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

DescriptionCellets 1000
AppearanceWhite, nearly white or beige, hard and almost spherical particlesCellets Standard
SolubilityInsoluble in water, ehtanol, acetone and toluene, diluted in acids Ph.Eur. and sodium hydroxide solution (50 g/l)Ph.Eur.
OdorOdorlessPh.Eur., JPE
Physical parameters
Particle size distribution1000-1400 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)≥ 0.90Cellets Standard
Friability (%)0Cellets Standard
Swelling index (ml/g)≤ 2Cellets Standard
Chemical parameters
Identification infrared absorptionpassedPh.Eur., USP/NF, JP
Identification zinc chloride testpassedPh.Eur., USP/NF, JP, JPE
Degree of polymerization≤ 350Ph.Eur., USP/NF, JP
pH value5.0 – 7.5Ph.Eur., USP/NF, JP, JPE
Conductivity (µS/cm)≤ 75Ph.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)≤ 10JP, JPE
Sulfated ash / Residue on ignition [%] determined on 1 g)≤ 0.1Ph.Eur., USP/NF
Sulfated ash / Residue on ignition [%] determined on 2 g)≤ 0.1JP, JPE
Microbiological parameters
Total aerobic microbial count≤ 1,000 CFU/gPh.Eur., USP/NF, JP, JPE
Fungi / moulds and yeasts≤ 100 CFU/gPh.Eur., USP/NF, JP, JPE
E. coli Ps. aerugin. St. aureusabsence in 1 g samplePh.Eur., USP/NF, JP, JPE
Samonella speciesabsence in 10 g samplePh.Eur., USP/NF, JP, JPE
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