Sodium Chloride Injection
» Sodium Chloride Injection is a sterile solution of Sodium Chloride in Water for Injection. 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.
Labeling
The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol per mL.
USP Reference standards
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USP Endotoxin RS
Identification
It responds to the tests for Sodium
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Bacterial endotoxins
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pH
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Particulate matter
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Iron
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Heavy metals, Method I
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Other requirements
It meets the requirements under Injections
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Assay
Pipet a volume of Injection, equivalent to about 90 mg of sodium chloride, into a conical flask. Add water, if necessary, to bring the volume to about 10 mL, and add 10 mL of glacial acetic acid, 75 mL of methanol, and 3 drops of eosin Y TS. Titrate, with shaking, with 0.1 N silver nitrate VS to a pink endpoint. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of NaCl.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4654
Pharmacopeial Forum: Volume No. 27(4) Page 2777
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