Packaging and storage— Preserve in tight containers.

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 (distinction from sucrose).

Acidity— To a solution of 5.0g in 15mLof water add 5drops of phenolphthalein TS:not more than 0.60mLof 0.10Nsodium hydroxide is required to produce a pink color.

Water,Method Ia á921ñ: not more than 21.0%,determined on a 100-mg specimen.

Residue on ignition á281ñ: not more than 0.5%.

Sulfite— Dissolve 5g in 50mLof water,add 0.2mLof 0.1Niodine,then add 0.5mLof starch TS:a blue color is produced.

Heavy metals á231ñ— Mix 2.0g with water to make 25mL:the limit is 0.001%.

Starch— Dissolve 5g in 50mLof water,boil the solution for 1minute,cool,and add 0.2mLof 0.1Niodine:no blue color is produced.

Organic volatile impurities,Method Iá467ñ: meets the requirements.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 3011

Phone Number:1-301-816-8379