Listing ID #3803813
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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
APPLICATIONS
This product meets the requirements for Residual Solvents in the United States Pharmacopeia 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 ® 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.
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.
| 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 | ||
| 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 |
| Container | Palletized | Non-Palletized |
|---|---|---|
| 20 Ft. (Approx Wt.) | 10,000 Kg | 12,000 Kg |
| 40 Ft. (Approx Wt.) | 20,000 Kg | 24,000 Kg |
| 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 |
| 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 |
| Type | Size |
| HDPE Bags | 25 Kg |
| HDPE Bags | 20 Kg |
| Paper Bags | 25 Kg |
| Paper Bags | 20 Kg |
| FIBC | 300 Kg |
Nature of Business
Manufacturer / Exporter / Supplier / Retailer
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