Purified Water— is used as an excipient in the production of nonparenteral preparations and in other pharmaceutical applications, such as cleaning of certain equipment and nonparenteral product-contact components. Unless otherwise specified, Purified Water is also to be used for all tests and assays for which water is indicated.
Purified Water must meet the requirements for ionic and organic chemical purity and must be protected from microbial contamination.
The minimal quality of source or feed water for the production of Purified Water is Drinking Water.
This source water may be purified using unit operations that include deionization, distillation, ion exchange, reverse osmosis, filtration, or other suitable purification procedures.
Purified water systems must be validated to reliably and consistently produce and distribute water of acceptable chemical and microbiological quality.
Purified water systems that function under ambient conditions are particularly susceptible to the establishment of tenacious biofilms of microorganisms, which can be the source of undesirable levels of viable microorganisms or endotoxins in the effluent water.
These systems require frequent sanitization and microbiological monitoring to ensure water of appropriate microbiological quality at the points of use.
The Purified Water monograph (USP) also allows bulk packaging for commercial use elsewhere. In contrast to Sterile Purified Water, bulk packaged Purified Water is not required to be sterile. Because there is potential for microbial contamination and other quality changes in this bulk packaged non-sterile water, this form of Purified Water 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 pure bulk form of the water is indicated.
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