Sterile Water for Inhalation
note—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 
1231
.
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.
85—
It contains less than 0.5 USP Endotoxin Unit per mL.
Sterility 71:
meets the requirements.
71:
meets the requirements.
Water conductivity 645—
Perform Stage 2, Step 4 using a sufficient amount of water to perform the test. The conductivity is not more than 25 µS/cm for containers with a nominal volume of 10 mL or less at 25 ± 1
; and not more than 5 µS/cm for containers with a nominal volume greater than 10 mL at 25 ± 1.
645—
Perform Stage 2, Step 4 using a sufficient amount of water to perform the test. The conductivity is not more than 25 µS/cm for containers with a nominal volume of 10 mL or less at 25 ± 1; and not more than 5 µS/cm for containers with a nominal volume greater than 10 mL at 25 ± 1.
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 0.02 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.
| Topic/Question | Contact | Expert Committee |
| Monograph | Gary E. Ritchie, M.Sc.
Scientific Fellow 1-301-816-8353 |
(PW05) Pharmaceutical Waters 05 |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3871
Pharmacopeial Forum: Volume No. 31(3) Page 802