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.
USP Reference standards 11
USP Endotoxin RS
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.
Other requirements— It meets the requirements for pH, Iron, Heavy metals, and Assay under Sodium Chloride Injection.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Mary S. Waddell
Scientific Liaison
1-301-816-8124
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 4655