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CELLETS® 263
- CAS Number
- 9004-34-6
- EC Number
- 232-674-9
- Chemical Name
- Cellulose, Microcrystalline, Cellulose Microcrystalline
CELLETS® 263 is highly spherical and narrow particle size for reproducible production process and content uniformity.
Properties
- Physical Form
- Pellets
- Solid
- Pharma and Nutraceuticals Functions
- Carrier
- Controlled Release Agent
Product families
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
- Oral
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
- Carriers & Bulking Agents
- Modified & Controlled Release
Other characteristics
- Brand
- CELLETS
- Synonyms
Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose
- Functions
- Carrier, Controlled Release Agent
- Dosage Form
- Capsules, Pellets, Sachets, Tablets
- Capsules
- Pellets
- Sachets
- Tablets
- Labeling Claims
- BSE-free, Naturally Derived, TSE-free
- BSE-free
- Naturally Derived
- TSE-free
- Certifications & Compliance
European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)
- Odor
- Odorless
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Appearance
White or nearly white or beige, hard and almost spherical particles
- Technology
- Pharmaceuticals & Nutraceuticals
- Ingredient Origin
- Natural Origin
- Non-Animal Origin
- Plant Origin
- Vegetable Origin
- 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.
- Certifications and Compliance
- European Pharmacopeia (Ph. Eur.)
- Japan Pharmacopeia (JP)
- National Formulary (NF)
- United States Pharmacopeia (USP)
Technical data
Table 1 of 3
11 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Particle Size | 212 – 300 | μm | Cellets Standard |
| Loss on Drying | max. 7.0 | % | Ph. EUR / USP/NF / JP / JPE |
| Bulk Density | 7.95 - 8.05 | g/cm³ | Ph. EUR / USP/NF / JP |
| Friability | 0 | % | Cellets Standard |
| Swelling Index | max. 2 | ml/g | Cellets Standard |
| Sphericity Degree (average) | max. 0.9 | — | Cellets Standard |
| pH Value | 5.0 - 7.5 | — | Ph. EUR / USP/NF / JP / JPE |
| Conductivity | max. 75 | μS/cm | Ph. EUR / USP/NF / JP / JPE |
| Ether Soluble Substances | max. 0.05 | % | Ph. EUR / USP/NF / JP / JPE |
| Water Soluble Substances | max. 0.25 | % | Ph. EUR / USP/NF / JP / JPE |
| Residue on Ignition | max 0.1 | % | Ph. EUR / USP/NF |
Table 2 of 3
4 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| TAMC | max. 1000 | CFU/g | Ph. EUR / USP/NF / JP / JPE |
| TYMC | max. 100 | CFU/g | Ph. EUR / USP/NF / JP / JPE |
| E. Coli, Ps. Aeruginosa,st. Aureus | Negative in 10 g sample | — | Ph. EUR / USP/NF / JP / JPE |
| Salmonella Species | Negative in 10 g sample | — | Ph. EUR / USP/NF / JP / JPE |
Table 3 of 3
1 row| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Heavy Metals | 10 | ppm | JP / JPE |
