C28H38O19 678.59

-D-Glucopyranoside, 1,3,4,6-tetra-O-acetyl--D-fructofuranosyl, tetraacetate.
Sucrose octaacetate [126-14-7].

Packaging and storage— Preserve in tight containers.

Melting temperature 741: not lower than 78.

Acidity— Dissolve 1 g in 20 mL of neutralized alcohol, and add 2 drops of phenolphthalein TS: not more than 2 drops of 0.1 N sodium hydroxide are required to produce a red color.

Water, Method I 921: not more than 1.0%.

Residue on ignition 281: not more than 0.1%.

Residual solvents 467: meets the requirements.

Assay— Transfer about 100 mg of Sucrose Octaacetate, accurately weighed, to a 500-mL conical flask, and dissolve in about 50 mL of 70 percent alcohol. Neutralize the solution with 0.1 N sodium hydroxide VS, using phenolphthalein TS as the indicator. Add 25.0 mL of 0.1 N sodium hydroxide VS, attach an air condenser to the flask, protect from absorption of carbon dioxide, and reflux on a steam bath for 1 hour. Remove from the steam bath, cool quickly, and titrate the excess alkali with 0.1 N sulfuric acid VS, using phenolphthalein TS as the indicator. Perform a blank determination (see Residual Titrations under Titrimetry 541). Each mL of 0.1 N sodium hydroxide is equivalent to 8.483 mg of C28H38O19.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3444

Phone Number : 1-301-816-8262