SANCEL ® Microcrystalline cellulose is widely used in pharmaceuticals, primarily as a binder/diluent in oral tablet and capsule formulations where it is used in both wet-granulation and direct-compression processes. In addition to its use as a binder/diluent, SANCEL ® Microcrystalline Cellulose also has some lubricant and disintegrant properties that make it useful in tableting.
SANCEL ® Microcrystalline Cellulose is purified, partly depolymerized cellulose with shorter, crystalline polymer chains. Its strong binding performance makes SANCEL ® MCC one of the most commonly used fillers and binders in drug formulations across the world.
SANCEL ® Microcrystalline Cellulose Powder is a white fine powder free from all foreign matter. The supplies are made normally in 25Kgs, laminated HDPE bag with liner. The material has a shelf life of five year. The packing can be done as per customer’s requirement as well.
ADVANTAGES
- Chemical Purity / Low Reactivity
- Excellent Binding Capability
- Filler
- Better Disintegrating Property
- Greater Flowability
- Rapid wicking action permits fast addition of granulation fluid
- Highly Absorbent
APPLICATIONS
- Excipient in Tableting
- It is Multifunctional Excipient
- It is used as binder / diluent in tableting
Unique Features of SANCEL® MCC
Angle of Repose
Customized Bulk Density
Excellent Flowability
Better Compressibility
Pharmacopeial Specifications:
| Parameters | I.P. | B.P. / Ph.Eur. | U.S.P. – N.F. | ||
| Appearance | White or almost White, Fine or Granular Powder | ||||
| Odour | Odourless | N.A. | N.A. | ||
| Solubility | N.A. | Comply | N.A. | ||
| Identification A+B+C | Comply | A+B | A+B | ||
| pH Value | 5.0 to 7.5 | 5.0 to 7.5 | 5.0 to 7.5 | ||
| Loss on Drying, % NMT | 6 | 7 | 7 | ||
| Sulphated Ash, % NMT | 0.20 | 0.10 | 0.10 | ||
| Assay, % | 97 – 102 | N.A. | N.A. | ||
| Conductivity, µS / cm, not exceed than water by | N.A. | 75 | 75 | ||
| Water Soluble substances, % NMT | 0.20 | 0.25 | 0.25 | ||
| Ether Soluble Substances, %NMT | N.A. | 0.05 | 0.05 | ||
| Heavy Metals, PPM NMT | 10 | 10 | 10 | ||
| Arsenic, PPM, NMT | 2 | N.A. | N.A. | ||
| Starch and Dextrins | Absent | N.A. | N.A. | ||
| Microbiology Limits | |||||
| Total Aerobic Microbial Count, CFU/g, NMT | 1,000 | 1,000 | 1,000 | ||
| Total Yeast and Mold Count, CFU/g, NMT | 100 | 100 | 100 | ||
| Pseudomonas Aerugionos, per g | Absent | Absent | Absent | ||
| Escherichia Coli, per g | Absent | Absent | Absent | ||
| Staphylococcus Aureus,per g | Absent | Absent | Absent | ||
| Salmonella Sp.,per 10 g | Absent | Absent | Absent | ||
This product meets the requirements for Residual Solvents in the United States Pharmacopeia <467> and complies with the ICH Guide Q3C for Residual Solvents.
Storage Conditions: Store Protected from Light and Moisture.
Re-evaluation Date: Four (4) years from date of manufacture, if storage conditions stated above are observed.
– SANCEL ® 101 – SANCEL ® 102
– SANCEL ® 103 – SANCEL ® 105
– SANCEL ® 112 – SANCEL ® 115
– SANCEL ® 200 – SANCEL ® 200 LM
– SANCEL ® 301 – SANCEL ® 302
* We can also tailor attributes to complement desired performance
| Grades of SANCEL ® Microcrystalline Cellulose | ||||
| Differential Parameters | SANCEL ® 101 | SANCEL ® 102 | SANCEL ® 112 | SANCEL ® 200 |
| Average Particle Size (Mircon) | 50 | 100 | 100 | 180 |
| Weight retained on 60 # (%) | NMT 1 | NMT 8 | NMT 8 | NLT 10 |
| Weight retained on 100 # (%) | – | – | – | NLT 50 |
| Weight retained on 200 # (%) | NMT 30 | NLT 45 | NLT 45 | – |
| Loss on Drying | NMT 7 | NMT 7 | NMT 1.5 | NMT 7 |
NMT – Not More Than NLT – Not Less Than
Available Packaging Type
| Type | Size |
| HDPE Bags | 25 Kg |
| HDPE Bags | 20 Kg |
| Paper Bags | 25 Kg |
| Paper Bags | 20 Kg |
| FIBC | 300 Kg |
*Our standard packaging is in 25 kg Bags. We can also customize packaging as per customers request at additional cost.
| Container | Palletized | Non-Palletized |
|---|---|---|
| 20 Ft. (Approx Wt.) | 10,000 Kg | 12,000 Kg |
| 40 Ft. (Approx Wt.) | 20,000 Kg | 24,000 Kg |
SANCEL ® is the preferred excipient for use in tablets, capsules, granules, pellets & spheres, as it enhances the adsorption and absorption of drugs for solid dosage formulations. It is able to function in the following applications
| Binder | Compressino Agent | Flow Aid | Disintegration and Dissolution Aid | Diluent | Reduces Friability | Falicitates Addition of granulation Solution | Carrier for Drugs in LIquid Form | Oil Adsorption | Vegetable Extract Carrier | Facilitates Extrution | |
| Tablets by Direct Compaction | Y | Y | Y | Y | Y | Y | |||||
| Tablets by Wet Granulation | Y | Y | Y | Y | Y | ||||||
| Capsules (Automatic Machine) | Y | Y | Y | ||||||||
| Capsules (Semi Automatic Machine) | Y | Y | |||||||||
| Granules | Y | Y | Y | Y | Y | Y | Y | Y | Y | ||
| Pellets and Spheres | Y | Y | Y | ||||||||
| API Adsorptino | Y | Y | Y | ||||||||
| API Absorption | Y | Y |
Recommended Type of SANCEL ® for Each Manufacturing Process
The range of recommended levels of use for all applications of various types of SANCEL ® products, either in wet granulation or in direct compression, is usually between 10% to 90%.
SANCEL ® is the world wide preferred excipient for use in tablets manufactured by wet granulation and direct compression.
| Types of SANCEL ® Microcrystalline Cellulose | ||||
| SANCEL ® 101 | SANCEL ® 102 | SANCEL ® 112 | SANCEL ® 200 | |
| Wet Granulation | Y | Y | ||
| Direct Compaction | Y | Y | Y | |
| Poor Flowing API | Y | Y | ||
| API Adsorption/Absorption | Y | Y | Y | Y |
| Vegetable Extract Adsorption/Absorption | Y | Y | Y | Y |
| Capsules (Automatic Filling | Y | |||
| Capsules (Semi Automatic Filling) | Y | Y | ||
| Pellet & Spheronization | Y | |||