sterile Purified Water, are all sterile packaged waters typically produced from their bulk counterpart with further processing to meet the requisite monographic requirements and then packaged for subsequent specialized small-volume use. Water used for parenterals is produced by distillation in most cases.
