ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Purified Water, USP

Water rendered suitable for pharmaceutical purposes by using unit operations that include deionization, distillation, ion-exchange, reverse osmosis, filtration, or other suitable purification procedures. It meets rigid specifications for chemical purity, the requirements of the Federal Environmental Protection Agency (EPA) with respect to drinking water, and it contains no added substances. Cannot be used as raw material for parenterals. Common uses are: a rinse for equipment, vials, and ampoules, and as make up for cosmetics, bulk chemicals, and oral products. For FDA acceptance, purified water must contain less than 0.5 mg/l of TOC (Total Organic Carbon), and less than 100 CFU (Colony Forming Units).

Purified Water, USP

Water rendered suitable for pharmaceutical purposes by using unit operations that include deionization, distillation, ion-exchange, reverse osmosis, filtration, or other suitable purification procedures. It meets rigid specifications for chemical purity, the requirements of the Federal Environmental Protection Agency (EPA) with respect to drinking water, and it contains no added substances. Cannot be used as raw material for parenterals. Common uses are: a rinse for equipment, vials, and ampoules, and as make up for cosmetics, bulk chemicals, and oral products. For FDA acceptance, purified water must contain less than 0.5 mg/l of TOC (Total Organic Carbon), and less than 100 CFU (Colony Forming Units).

Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (First Edition)
Publication Date: 2001

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