Potassium Chloride in Dextrose Injection
» Potassium Chloride in Dextrose Injection is a sterile solution of Potassium Chloride and Dextrose in Water for Injection. It contains not less than 95.0 percent and not more than 110.0 percent of the labeled amount of Potassium Chloride (KCl) and not less than 95.0 percent and not more than 105.0 percent of the labeled amount of dextrose (C6H12O6·H2O). It contains no antimicrobial agents.
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.
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:
(100/52.9)(198.17/180.16)ARin 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.
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USP35NF30 Page 4362Pharmacopeial Forum: Volume No. 30(5) Page 1640