Sugar Spheres
» Sugar Spheres contain not less than 62.5 percent and not more than 91.5 percent of sucrose (C12H22O11), calculated on the dried basis, the remainder consisting chiefly of starch. They consist of approximately spherical particles of a labeled nominal size range. They may contain color additives permitted by the FDA for use in drugs.
Packaging and storage— Preserve in well-closed containers.
Labeling— The label states the nominal particle size range.
Identification— A 1:10 suspension gives a violet to deep blue color with iodine TS.
Specific rotation 781: not less than +41 and not more than +61, corresponding to not less than 62.5% and not more than 91.5% of sucrose (C12H22O11), calculated on the dried basis.
Test solution— Transfer about 20 g accurately weighed, to a 200-mL volumetric flask, add 160 mL of water, shake to dissolve the sucrose, add water to volume, and mix. Pass the solubilized sucrose solution by vacuum filtration through fine filter paper.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 The Spheres meet the requirements of the tests for absence of Salmonella species, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa, and the total aerobic microbial count does not exceed 100 cfu per g.
Loss on drying 731 Dry the Spheres at 105 for 4 hours: the material loses not more than 4.0% of its weight.
Residue on ignition 281: not more than 0.25%, determined on a 2.0-g specimen ignited at a temperature of 700 ± 25.
Particle size 786: not less than 90% of it passes the coarser sieve size stated in the labeling; all of it passes the next coarser sieve size listed in Table 1 of the general chapter. Not more than 10% passes the finer sieve size stated in the labeling.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, B.A.
Scientist
1-301-816-8335
(EM105) Excipient Monographs 1
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1365
Pharmacopeial Forum: Volume No. 32(6) Page 1777
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.