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
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 |
| 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. |
| 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 Aeruginosa, 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 |
Note: 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™ 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:
| Application |
Binder |
Compression Agent |
Flow Aid |
Disintegration and Dissolution Aid |
Diluent |
Reduces Friability |
Facilitates Addition of Granulation Solution |
Carrier for Drugs in Liquid Form |
Oil Adsorption |
Vegetable Extract Carrier |
Facilitates Extrusion |
| 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 Adsorption |
|
|
|
|
|
|
|
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 |
|
|
|
Comparative Characteristics of most commonly employed SANCEL™ Grades of Microcrystalline Cellulose
| Differential Parameters |
SANCEL™ 101 |
SANCEL™ 102 |
SANCEL™ 112 |
SANCEL™ 200 |
| Average Particle Size (Micron) |
50 |
100 |
160 |
180 |
| Weight retained on 60 Mesh (%) |
NMT 1 |
NMT 8 |
NLT 10 |
NLT 10 |
| Weight retained on 100 Mesh (%) |
– |
– |
NLT 40 |
NLT 50 |
| Weight retained on 200 Mesh (%) |
NMT 30 |
NLT 45 |
– |
– |
| Loss on Drying |
NMT 7 |
NMT 7 |
NMT 7 |
NMT 7 |
NMT – Not More Than NLT – Not Less Than
