Potassium Chloride in Dextrose and Sodium Chloride Injection
» Potassium Chloride in Dextrose and Sodium Chloride Injection is a sterile solution of Potassium Chloride, Dextrose, and Sodium Chloride in Water for Injection. It contains not less than 95.0 percent and not more than 110.0 percent of the labeled amounts of potassium (K) and chloride (Cl) and not less than 95.0 percent and not more than 105.0 percent of the labeled amounts of dextrose (C6H12O6·H2O) and sodium (Na). It contains no antimicrobial agents.
Packaging and storage Preserve in single-dose containers, preferably of Type I or Type II glass, or of a suitable plastic.
Labeling The label states the potassium, sodium, and chloride contents in terms of milliequivalents in a given volume. The label states also the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, the label alternatively may state the total osmolar concentration in mOsmol per mL.
USP Reference standards 11
USP Endotoxin RS.
A: It responds to the flame test for Sodium 191.
B: To 2 mL of Injection add 5 mL of sodium cobaltinitrite TS: a yellow precipitate is formed immediately. If necessary, centrifuge the solution and examine the precipitate (presence of potassium).
C: It responds to the tests for Chloride 191.
D: It responds to the Identification test under Dextrose.
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791: between 3.5 and 6.5.
Heavy metals 231 Transfer to a suitable vessel a volume, in mL, of Injection, calculated to two significant figures by the formula:
0.2/[(GKLK) + (GDLD) + (GSLS)]in which GK, GD, and GS are the labeled amounts, in g, of potassium chloride, dextrose, and sodium chloride, respectively, in each 100 mL of Injection, and LK, LD, and LS are the limits, in percentage, for Heavy metals specified under Potassium Chloride, Dextrose, and Sodium Chloride, respectively. Adjust the volume by evaporation or addition of water to 25 mL, as necessary: it passes the test.
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 under Injections 1.
Assay for potassium and sodium
Internal standard solution, Potassium stock solution, Sodium stock solution, Stock standard preparation, and Standard preparation Prepare as directed in the Assay for potassium and sodium under Potassium Chloride in Sodium Chloride Injection.
Assay preparation Transfer 5.0 mL of Potassium Chloride in Dextrose and Sodium Chloride Injection to a 500-mL volumetric flask, dilute with Internal standard solution to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay for potassium and sodium under Potassium Chloride in Sodium Chloride Injection.
Assay for chloride Transfer an accurately measured volume of Injection, equivalent to about 55 mg of 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 3.545 mg of Cl. Each mg of chloride is equivalent to 0.0282 mEq of Cl.
Assay for dextrose Transfer an accurately measured volume of Injection, containing between 2 g 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.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3340Pharmacopeial Forum: Volume No. 30(5) Page 1641