C6H11NaO7 218.14

D-Gluconic acid,monosodium salt.
Monosodium D-gluconate [527-07-1].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards á11ñ— USP Potassium Gluconate RS.

Identification—

Chloride á221ñ— A1.0-g portion shows no more chloride than corresponds to 1mLof 0.020Nhydrochloric acid (0.07%).

Sulfate á221ñ— A2.0-g portion dissolved in boiling water shows no more sulfate than corresponds to 1mLof 0.020Nsulfuric acid (0.05%).

Lead á251ñ— Dissolve 1.0g in 25mLof water:the limit is 0.001%.

Heavy metals,Method Iá231ñ— Dissolve 1.0g in 10mLof water,add 6mLof 3Nhydrochloric acid,and dilute with water to 25mL:the limit is 0.002%.

Reducing substances— Transfer 1.0g to a 250-mLconical flask,dissolve in 10mLof water,and add 25mLof alkaline cupric citrate TS.Cover the flask,boil gently for 5minutes,accurately timed,and cool rapidly to room temperature.Add 25mLof 0.6Nacetic acid,10.0mLof 0.1Niodine VS,and 10mLof 3Nhydrochloric acid,and titrate with 0.1Nsodium thiosulfate VS,adding 3mLof starch TSas the endpoint is approached.Perform a blank determination,omitting the specimen,and note the difference in volumes required.Each mLof the difference in volume of 0.1Nsodium thiosulfate consumed is equivalent to 2.7mg of reducing substances (as dextrose):the limit is 0.5%.

Assay— Transfer about 150mg of Sodium Gluconate,accurately weighed,to a suitable conical flask,and dissolve in 75mLof glacial acetic acid,warming if necessary to effect complete solution.Cool,add quinaldine red TS,and titrate with 0.1Nperchloric acid VSto a colorless endpoint.Each mLof 0.1Nperchloric acid is equivalent to 21.81mg of C6H11NaO7.

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 1786

Phone Number:1-301-816-8251