Sterile Monographed Waters

Sterile Monographed Waters The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized to preserve their microbiological properties. These waters may have specific intended uses as indicated by their names, and may also have restrictions on the packaging configurations related to those uses. In general, these sterile waters may be used in a variety of applications in lieu of the bulk forms of water from which they were derived. However, there is a substantial difference between the acceptance criteria for the chemical purities of these bulk waters versus sterile waters. The specifications for sterile waters differ from those of bulk waters to accommodate a wide variety of packaging types, properties, volumes, and uses. As a result, the inorganic and organic impurity specifications are not equivalent for bulk and packaged waters. The packaging materials and elastomeric closures are the primary sources of these impurities, which tend to increase over the shelf life of these packaged articles. Therefore, due consideration must be given to the chemical purity suitability at the time of use of the sterile forms of water when used in manufacturing, analytical, and cleaning applications in lieu of the bulk waters from which these waters were derived. It is the user’s responsibility to ensure fitness for use of these sterile packaged waters in these applications. Nevertheless, for the applications discussed below for each sterile water, their respective purities and packaging restrictions generally render them suitable by definition. STERILE PURIFIED WATER STERILE WATER FOR INJECTION BACTERIOSTATIC WATER FOR INJECTION STERILE WATER FOR IRRIGATION STERILE WATER FOR INHALATION Continue...