(as USP , NF: Official Monography)


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 on starch.

They consist of approximately spherical particles of a labeled nominal size range.

They may contain color additives permitted by the federal "Food and Drug Administration for use in drugs"

Packaging and storage - Preserve in well-closed containers.

Labeling - The label states the nominal particle size range.

Identification and Specific rotation - 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. Separate the solubilized sucrose from the insoluble starch component by vacuum filtration through fine filter paper until the filtrate is clear. Use the insoluble portion for the Identification test, and use the freshly prepared, clear filtrate for the Specific rotation test.

Identification - A water slurry of the insoluble portion responds to Identification test B under Starch.

Specific rotation (781): not less than +41° and not more than +61°, determined on a portion of the filtrate, corresponding to not less than 62.5% and not more than 91.5% of sucrose (C12H22 O11), calculated on the dried basis.

Heavy metals, Method II (231): <= 5 ppm.

Microbial limits (61) - 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 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 (see Powder Fineness (811) - Test a portion of the Spheres in accordance with the procedure for coarse powders.

Not less than 90.0% of it passes the larger nominal standard sieve; 100.0% passes the next larger standard sieve; not more than 10.0% passes the smaller nominal sieve. [NOTE - Use a mechanical sieve-shaking unit that employs both rotary motion and tapping, in order to ensure reliability of this test.].

"Organic volatile impurities, Method IV (467): meets the requirements"

1. Consistent particle size distribution. Low oversize and undersize.
2. Uniform, spherical seeds.
3. National Formulary status. Meets the specifications of the USP, NF and PH EUR for Sugar Spheres.
4. Minimum twinning.
5. Low dust.
6. Consistent bulk density.
7. Low friability (cracking & chipping).
8. High production capacity. Excellent availability and delivery service.
9. Shelf life: Sugar Spheres have a shelf life of at least 24 months after purchase, if stored in a cool and dry place.