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Sterile Water for Inhalation
NOTE—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 1231.
» Sterile Water for Inhalation is prepared from Water for Injection that is sterilized and suitably packaged. It contains no antimicrobial agents, except where used in humidifiers or other similar devices and where liable to contamination over a period of time, or other added substances.
NOTE—Do not use Sterile Water for Inhalation for parenteral administration or for other sterile compendial dosage forms.
Packaging and storage— Preserve in glass or plastic containers. Glass containers are preferably of Type I or Type II glass.
Labeling— Label it to indicate that it is for inhalation therapy only and that it is not for parenteral administration.
Bacterial endotoxins 85 It contains less than 0.5 USP Endotoxin Unit per mL.
Sterility 71: meets the requirements.
pH 791: between 4.5 and 7.5, in a solution containing 0.3 mL of saturated potassium chloride solution per 100 mL of test specimen.
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 using 1.76 mL of 1.0 N ammonium hydroxide) 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 Inhalation in containers having a fill volume of less than 50 mL, add 0.4 mL of 0.1 N potassium permanganate, and boil for 5 minutes; where the fill volume is 50 mL or more, add 0.2 mL of 0.1 N 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— Staff Liaison : Gary E. Ritchie, M.Sc., Scientific Fellow
Expert Committee : (PW05) Pharmaceutical Waters 05
USP29–NF24 Page 2264
Pharmacopeial Forum : Volume No. 31(3) Page 802
Phone Number : 1-301-816-8353