U.S. PHARMACOPEIA

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Potassium Chloride in Lactated Ringer's and Dextrose Injection
» Potassium Chloride in Lactated Ringer's and Dextrose Injection is a sterile solution of Calcium Chloride, Potassium Chloride, Sodium Chloride, and Sodium Lactate in Water for Injection. It contains, in each 100 mL, not less than 285.0 mg and not more than 315.0 mg of sodium (as NaCl and C3H5NaO3), not less than 4.90 mg and not more than 6.00 mg of calcium (Ca, equivalent to not less than 18.0 mg and not more than 22.0 mg of CaCl2·2H2O), and not less than 231.0 mg and not more than 261.0 mg of lactate (C3H5O3, equivalent to not less than 290.0 mg and not more than 330.0 mg of C3H5NaO3). It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of Potassium Chloride (KCl), not less than 90.0 percent and not more than 105.0 percent of the labeled amount of dextrose (C6H12O6·H2O), and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of chloride (Cl, as NaCl, KCl, and CaCl2·2H2O). 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, the label alternatively may state the total osmolar concentration in mOsmol per mL. The label includes also the warning: “Not for use in the treatment of lactic acidosis.”
Identification—
A: It responds to the Identification test under Dextrose Injection.
B: It responds to the flame tests for Sodium 191 and for Potassium 191, to the test for Chloride 191, and to the ammonium oxalate test for Calcium 191.
C: The retention time of the lactate peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation as obtained in the Assay for lactate.
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 / [(GSLS) + (GKLK) + (GCLC) + (GLLL) + (GDLD)],
in which GS, GK, GC, GL, and GD are the labeled amounts, in g, of sodium chloride, potassium chloride, calcium chloride, sodium lactate, and dextrose, respectively, in each 100 mL of Injection, and LS, LK, LC, LL, and LD are the limits, in percentage, for Heavy metals specified under Sodium Chloride, Potassium Chloride, Calcium Chloride, Sodium Lactate, and Dextrose, respectively. Adjust the volume by evaporation or addition of water to 25 mL, as necessary: it meets the requirements of the test.
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.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay for calcium— [NOTE—Concentrations of the Standard preparations and the Assay preparation may be modified to fit the linear or working range of the atomic absorption spectrophotometer.]
Lanthanum chloride solution and Blank solution— Prepare as directed in the Assay for calcium under Ringer's Injection.
Calcium stock solution and Standard preparations— Prepare as directed in the Assay for calcium under Ringer's Injection.
Assay preparation— Transfer 30.0 mL of Injection (equivalent to about 1.6 mg of calcium), to a 100-mL volumetric flask containing 5.0 mL of Lanthanum chloride solution. Dilute the contents of the flask with water to volume, and mix.
Procedure— Proceed as directed in the Assay for calcium under Ringer's Injection. Calculate the quantity, in mg, of calcium in each 100 mL of the Injection taken by the formula:
C / 3,
in which C is the concentration, in µg per mL, of calcium in the Assay preparation, as determined from the graph.
Assay for potassium— Proceed with Injection as directed in the Assay for potassium under Ringer's Injection.
Assay for sodium— Proceed with Injection as directed in the Assay for sodium under Ringer's Injection.
Assay for chloride— Proceed with Injection as directed in the Assay for chloride under Ringer's Injection.
Assay for lactate—
Mobile phase, Resolution solution, Standard preparation, Chromatographic system, and Procedure— Proceed as directed in the Assay for lactate under Lactated Ringer's Injection.
Assay preparation— Use undiluted Injection.
Procedure— Proceed as directed in the Assay for lactate under Lactated Ringer's Injection. Calculate the concentration, in mg per mL, of lactate (C3H5O3) in the Assay preparation taken by the formula:
C(89.07 / 112.06)(rU / rS),
in which the terms are as defined therein.
Assay for dextrose— Proceed with Injection as directed in the Assay for dextrose under Ringer's and Dextrose Injection.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1764
Phone Number : 1-301-816-8143