Sodium Acetate Injection
»Sodium Acetate Injection is a sterile solution of Sodium Acetate in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of CH3COONa.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.
Labeling— The label states the sodium acetate content in terms of weight and of milliequivalents in a given volume.Label the Injection to indicate that it is to be diluted to appropriate strength with water or other suitable fluid prior to administration.The label states also the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,or where the label states that the Injection is not for direct injection but is to be diluted before use,the label alternatively may state the total osmolar concentration in mOsmol per mL.
Identification— It responds to the tests for Sodium á191ñand for Acetate á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 3.90USP Endotoxin Units per mEq.
pHá791ñ: between 6.0and 7.0.
Particulate matter á788ñ: meets the requirements under Small-volume Injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard stock solution— Dissolve 570.0mg of sodium chloride,previously dried at 105for 2hours,in 100mLof water,transfer to a 1000-mLvolumetric flask,dilute with water to volume,and mix.Each mLof this solution contains 224µg of sodium,equivalent to 800µg of anhydrous sodium acetate.
Standard preparations— Transfer to each of four 100-mLvolumetric flasks 10mLof a nonionic wetting agent (1in 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,and 15.0mLof Standard stock solution,dilute with water to volume,and mix.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 800mg of anhydrous sodium acetate,to a 1000-mLvolumetric flask,dilute with water to volume,and mix.Pipet 10mLof this solution into a 100-mLvolumetric flask containing 10mLof a nonionic wetting agent (1in 500),dilute with water to volume,and mix.
Standard graph— Set a flame photometer for maximum transmittance at a wavelength of about 589nm.Adjust the instrument to zero transmittance with the blank,and to 100%transmittance with the most concentrated of the Standard preparations.Read the transmittances of the other Standard preparations,and plot transmittances versus equivalent concentration of sodium acetate.
Procedure— Adjust the instrument as directed under Standard graph,read the transmittance of the Assay preparation,and calculate the sodium acetate content,in mg per mL,of Injection.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1774
Phone Number:1-301-816-8379