U.S. PHARMACOPEIA

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Lactated Ringer's Injection
» Lactated Ringer's 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 14.2 mg and not more than 17.3 mg of potassium (K, equivalent to not less than 27.0 mg and not more than 33.0 mg of KCl), 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), not less than 368.0 mg and not more than 408.0 mg of chloride (Cl, as NaCl, KCl, and 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). Lactated Ringer's Injection contains no antimicrobial agents.
NOTE—The calcium, potassium, and sodium contents of Lactated Ringer's Injection are approximately 2.7, 4, and 130 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.”
Identification—
A: It responds to the flame tests for Sodium 191 and for Potassium 191, to the ammonium oxalate test for Calcium 191, and to the tests for Chloride 191.
B: 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 6.0 and 7.5.
Heavy metals 231— Evaporate 67 mL to a volume of 20 mL, add 2 mL of 1 N acetic acid, then dilute with water to 25 mL: the limit is 0.3 ppm.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay for calcium— Proceed with Injection as directed in the Assay for calcium under Ringer's Injection.
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— Prepare a solution in water containing about 1 mL of formic acid and 1 mL of dicyclohexylamine per liter, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Resolution solution— Prepare a solution in water containing about 3 mg of anhydrous sodium acetate and 3 mg of USP Sodium Lactate RS per mL.
Standard preparation— Dissolve an accurately weighed quantity of USP Sodium Lactate RS in water to obtain a solution having a known concentration of about 3 mg per mL.
Assay preparation— Use undiluted Injection.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 10-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the resolution, R, between the acetate peak and the lactate peak is not less than 2. Chromatograph the Standard preparation, and record the responses as directed for Procedure: the tailing factor for the analyte peak is not more than 2.0, and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparations and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of lactate (C3H5O3) in the Injection taken by the formula:
C(89.07 / 112.06)(rU / rS),
in which C is the concentration, in mg per mL, of USP Sodium Lactate RS in the Standard preparation, 89.07 and 112.06 are the molecular weights of lactate (C3H5O3) and anhydrous sodium lactate (C3H5NaO3), respectively, and rU and rS are the lactate peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1927
Phone Number : 1-301-816-8143