Packaging and storage— Preserve in well-closed containers.

Labeling— The label states the nominal particle size range.

Identification— 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. A water slurry of the insoluble portion responds to Identification test B under Starch. [NOTE—Use the freshly prepared, clear filtrate for the Specific rotation test.]

Specific rotation 781: not less than +41 and not more than +61, determined on a portion of the filtrate obtained in the Identification test, corresponding to not less than 62.5% and not more than 91.5% of sucrose (C12H22O11), calculated on the dried basis.

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 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, Method I 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.

Heavy metals, Method II 231: 5 µg per g.

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

Residual solvents 467: meets the requirements.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3445

Phone Number : 1-301-816-8262