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 Identification test under Dextrose, and to the tests for Sodium 191 and for Chloride 191.

Bacterial endotoxins 85— It contains not more than 10.0 USP Endotoxin Units per g of dextrose.

pH 791: between 3.2 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 under Injections 1.

Assay for dextrose— Transfer an accurately measured volume of Injection, containing from 2 to 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 sodium chloride— Transfer an accurately measured volume of Injection, equivalent to about 90 mg of sodium chloride, to a conical flask, 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 668

Phone Number : 1-301-816-8143