Microcrystalline Cellulose
Microcrystalline
Cellulose
Microcrystalline
Cellulose
RITECEL® MCC (Microcrystalline Cellulose) is a multi-functional excipient extensively employed in the pharmaceutical industry for solid dosage forms. Its versatility as a binder, filler, diluent, and disintegrant makes it an indispensable component in direct compression, dry granulation, and wet granulation processes.
As a binder, RITECEL® MCC enhances tablet strength and integrity, while as a filler and diluent, it contributes to the desired size and weight of tablets. Its disintegrant properties aid in rapid dissolution and drug release. With excellent flowability and compressibility, RITECEL® MCC ensures uniform blending and distribution of ingredients, resulting in consistent tablet formulations.
Its compatibility and ease of processing make it a preferred choice for pharmaceutical manufacturers seeking efficient and high-quality solid dosage production.
Product Data Sheet
MCC Standard Types
RITECEL® MCC is a multi-functional excipient widely used in solid dosage for the pharmaceutical industry
as a binder/filler/diluent/disintegrate in direct compression, dry granulation, or wet granulation process.
| Grade | Particle Size Distribution | LOD** % |
Bulk Density* g/ml |
||||
|---|---|---|---|---|---|---|---|
| Retention Method (Sieve Analysis)* | By Laser Diffraction Method* | ||||||
| 60# % | 200# % | D10 (µm) | D50 (µm) | D90 (µm) | |||
| RITECEL® 105 |
400 # NMT 1 | 1.0-5.0 | 0.20-0.30 | ||||
| RITECEL® 101 |
NMT 1.0 | NMT 30 | NMT 30 | 40-60 | NLT 80 | 3.0-5.0 | 0.27-0.34 |
| RITECEL® 103 |
NMT 1.0 | NMT 30 | NMT 30 | 40-60 | NLT 80 | 1.0-3.0 | 0.26-0.34 |
| RITECEL® 301 |
NMT 1.0 | NMT 30 | NMT 30 | 40-60 | NLT 80 | 3.0-5.0 | 0.34-0.45 |
| RITECEL® 102 |
NMT 8.0 | NLT 45 | NMT 45 | 70-100 | NLT 140 | 3.0-5.0 | 0.26-0.34 |
| RITECEL® 112 |
NMT 8.0 | NLT 45 | NMT 45 | 70-100 | NLT 140 | 0.0-1.5 | 0.26-0.34 |
| RITECEL® 302 |
NMT 8.0 | NLT 45 | 0.28-0.45 | ||||
| RITECEL® 12 |
40# NMT 1 | 325# NLT 70 | NMT 50 | 100-140 | NLT 200 | 3.0-5.0 | 0.26-0.40 |
| RITECEL® 112 |
40# NLT 10 | 100# NLT 50 | NMT 70 | 150-200 | NLT 260 | 3.0-5.0 | 0.31-0.39 |
NMT: Not More ThanNLT: Not Less Than*: Customize as per customer requirements.**: More restrictive than a compendium.
Unique Features of RITECEL® MCC
Angle
of Repose
of Repose
Customized
Bulk Density
Bulk Density
Excellent
Flowability
Flowability
Better
Compressibility
Compressibility
Technical Specification of MCC
| Parameters | Specification |
|---|---|
| Colour | White |
| Solubility | Practically insoluble in water, dilute acid and most of organic solvents, Slightly soluble in dilute NaOH solution |
| Identification A (USP/BP), B (EP),1 (JP) | Have to correspond as USP/NF, JP,Ph.Eur.,BP |
| Identification A (EP) | Have to correspond as Ph. Eur. |
| Identification B (USP/BP), 3(JP), C (EP) (Degree of Polymerization) | NMT 350 as USP/NF,JP,Ph.Eur.,BP |
| Identification 2 (JP) | Have to correspond as JP |
| Solubility (coppertetramine solution) |
Have to correspond as Ph.Eur., BP |
| pH | 5.0-7.5 asUSP/NF,JP,Ph.Eur.,BP |
| Conductivity | NMT 75 µS.cm-1as USP/NF,JP,Ph.Eur.,BP |
| Parameters | Specification |
|---|---|
| Water- Soluble Substance | NMT 0.25% as USP/NF,JP,Ph.Eur.,BP |
| Ether - Soluble Solution | NMT 0.05% as USP/NF,JP,Ph.Eur.,BP |
| Loss on Drying | NMT 7.0% as USP/NF,JP,Ph.Eur.,BP |
| Heavy Metals | NMT 10 PPM as USP/NF,JP,Ph.Eur.,BP |
| Residue on Ignition/Sulphated Ash |
NMT 0.1% as USP/NF,JP,Ph.Eur.,BP |
| Residue on Ignition/Sulphated Ash |
NMT 0.1% as USP/NF,JP,Ph.Eur.,BP |
| Organic volatile Impurities |
To comply the tests as per method IV. (USP) |
| Assay (Dried) | 97.0 - 102.0(IP) |
| Arsenic | NMT 2 PPM as IP |
| Starch & Dextrin | Should comply the test as IP |
| Organic Impurities | Should comply the test as IP |
Benefits
- Strong Dry Binder
- Excellent compressibility that allows for high tablet hardness
at low compression pressure. - Facilities low tablet friability
- Wet granulation, promotes rapid even wetting
and uniform rapid drying.
- High Dilution potential
- Promotes tablet disintegration through fast water uptake
- Has inherent lubrication, anti-adherent and absorbent properties.
- Superior physical and chemical stability.
Application Guide on each type of
RITECEL® MCC
| Type | Main Application | |
|---|---|---|
| RITECEL® 105 |
Very fine grade, which gives a pleasant mouth feeling, masks bitter tastes, and supports flavors. |
|
| RITECEL® 101 |
Fine standard MCC grade, especially suited for wet granulation, roller compaction, and spheronization. Very high compact ability |
|
| RITECEL® 103 |
Same quality as grade 101, but has a very low moisture content (< 1.5%) for processing water-sensitive actives. |
|
| RITECEL® 301 |
Same quality as grade 101, but increased bulk density and improved flow properties. |
|
| RITECEL® 102 |
Medium size standard MCC grade, suited for the majority of directly compressible actives. Combines good flow and high compact ability. |
|
| RITECEL® 112 |
Same quality as grade 102, but has a very low moisture content (< 1.5%) for processing water-sensitive actives. |
|
| RITECEL® 302 |
Same quality as grade 302, but increased bulk density and improved flow properties. Especially suited for high-speed tableting and processing high-density actives. Grater tablet weight, uniformity. |
|
| RITECEL® 12 |
Coarse grade MCC combines good compact ability but high binding capacity with outstanding flow. Provides good content uniformity at low weight variation- even when used with low concentrations of fine actives. |
|
| RITECEL® 200 |
Large size MCC grade with excellent flow properties for a variety of direct compression formulations. |
|
Packing Details
HDPE / Paper Bags
25Kg / 20Kg
HDPE / Corrugated Drums
25Kg
Container
20 Ft. (Approx. Wt.) : 11,000 Kg
40 Ft. (Approx. Wt.) : 21,000 Kg