Sterile Water for Injection
noteFor microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 1231.
» 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 85 It contains less than 0.25 USP Endotoxin Unit per mL.
Sterility 71: meets the requirements.
pH 791: between 5.0 and 7.0 in a solution containing 0.3 mL of saturated potassium chloride solution per 100 mL of test specimen.
Particulate matter 788: meets the requirements.
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 661), and use this dilution as the test solution; where the fill volume is 50 mL or more, use 100 mL of it as the test solution. To 100 mL of the test solution add 2 mL of alkaline mercuric-potassium iodide TS: any yellow color produced immediately is not darker than that of a control containing 30 µg of added ammonia (furnished by adding 1 mL of the final solution prepared by diluting 3.0 mL of ammonia TS with High-Purity Water to 100 mL; 1.0 mL of this solution is further diluted to 100 mL) in 100 mL of High-Purity Water. This corresponds to a limit of 0.6 mg per L for containers having a fill volume of less than 50 mL and 0.3 mg per L where the fill volume is 50 mL or more.
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 661) containing 10 µg of chloride (0.5 mg per L), viewed downward over a dark surface with light entering the tubes from the sides.
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.
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USP32NF27 Page 3871Pharmacopeial Forum: Volume No. 31(3) Page 803