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 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 where the labeled amount of sodium chloride in the Injection is between 0.5% and 0.9%, and not more than 3.6 USP Endotoxin Units per mL where the labeled amount of sodium chloride in the Injection is between 3.0% and 24.3%.
pH 791: between 4.5 and 7.0.
Particulate matter 788: meets the requirements.
Iron 241 Dilute 5.0 mL of Injection with water to 45 mL, and add 2 mL of hydrochloric acid: the limit is 2 ppm.
Heavy metals, Method I 231 Place a volume of Injection, equivalent to 1.0 g of sodium chloride, in a suitable vessel, if necessary evaporate to a volume of about 20 mL, add 2 mL of 1 N acetic acid, then dilute with water to 25 mL. Proceed as directed, except to use 1 mL of Standard Lead Solution (10 µg of Pb) in the Standard Preparation and in the Monitor Preparation: the limit is 0.001%, based on the amount of sodium chloride.
Other requirements— It meets the requirements under Injections 1.
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.
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Topic/Question Contact Expert Committee
Monograph Mary S. Waddell
Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 4654
Pharmacopeial Forum: Volume No. 27(4) Page 2777