U.S. PHARMACOPEIA

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Sodium Chloride Irrigation
» Sodium Chloride Irrigation is Sodium Chloride Injection that has been suitably packaged, and it contains no antimicrobial agents. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of NaCl.
Packaging and storage— Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass. The container may be designed to empty rapidly and may contain a volume of more than 1 L.
Labeling— The designation “not for injection” appears prominently on the label.
Identification— It responds to the tests for Sodium 191 and for Chloride 191.
Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mL.
Sterility 71: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for pH, Iron, Heavy metals, and Assay under Sodium Chloride Injection.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1977
Phone Number : 1-301-816-8143