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 46.5mg and not more than 53.5mg of morrhuate sodium.Asuitable antimicrobial agent,not to exceed 0.5percent,and ethyl alcohol or benzyl alcohol,not to exceed 3.0percent,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 Iglass.It may be packaged in 50-mLmultiple-dose containers.
Identification—
Evaporate about 5mLof the chloroform solution of the fatty acids obtained in the test for Iodine value of the fatty acidson a steam bath nearly to dryness,dissolve the residue in 1mLof chloroform,and add 1drop of sulfuric acid:a transient red color is produced,and it changes to brown-red.
Bacterial endotoxins á85ñ—
It contains not more than 1.4USP Endotoxin Units per mg of morrhuate sodium.
Acidity and alkalinity—
To 5mLof Injection add 5mLof alcohol and 2drops of phenolphthalein TS.If no red color is produced,not more than 0.50mLof 0.10Nsodium hydroxide is required to impart a distinct red color.If a red color is produced,not more than 0.30mLof 0.10Nacid 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-mLconical 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 18hours,and weigh.Dissolve the residue in chloroform to make 100.0mLof solution,and determine the iodine value (see Fats and Fixed Oils á401ñ)on a 25.0-mLaliquot of the solution:the iodine value is not less than 130.
to dryness,dry the residue in vacuum over silica gel for 18hours,and weigh.Dissolve the residue in chloroform to make 100.0mLof solution,and determine the iodine value (see Fats and Fixed Oils á401ñ)on a 25.0-mLaliquot of the solution:the iodine value is not less than 130.
Other requirements—
It meets the requirements under Injections á1ñ,except that at times it may show a slight turbidity or precipitate.
Assay—
Transfer an accurately measured volume of Injection,equivalent to about 500mg of morrhuate sodium,to a small separator containing 30.0mLof 0.1Nsulfuric acid VS,add 25mLof 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-mLportions 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 0.1Nsodium hydroxide VS.Each mLof 0.1Nsulfuric acid is equivalent to 32.4mg of morrhuate sodium.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1317
Phone Number:1-301-816-8251