Sterile Water for Injection
noteFor microbiological guidance, see general information chapter Water for Pharmaceutical Purposes
![]() ![]() » Sterile Water for Injection is prepared from Water for Injection that is sterilized and suitably packaged. It contains no antimicrobial agent or other added substance.
Packaging and storage
Preserve in single-dose glass or plastic containers, of not larger than 1-L size. Glass containers are preferably of Type I or Type II glass.
Labeling
Label it to indicate that no antimicrobial or other substance has been added, and that it is not suitable for intravascular injection without first having been made approximately isotonic by the addition of a suitable solute.
Bacterial endotoxins
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Sterility
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pH
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Particulate matter
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Ammonia
For containers having a fill volume of less than 50 mL, dilute 50 mL of it with 50 mL of High-Purity Water (see Reagents under Containers
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Calcium
To 100 mL add 2 mL of ammonium oxalate TS: no turbidity is produced.
Carbon dioxide
To 25 mL add 25 mL of calcium hydroxide TS: the mixture remains clear.
Chloride
To 20 mL in a color-comparison tube add 5 drops of nitric acid and 1 mL of silver nitrate TS, and gently mix: any turbidity formed within 10 minutes is not greater than that produced in a similarly treated control consisting of 20 mL of High-Purity Water (see Reagents under Containers
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Sulfate
To 100 mL add l mL of barium chloride TS: no turbidity is produced.
Oxidizable substances
To 100 mL add 10 mL of 2 N sulfuric acid, and heat to boiling. For Sterile Water for Injection in containers having a fill volume of less than 50 mL, add 0.4 mL of 0.02 M potassium permanganate, and boil for 5 minutes; where the fill volume is 50 mL or more, add 0.2 mL of 0.02 M potassium permanganate, and boil for 5 minutes. If a precipitate forms, cool in an ice bath to room temperature, and pass through a sintered-glass filter: the pink color does not completely disappear.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3871
Pharmacopeial Forum: Volume No. 31(3) Page 803
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