C6H12O6·H2O 198.17

D-Glucose,monohydrate.
D-Glucose monohydrate [5996-10-1].

Anhydrous 180.16 [50-99-7].

Packaging and storage— Preserve in well-closed containers.

Labeling— Label it to indicate whether it is hydrous or anhydrous.

Identification— Add a few drops of a solution (1in 20)to 5mLof hot alkaline cupric tartrate TS:a copious red precipitate of cuprous oxide is formed.

Color of solution— Dissolve 25g in water to make 50.0mLof solution:the solution has no more color than a solution prepared by mixing 1.0mLof cobaltous chloride CS,3.0mLof ferric chloride CS,and 2.0mLof cupric sulfate CSwith water to make 10mL,and diluting 3mLof this solution with water to 50mL.Make the comparison by viewing the solutions downward in matched color-comparison tubes against a white surface.

Specific rotation á781Sñ: between +52.6and +53.2.

Acidity— Dissolve 5.0g in 50mLof carbon dioxide-free water.Add phenolphthalein TS,and titrate with 0.020Nsodium hydroxide to the production of a distinct pink color:not more than 0.30mLis required for neutralization.

Water,Method IIIá921ñ— Dry it at 105for 16hours:the hydrous form loses between 7.5%and 9.5%of its weight,and the anhydrous form loses not more than 0.5%of its weight.

Residue on ignition á281ñ: not more than 0.1%.

Chloride á221ñ— A2.0-g portion shows no more chloride than corresponds to 0.50mLof 0.020Nhydrochloric acid (0.018%).

Sulfate á221ñ— A2.0-g portion shows no more sulfate than corresponds to 0.50mLof 0.020Nsulfuric acid (0.025%).

Arsenic,Method Iá211ñ: 1ppm.

Heavy metals á231ñ— Dissolve 4.0g in water to make 25mLof solution:the limit is 5ppm.

Dextrin— Reflux 1g of finely powdered Dextrose with 20mLof alcohol:it dissolves completely.

Soluble starch,sulfites— To a solution of 1g in 10mLof water add 1drop of iodine TS:the liquid is colored yellow.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 612

Phone Number:1-301-816-8379