Sterile Water for Inhalation
11
[Note—For microbiological guidance, see Water for Pharmaceutical Purposes 1231. ]
1231. ]
Change to read:
(ERR 1-Oct-2014)
DEFINITION
Sterile Water for Inhalation is prepared from Water for Injection that is sterilized and suitably packaged. It contains no added antimicrobial agents. [Note—Do not use Sterile Water for Inhalation for parenteral administration or for other sterile compendial dosage forms. ]
SPECIFIC TESTS
• Oxidizable Substances
Sample:
100 mL
Analysis:
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 min; where the fill volume is 50 mL or more, add 0.2 mL of 0.02 M potassium permanganate, and boil for 5 min. If a precipitate forms, cool in an ice bath to room temperature, and pass through a sintered-glass filter.
Acceptance criteria:
The pink color does not completely disappear. Alternatively, perform the test for Total Organic Carbon 643, Sterile Water.
643, Sterile Water.
• Total Organic Carbon, Sterile Water 643:
Meets the requirements. Alternatively, perform the test for Oxidizable Substances.
643:
Meets the requirements. Alternatively, perform the test for Oxidizable Substances.
• Water Conductivity, Sterile Water 645:
Meets the requirements
645:
Meets the requirements
• Sterility Tests 71:
Meets the requirements
71:
Meets the requirements
• Bacterial Endotoxins Test 85:
Less than 0.5 USP Endotoxin Unit/mL
85:
Less than 0.5 USP Endotoxin Unit/mL
ADDITIONAL REQUIREMENTS
• 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.
Change to read:
• USP Reference Standards 11
(ERR 1-Oct-2014)
USP Endotoxin RS
(ERR 1-Oct-2014)
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Antonio Hernandez-Cardoso, M.Sc.
Senior Scientific Liaison (301) 816-8308 |
(GCCA2010) General Chapters - Chemical Analysis |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison (301) 816-8339 |
(GCM2010) General Chapters - Microbiology |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison (301) 816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 5806
Pharmacopeial Forum: Volume No. 38(3)