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.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 1976

Phone Number : 1-301-816-8143