Sodium Chloride Injection is a sterile
solution of Sodium Chloride in Water for Injection. lt contains no antimicrobial
agents. lt 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 liter. 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: USP Endotoxin RS. Identification: It responds to the tests for Sodium and for Chloride. Bacterial endotoxins: 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 ís between 3.0% and 24.3%. pH: between 4.5 and 7.0. Particulate matter: meets the requirements under Small Volume Injections. Iron: 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 1: 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 mg
of Pb) in the Standard Preparation and in the Monitor
Other requirements: It meets the requirements under Injections (Sterility - Particulate matter) Assay: Pipet a volume of Injection, equivalent to about 90 mg of sodium chloride, into a porcelain casserole, and add 140 mL of water and 1 mL of dichlorofluorescein TS. Mix, and titrate with 0. 1 N silver nitrate VS until the silver chloride flocculates and the mixture acquires a faint pink color. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of NaCl |