Brief definition
MCC(microcrystalline cellulose pellets are made of only microcrystalline cellulose (MCC). As critical pharmaceutic adjuvant, MCC pellets are used as cores to be coated in the manufacture of controlled-release or sustained-release formulations. It enables greater accuracy and consistency in drug layering and coating.
Appearance : White or kind of white near circular pellets.
Application: As critical pharmaceutic sugar-free core for the manufacture of sustained & controlled-release pellets.
Chemical specifications:
MCC 100% & Purified water;
Polymerization: not more than 350;
Water: Between 4.0% and 5.5%;
Bulk density: About 0.80 g/cm3 ± 5%;
Conductivity: less than 75µS/cm;
PH: Between 5.0 and 7.5;
Dissolved in ether: residue is not more than 0.05%;
Dissolved in water: residue is not more than 0.25%;
Heavy metal: not more than 10ppm;
Residue on ignition: not more than 0.1%;
Loss of drying: weight loss is not more than 6%;
Microorganism limits:
Aerobic bacteria is not more than 1000 cuf per g
Moulds and yeasts is not more than 100 cuf per g
No E.coli
Characteristics
1.Sugar-free core;
2.High physico-chemical stability, so it is of benefit to the stability of finished products;
3.High hardness and low friability;
4.Insoluble in water and organic solvent, low osmotic pressure and non-effect drug release;
5.Porous structure promote to absorb more active component;
Specifications:
Product ID | Granule-diameter (µm) |
P1 | 200-355 |
P2 | 355 -500 |
P3 | 500 -710 |
P4 | 710-1000 |
Storage:Preserve in tight containers,keep it in dry place
Validity: 2 years.
COA attached to each delivery.
pharmaceutical microcrystalline cellulose Pellets