Ringer's and Dextrose Injection
» Ringer's and Dextrose Injection is a sterile solution of Sodium Chloride, Potassium Chloride, Calcium Chloride, and Dextrose in Water for Injection. It contains, in each 100 mL, not less than 323.0 mg and not more than 354.0 mg of sodium (Na, equivalent to not less than 820.0 mg and not more than 900.0 mg of NaCl), not less than 14.9 mg and not more than 16.5 mg of potassium (K, equivalent to not less than 28.5 mg and not more than 31.5 mg of KCl), not less than 8.20 mg and not more than 9.80 mg of calcium (Ca, equivalent to not less than 30.0 mg and not more than 36.0 mg of CaCl2·2H2O), and not less than 523.0 mg and not more than 608.5 mg of chloride (Cl, as NaCl, KCl, and CaCl2·2H2O). It contains 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.
noteThe calcium, chloride, potassium, and sodium ion contents of Ringer's and Dextrose Injection are approximately 4.5, 156, 4, and 147.5 milliequivalents per liter, respectively.
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.
A: 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 / [(GSLS) + (GKLK) + (GCLC) + (GDLD)]in which GS, GK, GC, and GD are the labeled amounts, in g, of sodium chloride, potassium chloride, calcium chloride, and dextrose, respectively, in each 100 mL of Injection; and LS, LK, LC, and LD are the limits, in percentage, for Heavy metals specified under Sodium Chloride, Potassium Chloride, Calcium Chloride, 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.
Other requirements It meets the requirements under Injections 1.
Assay for calcium [noteConcentrations 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, Blank solution, Calcium stock solution, and Standard preparations Prepare as directed in the Assay for calcium under Ringer's Injection.
Assay preparation Transfer 20.0 mL of Injection (equivalent to about 1.8 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:
0.5Cin 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 dextrose Transfer an accurately measured volume of Injection, containing 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:
(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.
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USP32NF27 Page 3511Pharmacopeial Forum: Volume No. 30(5) Page 1647