C12H22O11 342.30

-D-Glucopyranoside, -D-fructofuranosyl-.
Sucrose [57-50-1].

Packaging and storage— Preserve in well-closed containers.

Specific rotation 781S: not less than +65.9.

Residue on ignition 281: not more than 0.05%, a 5-g specimen being used.

Chloride 221— A 2.0-g portion shows no more chloride than corresponds to 0.10 mL of 0.020 N hydrochloric acid (0.0035%).

Sulfate 221— A 5.0-g portion shows no more sulfate than corresponds to 0.30 mL of 0.020 N sulfuric acid (0.006%).

Calcium— To 10 mL of a solution (1 in 10) add 1 mL of ammonium oxalate TS: the solution remains clear for at least 1 minute.

Heavy metals 231— Dissolve 4.0 g in 15 mL of water, add 1 mL of 0.12 N hydrochloric acid, and dilute with water to 25 mL: the limit is 5 ppm.

Invert sugar— Dissolve 20 g in water to make 100 mL, and filter if necessary. Place 50 mL of the clear liquid in a 250-mL beaker, add 50 mL of alkaline cupric tartrate TS, cover the beaker with a watch glass, and heat the mixture at such a rate that it comes to a boil in approximately 4 minutes, and boil for 2 minutes, accurately timed. Add at once 100 mL of cold, recently boiled water, and immediately collect the precipitated cuprous oxide on a tared filtering crucible containing a sintered-glass disk of medium pore size, or suitable equivalent. Thoroughly wash the residue on the filter with hot water, then with 10 mL of alcohol, and finally with 10 mL of ether, and dry at 105 for 1 hour: the weight of the cuprous oxide does not exceed 112 mg.

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

Residual solvents 467: meets the requirements.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3443

Phone Number : 1-301-816-8262