Morrhuate Sodium Injection
» Morrhuate Sodium Injection is a sterile solution of the sodium salts of the fatty acids of Cod Liver Oil. It contains, in each mL, not less than 46.5 mg and not more than 53.5 mg of morrhuate sodium. A suitable antimicrobial agent, not to exceed 0.5 percent, and ethyl alcohol or benzyl alcohol, not to exceed 3.0 percent, may be added.
[note—Morrhuate Sodium Injection may show a separation of solid matter on standing. Do not use the material if such solid does not dissolve completely upon warming. ]
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass. It may be packaged in 50-mL multiple-dose containers.
USP Reference standards 11
USP Endotoxin RS
Identification— Evaporate about 5 mL of the chloroform solution of the fatty acids obtained in the test for Iodine value of the fatty acids on a steam bath nearly to dryness, dissolve the residue in 1 mL of chloroform, and add 1 drop of sulfuric acid: a transient red color is produced, and it changes to brown-red.
Bacterial endotoxins 85 It contains not more than 1.4 USP Endotoxin Units per mg of morrhuate sodium.
Acidity and alkalinity— To 5 mL of Injection add 5 mL of alcohol and 2 drops of phenolphthalein TS. If no red color is produced, not more than 0.50 mL of 0.10 N sodium hydroxide is required to impart a distinct red color. If a red color is produced, not more than 0.30 mL of 0.10 N acid is required to discharge it. For concentrations of morrhuate sodium other than 5%, no larger than proportional volumes of alkali and acid are required.
Iodine value of the fatty acids— Transfer to a tared, 125-mL conical flask the solvent hexane solution of the fatty acids obtained in the Assay. Evaporate at about 60 to dryness, dry the residue in vacuum over silica gel for 18 hours, and weigh. Dissolve the residue in chloroform to make 100.0 mL of solution, and determine the iodine value (see Fats and Fixed Oils 401) on a 25.0-mL aliquot of the solution: the iodine value is not less than 130.
Other requirements— It meets the requirements under Injections 1, except that at times it may show a slight turbidity or precipitate.
Assay— Transfer an accurately measured volume of Injection, equivalent to about 500 mg of morrhuate sodium, to a small separator containing 30.0 mL of 0.1 N sulfuric acid VS, add 25 mL of solvent hexane, shake gently, and allow to separate. Withdraw the aqueous layer into a beaker or flask, and wash the solvent hexane layer with two 10-mL portions of water, adding the washings to the main aqueous solution. Retain the hexane solution for the test for Iodine value of the fatty acids. Add methyl orange TS, and titrate the excess acid in the aqueous solution with 0.1 N sodium hydroxide VS. Each mL of 0.1 N sulfuric acid is equivalent to 32.4 mg of morrhuate sodium.
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Monograph Elena Gonikberg, Ph.D.
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USP35–NF30 Page 3959