Water for Injection
Water for Injection— is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled, and in other pharmaceutical applications, such as cleaning of certain equipment and parenteral product-contact components. The minimum quality of source or feed water for the generation of Water for Injection is Drinking Water as defined by the U.S. Environmental Protection Agency (EPA), EU, Japan, or WHO. This source water may be pretreated to render it suitable for subsequent distillation (or whatever other validated process is used according to the monograph). The finished water must meet all of the chemical requirements specified in the monograph as well as an additional bacterial endotoxin specification. Because endotoxins are produced by the kinds of microorganisms that are prone to inhabit water, the equipment and procedures used by the system to purify, store, and distribute Water for Injection must be designed to minimize or prevent microbial contamination as well as remove incoming endotoxins from the starting water. Water for Injection systems must be validated to reliably and consistently produce and distribute this quality of water. The Water for Injection monograph also allows bulk packaging for commercial use. In contrast to Sterile Water for Injection , bulk packaged Water for Injection is not required to be sterile. However, to preclude significant changes in its microbial and endotoxins content during storage, this form of Water for Injection should be prepared and stored in a fashion that limits microbial growth and/or is simply used in a timely fashion before microbial proliferation renders it unsuitable for its intended use. Also depending on the material used for packaging, there could be extractable compounds leaching into the water from the packaging. Although this article is required to meet the same chemical purity limits as the bulk water, packaging extractables will render the packaged water less pure than the bulk water. The nature of these impurities may even render the water an inappropriate choice for some applications. It is the user's responsibility to ensure fitness for use of this packaged article when used in manufacturing, clinical, or analytical applications where the purer bulk form of the water is indicated.