generation of pharmaceutical water.pdf

The United States Pharmacopeia (USP) defines several types of water including: Purified Water, Water for Injection, Sterile Purified Water, Sterile Water for Injection, Sterile Bacteriostatic Water for Injection, Sterile Water for Inhalation, and Sterile Water for Irrigation. The USP states qualifications for sterility and packaging methods that delineate between the various specific types of water. However, there are two basic types of water preparation, Water for Injection and Purified Water. The analytical standards for these two types of water are very similar, differing in the fact that Water for Injection has stricter bacterial count standards and must also pass the bacterial endotoxin test. Preparation methods are very similar to a point, however, Water for Injection preparation must incorporate distillation or double pass reverse osmosis. Discussion of the various methodologies used in preparation of USP water applies equally to Purified Water (PW) and Water for Injection (WFI).