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.

Available Grades of MCC

– 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

Comparative Characteristics of SANCEL ® MCC
  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

Packaging Details

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

Technical Product Data Sheets & Samples are available on request

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