U.S. PHARMACOPEIA

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Confectioner's Sugar
» Confectioner's Sugar is Sucrose ground together with corn starch to a fine powder. It contains not less than 95.0 percent of sucrose (C12H22O11), calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Identification, Specific rotation, Chloride, Calcium, Sulfate, and Heavy metals— Transfer about 20 g, accurately weighed, to a 100-mL volumetric flask, add 80 mL of water, shake to dissolve the sucrose, then add water to volume, and mix. Separate the solubilized sucrose from the insoluble starch component by filtration until the filtrate is sparkling clear. Use the insoluble portion for the Identification test, and use the freshly prepared, clear filtrate for the other tests that follow.
Identification— A water slurry of the insoluble portion responds to Identification test B under Starch.
Specific rotation 781 : not less than +62.6, determined on a portion of the filtrate, corresponding to not less than 95.0% of C12H22O11, calculated on the dried basis.
Chloride 221— A 10-mL portion of the filtrate shows no more chloride than corresponds to 0.40 mL of 0.020 N hydrochloric acid (0.014%).
Calcium 191 —To 5 mL of the filtrate add 5 mL of water and 1 mL of ammonium oxalate TS: the solution remains clear for not less than 1 minute.
Sulfate 221— A 25-mL portion of the filtrate shows no more sulfate than corresponds to 0.30 mL of 0.020 N sulfuric acid (0.006%).
Heavy metals 231— To 20 mL of the filtrate add 4 mL of water and 1 mL of 0.1 N hydrochloric acid: the limit is 5 ppm.
Microbial limits 61— It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Loss on drying 731— Dry it at 105 for 4 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.08%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 3444
Pharmacopeial Forum : Volume No. 31(4) Page 1147
Phone Number : 1-301-816-8262