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. The content of potassium, in milliequivalents, is prominently displayed on the label.

USP Reference standards 11— USP Endotoxin RS.

Identification— It responds to the Identification test under Dextrose, to the flame test for Potassium 191, and to the tests for Chloride 191.

Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mL.

pH 791: between 3.5 and 6.5, determined on a portion diluted with water, if necessary, to a concentration of not more than 5% of dextrose.

Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection, equivalent to 1.0 g of C6H12O6·H2O, with water to 500.0 mL. Determine the absorbance of this solution in a 1-cm cell at 284 nm, with a suitable spectrophotometer, using water as the blank: the absorbance is not more than 0.25.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements of the test for Heavy metals under Dextrose Injection, and meets the requirements under Injections 1.

Assay for dextrose— Transfer an accurately measured volume of Injection, containing between 2 and 5 g of dextrose, to a 100-mL volumetric flask. Add 0.2 mL of 6 N ammonium hydroxide, dilute with water to volume, and mix. Determine the angular rotation in a suitable polarimeter tube (see Optical Rotation 781). Calculate the percentage (g per 100 mL) of dextrose (C6H12O6·H2O) in the portion of Injection taken by the formula: in which 100 is the percentage; 52.9 is the midpoint of the specific rotation range for anhydrous dextrose, in degrees; 198.17 and 180.16 are the molecular weights for dextrose monohydrate and anhydrous dextrose, respectively; A is 100 mm divided by the length of the polarimeter tube, in mm; and R is the observed rotation, in degrees.

Assay for potassium chloride— Transfer an accurately measured volume of Injection, equivalent to between 75 and 150 mg of potassium chloride, to 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 7.455 mg of KCl.

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

USP29–NF24 Page 1763

Phone Number : 1-301-816-8143