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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 95.0percent and not more than 105.0percent of the labeled amount of NaCl.
Packaging and storage—
Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type Ior Type IIglass.The container may be designed to empty rapidly and may contain a volume of more than 1liter.
Labeling—
The designation “not for injection”appears prominently on the label.
Identification—
It responds to the tests for Sodium á191ñand for Chloride á191ñ.
Bacterial endotoxins á85ñ—
It contains not more than 0.5USP Endotoxin Unit per mL.
Sterility á71ñ:
meets the requirements.
Other requirements—
It meets the requirements for pH,Iron,Heavy metals,and Assayunder Sodium Chloride Injection.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1781
Phone Number:1-301-816-8379
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