Packaging and storage— Preserve in tight containers.

Identification— It responds to the tests for Sodium á191ñand for Acetate á191ñ.

pHá791ñ: between 7.5and 9.2,when diluted with carbon dioxide-free water to contain 5%of solids.

Insoluble matter— Dilute a quantity of Solution,equivalent to 20g of anhydrous sodium acetate,with water to 150mL,heat to boiling,and digest in a covered beaker on a steam bath for 1hour.Filter through a tared filtering crucible,wash thoroughly,and dry at 105:the weight of the residue does not exceed 1mg (0.005%).

Chloride á221ñ— Aquantity of Solution,equivalent to 1.0g of anhydrous sodium acetate,shows no more chloride than corresponds to 0.50mLof 0.020Nhydrochloric acid (0.035%).

Sulfate á221ñ— Aquantity of Solution,equivalent to 10g of anhydrous sodium acetate,shows no more sulfate than corresponds to 0.50mLof 0.020Nsulfuric acid (0.005%).

Calcium and magnesium— Dilute a quantity of Solution,equivalent to 1.0g of anhydrous sodium acetate,to 100mLwith water.To 20mLof this solution add 2mLeach of 6Nammonium hydroxide,ammonium oxalate TS,and sodium phosphate TS:no turbidity is produced within 5minutes.

Potassium— To a quantity of Solution,equivalent to 3.0g of anhydrous sodium acetate,add 0.2mLof sodium bitartrate TS:no turbidity is produced within 5minutes.

Heavy metals,Method Iá231ñ— Dilute a quantity of Solution,equivalent to 2.0g of anhydrous sodium acetate,with water to 25mL,and use glacial acetic acid instead of 1Nacetic acid for adjustment of the pH:the limit is 0.001%.

Assay— Weigh accurately about 1g of Solution into a 250-mLconical flask,cautiously add (in a fume hood)2.6mLof acetic anhydride,mix,and allow to stand for 5minutes.Add 25mLof glacial acetic acid and 2drops of p-naphtholbenzein TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,using 0.5mLof water,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 8.203mg of C2H3NaO2.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1775

Phone Number:1-301-816-8379