Sterile water for injection is available in single-dose glass or plastic vials and prefilled syringes in sizes ranging from 1 to 100 mL, and pharmacy bulk packages in plastic bags in sizes up to 5 L.3630; 3631; 3632 This diluent is a pharmaceutical aid which contains no bacteriostat, antimicrobial agent, or buffer and is intended for diluting or dissolving drugs for parenteral use, or for the preparation of intravenous admixtures.3630; 3631; 3632
pH
Osmolality
Sterile water for injection has an osmolality of 0 mOsm/kg.3632 Intravenous administration of sterile water for injection without a solute may result in hemolysis.3630; 3631; 3632
Sterile water for injection must not be administered intravenously without the addition of a sufficient amount of drugs or other solutes to provide adequate osmolality to make the solution approximately isotonic.3630; 3631; 3632 Death and injury have resulted from hemolysis caused by intravenous administration of a sufficient volume of sterile water for injection and other low-osmolality solutions.4; 1942; 2072; 2073; 2481; 2482
For patient safety, medical orders for large volumes of sterile water for injection, especially plastic bags of any size, without the addition of sufficient drug or solute to render the solutions approximately isotonic (about 308 mOsm/kg) should not be permitted. Immediate consultation with the prescriber or referral to the institutional medical peer review process may be necessary to avoid possible patient harm. Large-volume containers of sterile water for injection should be stored only in pharmacies and not in patient care areas. Suitable warnings near the stored product and computer system alerts should remind staff that sterile water for injection is for diluent use only.2481
Intact containers of sterile water for injection should be stored at controlled room temperature.3630; 3631; 3632
For a list of references cited in the text of this monograph, search the monograph titled References.