U.S. PHARMACOPEIA

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Dimethyl Sulfoxide Irrigation
» Dimethyl Sulfoxide Irrigation is a sterile solution of Dimethyl Sulfoxide in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C2H6OS.
Packaging and storage— Preserve in single-dose containers, and store at controlled room temperature, protected from strong light.
Labeling— Label it to indicate prominently that it is not intended for injection.
Identification— A portion of the Assay preparation, chromatographed as directed in the Assay, exhibits a major peak for dimethyl sulfoxide, the retention time of which is identical with that exhibited by the Standard preparation.
Bacterial endotoxins 85— It contains not more than 0.5 Endotoxin Unit per mL.
Sterility 71: meets the requirements.
pH 791: between 5.0 and 7.0, when diluted with water to obtain a solution containing 50 mg of dimethyl sulfoxide per mL.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Standard preparation— Dissolve an accurately weighed quantity of USP Dimethyl Sulfoxide RS in acetone, and dilute quantitatively with acetone to obtain a solution having a known concentration of about 80 mg per mL.
Assay preparation— Transfer an accurately measured volume of Dimethyl Sulfoxide Irrigation, equivalent to about 2 g of dimethyl sulfoxide, to a 25-mL volumetric flask, dilute with acetone to volume, and mix.
Chromatographic system (see Chromatography 621)—Proceed as directed in the test for Dimethyl sulfone under Dimethyl Sulfoxide. The relative standard deviation for replicate injections of the Standard preparation is not more than 2.0%.
Procedure— Introduce equal volumes (about 1.0 µL) of the Standard preparation and the Test preparation into the gas chromatograph. Measure the peak responses, at corresponding retention times, so obtained, and calculate the quantity, in mg, of C2H6OS in each mL of Dimethyl Sulfoxide Irrigation taken by the formula:
25(C / V)(rU / rS),
in which C is the concentration, in mg per mL, of USP Dimethyl Sulfoxide RS in the Standard preparation; V is the volume, in mL, of Dimethyl Sulfoxide Irrigation taken; and rU and rS are the peak responses from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 725
Phone Number : 1-301-816-8320