Ringer??? Injection

Ringer's Injection

» Ringer's Injection is a sterile solution of Sodium Chloride, Potassium Chloride, and Calcium Chloride 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 580.0 mg of chloride (Cl, as NaCl, KCl, and CaCl2·2H2O). Ringer's Injection contains no antimicrobial agents.

note—The calcium, chloride, potassium, and sodium ion contents of Ringer's Injection are approximately 4.5, 156, 4, and 147.5 milliequivalents per liter, respectively.

Sodium Chloride	8.6 g
Potassium Chloride	0.3 g
Calcium Chloride	0.33 g
Water for Injection, a sufficient quantity to make	1000 mL

Dissolve the three salts in the Water for Injection, filter until clear, place in suitable containers, and sterilize.

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.

USP Reference standards

—
USP Endotoxin RS.

Identification— It responds to the flame tests for Sodium

191

and Potassium

191

, to the ammonium oxalate test for Calcium

191

, and to the tests for Chloride

191

Bacterial endotoxins

— It contains not more than 0.5 USP Endotoxin Unit per mL.

791

: between 5.0 and 7.5.

Heavy metals

231

— Evaporate 67 mL to a volume of about 20 mL, add 2 mL of 1 N acetic acid, and dilute with water to 25 mL: the limit is 0.3 ppm.

Other requirements— It meets the requirements under Injections

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— Transfer 17.69 g of lanthanum chloride to a 200-mL volumetric flask, add 100 mL of water, and carefully add 50 mL of hydrochloric acid. Mix, and allow to cool. Dilute with water to volume, and mix.

Blank solution— Transfer 5.0 mL of Lanthanum chloride solution to a 100-mL volumetric flask, dilute with water to volume, and mix.

Calcium stock solution— Transfer 499.5 mg of primary standard calcium carbonate to a 200-mL volumetric flask, and add 10 mL of water. Carefully add 5 mL of diluted hydrochloric acid, and swirl to dissolve the calcium carbonate. Dilute with water to volume, and mix. This solution contains 1000 µg of calcium (Ca) per mL.

Standard preparations— To three separate 100-mL volumetric flasks, each containing 5.0 mL of Lanthanum chloride solution, add 1.0, 1.5, and 2.0 mL, respectively, of Calcium stock solution. Dilute the contents of each flask with water to volume, and mix. These three solutions contain, 10.0, 15.0, and 20.0 µg, respectively, of calcium (Ca) per mL.

Assay preparation— Transfer 20.0 mL of Injection, equivalent to about 1.8 mg of calcium (Ca), to a 100-mL volumetric flask containing 5.0 mL of Lathanum chloride solution. Dilute the contents of the flask with water to volume, and mix.

Procedure— Concomitantly determine the absorbances of the Standard preparations and the Assay preparation at the calcium emission line at 422.7 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering

851

) equipped with a calcium hollow-cathode lamp and an air–acetylene flame, using the Blank solution as the blank. Plot the absorbances of the Standard preparations versus concentration, in µg per mL, of calcium, and draw the straight line best fitting the three plotted points. From the graph so obtained, determine the concentration, C, in µg per mL, of calcium in the Assay preparation. Calculate the quantity, in mg, of calcium in each 100 mL of the Injection taken by the formula:

0.5(C).

Assay for potassium—

Standard stock solution— Dissolve 190.7 mg of potassium chloride, previously dried at 105

for 2 hours, in 50 mL of water, transfer to a 1000-mL volumetric flask, dilute with water to volume, and mix. Each mL of this solution contains 100 µg of potassium.

Standard preparations— Dissolve 1.093 g of sodium chloride in 100.0 mL of water, and transfer 10 mL of this solution to each of five 100-mL volumetric flasks containing 10.0 mL of a solution of a suitable nonionic wetting agent (1 in 500). Dilute the contents of one of the flasks with water to volume to provide a blank. To the remaining flasks add, respectively, 5.0, 10.0, 15.0, and 20.0 mL of Standard stock solution, dilute with water to volume, and mix.

Assay preparation— Pipet 10 mL of Injection into 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.

Standard graph— Set a suitable flame photometer for maximum transmittance at a wavelength of about 766 nm. Adjust the instrument to zero transmittance with the blank. Adjust the instrument to 100% transmittance with the most concentrated of the Standard preparations. Read the percentage transmittance of the other Standard preparations, and plot transmittances versus concentration of potassium.

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— Dissolve 254.2 mg of sodium chloride, previously dried at 105

for 2 hours, in 50 mL of water, transfer to a 1000-mL volumetric flask, dilute with water to volume, and mix. Each mL of this solution contains 100 µg of sodium.

Standard preparations— Transfer to each of five 100-mL volumetric flasks 10 mL of a solution of a suitable nonionic wetting agent (1 in 500). Dilute the contents of one of the flasks with water to volume to provide a blank. To the remaining flasks add, respectively, 5.0, 10.0, 15.0, and 20.0 mL of Standard stock solution, dilute with water to volume, and mix.

Assay preparation— Pipet 5 mL of Injection into 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, 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— Pipet 10 mL of Injection into 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.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Daniel K. Bempong, Ph.D. Senior Scientist 1-301-816-8143	(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards	Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org
85	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance

USP32–NF27 Page 3510

Pharmacopeial Forum: Volume No. 27(4) Page 2777