CELLETS® 1000
1000-1400 µm
CELLETS® are highly spherical starter pellets consisting of 100 % microcrystalline cellulose. They act as neutral starter cores and as multiparticulate carriers in extended release formulations of highly active or low concentrated API. Chemical inertness, high friability, high sphericity and smooth surface properties are key advantages for easy and reliable drug delivery formulations.
product information
Description | CELLETS® 1000 | |
Appearance | White, nearly white or beige, hard and almost spherical particles | Cellets Standard |
Solubility | Insoluble in water, ehtanol, acetone and toluene, diluted in acids Ph.Eur. and sodium hydroxide solution (50 g/l) | Ph.Eur. |
Odor | Odorless | Ph.Eur., JPE |
Physical parameters | ||
Particle size distribution | 1000-1400 µm (≥ 85 %) | Cellets Standard |
Loss on drying | ≤ 7.0 % | Ph.Eur., USP/NF, JP, JPE |
Bulk density (g/cm3) | 0.80 ± 5 % (for information only) | Ph.Eur., USP/NF, JP |
Sphericity degree (average) | ≥ 0.90 | Cellets Standard |
Friability (%) | 0 | Cellets Standard |
Swelling index (ml/g) | ≤ 2 | Cellets Standard |
Chemical parameters | ||
Identification infrared absorption | passed | Ph.Eur., USP/NF, JP |
Identification zinc chloride test | passed | Ph.Eur., USP/NF, JP, JPE |
Degree of polymerization | ≤ 350 | Ph.Eur., USP/NF, JP |
pH value | 5.0 – 7.5 | Ph.Eur., USP/NF, JP, JPE |
Conductivity (µS/cm) | ≤ 75 | Ph.Eur., USP/NF, JP, JPE |
Ether soluble substances | ≤ 0.05 % | Ph.Eur., USP/NF, JP, JPE |
Water soluble substances | ≤ 0.25 % | Ph.Eur., USP/NF, JP, JPE |
Heavy metals (ppm) | ≤ 10 | JP, JPE |
Sulfated ash / Residue on ignition [%] determined on 1 g) | ≤ 0.1 | Ph.Eur., USP/NF |
Sulfated ash / Residue on ignition [%] determined on 2 g) | ≤ 0.1 | JP, JPE |
Microbiological parameters | ||
Total aerobic microbial count | ≤ 1,000 CFU/g | Ph.Eur., USP/NF, JP, JPE |
Fungi / moulds and yeasts | ≤ 100 CFU/g | Ph.Eur., USP/NF, JP, JPE |
E. coli Ps. aerugin. St. aureus | absence in 1 g sample | Ph.Eur., USP/NF, JP, JPE |
Samonella species | absence in 10 g sample | Ph.Eur., USP/NF, JP, JPE |
or