Modified Lactated Ringer's and Dextrose Injection
» Modified Lactated Ringer's and Dextrose Injection is a sterile solution of Calcium Chloride, Potassium Chloride, Sodium Chloride, Sodium Lactate, and Dextrose in Water for Injection. It contains, in each 100 mL, not less than 57.0 mg and not more than 63.0 mg of sodium (as NaCl and C3H5NaO3), not less than 2.82 mg and not more than 3.46 mg of potassium (K, equivalent to not less than 5.4 mg and not more than 6.6 mg of KCl), not less than 0.98 mg and not more than 1.20 mg of calcium (Ca, equivalent to not less than 3.6 mg and not more than 4.4 mg of CaCl2·2H2O), not less than 73.6 mg and not more than 85.6 mg of chloride (Cl, as NaCl, KCl, and CaCl2·2H2O), and not less than 46.2 mg and not more than 52.20 mg of lactate (C3H5O3, equivalent to not less than 58.0 mg and not more than 66.0 mg of C3H5NaO3). It contains not less than 90.0 percent and not more than 105.0 percent of the labeled amount of dextrose (C6H12O6·H2O). It contains no antimicrobial agents.
[noteThe calcium, potassium, and sodium contents of Modified Lactated Ringer's and Dextrose Injection are approximately 0.5, 0.8, and 26 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. The label includes also the warning: Not for use in the treatment of lactic acidosis.
USP Reference standards 11
USP Endotoxin RS
A: It responds to the Identification test under Dextrose.
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 4.0 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.
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, Dilute hydrochloric acid, Blank solution, Calcium stock solution, and Standard preparations Prepare as directed in the Assay for calcium under Ringer's Injection.
Assay preparation Transfer 5.0 mL of Lanthanum chloride solution to a 100-mL volumetric flask, dilute with Injection 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:
0.105Cin which C is the concentration, in µg per mL, of calcium in the Assay preparation, as determined from the graph.
Assay for potassium
Standard stock solution, Standard preparations, and Standard graph Proceed as directed in the Assay for potassium under Ringer's Injection.
Assay preparation Transfer 50.0 mL of Injection to a 100-mL volumetric flask, add 10.0 mL of a solution of a suitable wetting agent (1 in 500), dilute with water to volume, and mix.
Procedure Adjust the instrument as directed under Standard graph, read the percentage transmittance of the Assay preparation, and calculate the potassium content, in mg per 100 mL, of Injection.
Assay for sodium
Standard stock solution and Standard preparationsProceed as directed in the Assay for sodium under Ringer's Injection.
Assay preparation Transfer 25.0 mL of Injection to a 1000-mL volumetric flask containing 100 mL of a solution of a suitable wetting agent (1 in 500), dilute with water to volume, and mix.
Procedure Proceed as directed for Standard graph and for Procedure in the Assay for potassium under Ringer's Injection, setting the flame photometer for maximum transmittance at a wavelength of about 589 nm, instead of about 766 nm. Calculate the sodium content, in mg per 100 mL, of 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, Chromatographic system, and Procedure Proceed as directed in the Assay for lactate under Lactated Ringer's Injection.
Standard preparation Dissolve an accurately weighed quantity of USP Sodium Lactate RS in water to obtain a solution having a known concentration of about 0.6 mg per mL.
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.
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USP35NF30 Page 4567