STERILE WATER FOR INHALATION is Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of inhalation solutions.
This monograph has no requirement to meet a Particulate Matter in Injections; it carries a less stringent specification for bacterial endotoxins than Sterile Water for Injection, and therefore is not suitable for parenteral applications.
Monograph
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
TOTAL ORGANIC CARBON USP <643>, Procedures, Sterile Water: Meets the requirements
WATER CONDUCTIVITY USP <645>, Sterile Water: Meets the requirements
STERILITY TESTS USP <71>, Meets the requirements
BACTERIAL ENDOTOXINS TEST USP <85>, Less than 0.5 USP Endotoxin Units/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.
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