Packaging and storage— Preserve in tight containers.

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

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

Water, Method Ia 921: not more than 21.0%, determined on a 100-mg specimen.

Residue on ignition 281: not more than 0.5%.

Sulfite— Dissolve 5 g in 50 mL of water, add 0.2 mL of 0.1 N iodine, then add 0.5 mL of starch TS: a blue color is produced.

Heavy metals 231— Mix 2.0 g with water to make 25 mL: the limit is 0.001%.

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

Organic volatile impurities, Method I 467: meets the requirements.

Residual solvents 467: meets the requirements.

Expert Committee : (EM205) Excipient Monographs 2

USP29–NF24 Page 3339

Phone Number : 1-301-816-8351