CELLETS® 780 is smallest size starter core(<200 μm) for the production of micropellets and MUPS tablet formulation incl.ODT.

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

Functions: Carrier, Controlled Release Agent

Dosage Form: Pellets, Tablets

Labeling Claims: BSE-free, Naturally Derived, TSE-free

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Synonyms: Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose

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Identification & Functionality

Pharma & Nutraceuticals Functions
CAS No.
9004-34-6
EC No.
232-674-9

Features & Benefits

Product Highlights
  • Produced of pure MCC
  • Highly spherical and narrow particle size for reproducible production and content uniformity.
  • Shorter and more stable layering process with higher yield due to lower firability non solubility in comparision with standard starter core.

Applications & Uses

Dosage Form
Applications
  • These are used as neutral starter cores for controlled release formulations.
  • Used in capsule and tablet formulations.
     

Properties

Physical Form
Odor
Odorless
Appearance
White or nearly white or beige, hard and almost spherical particles
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Particle Size710 – 850μmCellets Standard
Loss on Dryingmax. 7.0%Ph. EUR / USP/NF / JP / JPE
Bulk Density7.95 - 8.05g/cm³Ph. EUR / USP/NF / JP
Friability0%Cellets Standard
Swelling Indexmax. 2ml/gCellets Standard
Sphericity Degree (average)max. 0.9Cellets Standard
pH Value5.0 - 7.5Ph. EUR / USP/NF / JP / JPE
Conductivitymax. 75μS/cmPh. EUR / USP/NF / JP / JPE
Ether Soluble Substancesmax. 0.05%Ph. EUR / USP/NF / JP / JPE
Water Soluble Substancesmax. 0.25%Ph. EUR / USP/NF / JP / JPE
Residue on Ignitionmax 0.1%Ph. EUR / USP/NF
Microbiological Values
ValueUnitsTest Method / Conditions
TAMCmax. 1000CFU/gPh. EUR / USP/NF / JP / JPE
TYMCmax. 100CFU/gPh. EUR / USP/NF / JP / JPE
E. Coli, Ps. Aeruginosa,st. AureusNegative in 10 g samplePh. EUR / USP/NF / JP / JPE
Salmonella SpeciesNegative in 10 g samplePh. EUR / USP/NF / JP / JPE
Composition
ValueUnitsTest Method / Conditions
Heavy Metals10ppmJP / JPE

Regulatory & Compliance