Packaging and storage— Preserve in well-closed containers.

Labeling— The label states the nominal particle size range.

Identification— Transfer about 20g,accurately weighed,to a 200-mLvolumetric flask,add 160mLof 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.Awater slurry of the insoluble portion responds to Identificationtest Bunder Starch.[NOTE—Use the freshly prepared,clear filtrate for the Specific rotationtest.]

Specific rotation á781ñ: not less than +41and not more than +61,determined on a portion of the filtrate obtained in the Identificationtest,corresponding to not less than 62.5%and not more than 91.5%of sucrose (C12H22O11),calculated on the dried basis.

Microbial limits á61ñ— The Spheres meet the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,Staphylococcus aureus,and Pseudomonas aeruginosa,and the total aerobic microbial count does not exceed 100cfu per g.

Loss on drying á731ñ— Dry the Spheres at 105for 4hours:the material loses not more than 4.0%of its weight.

Residue on ignition á281ñ: not more than 0.25%,determined on a 2.0-g specimen ignited at a temperature of 700±25.

Particle size,Method Iá786ñ: 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 1of the general chapter.Not more than 10%passes the finer sieve size stated in the labeling.

Heavy metals,Method IIá231ñ: 5µg per g.

Organic volatile impurities,Method IVá467ñ: meets the requirements.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 3096

Phone Number:1-301-816-8330