Ethacrynate Sodium for Injection
» Ethacrynate Sodium for Injection is a sterile, freeze-dried powder prepared by the neutralization of Ethacrynic Acid with the aid of Sodium Hydroxide. It contains an amount of ethacrynate sodium equivalent to not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C13H12Cl2O4.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
Labeling Label it to indicate that it was prepared by freeze-drying, having been filled into its container in the form of a true solution.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification, Ultraviolet Absorption 197U
Solution: 50 µg per mL.
Medium: acidified methanol (prepared by adding 9 mL of hydrochloric acid to 100 mL of methanol).
Bacterial endotoxins 85 It contains not more than 5.0 USP Endotoxin Units per mg of ethacrynate sodium.
pH 791: between 5.0 and 7.0, in a solution containing the equivalent of about 50 mg of ethacrynic acid in 50 mL of Sterile Water for Injection.
Other requirements It meets the requirements for Sterility Tests 71 and Uniformity of Dosage Units 905 under Injections 1.
Triethylamine solution, Solvent mixture, Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Ethacrynic Acid Tablets.
Assay preparation Select a number of containers of Ethacrynate Sodium for Injection, the combined contents of which, on the basis of the labeled amount, are equivalent to about 500 mg of ethacrynic acid. Add about 5 mL of Solvent mixture to each container, mix to dissolve the contents, and combine the resulting solutions in a 200-mL volumetric flask. Rinse each container with two additional 5-mL portions of Solvent mixture, add the rinsings to the solution in the volumetric flask, dilute with Solvent mixture to volume, and mix. Transfer 20.0 mL of this solution to a 100-mL volumetric flask, dilute with Solvent mixture to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Ethacrynic Acid Tablets. Calculate the quantity, in mg, of C13H12Cl2O4 in each container of Ethacrynate Sodium for Injection taken by the formula:
(1000C/N)(rU / rS)in which N is the number of containers selected for the Assay preparation.
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USP35NF30 Page 3121Pharmacopeial Forum: Volume No. 27(4) Page 2731