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Active Pharmaceuticals

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  • Specifications
  • Product Description
  • Product Usage
  • COA

Product Name:Cellulose microcrystalline
Synonyms:AVICEL PH;AVICEL PH 101(R);AVICEL PH 102;AVICEL PH 105(R);AVICEL(R);”AVICEL(R)”;AVICEL SF;AVIRIN
CAS:9004-34-6
MF:H2
MW:2.01588
EINECS:232-674-9
Appearance:White Powder
Product Categories:Nutritional

Microcrystalline cellulose is a term for refined wood pulp and is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production. The most common form is used in vitamin supplements or tablets. It is also used in plaque assays for counting viruses, as an alternative to carboxymethylcellulose.

Microcrystalline cellulose (MCC) is pure partially depolymerized cellulose synthesized from α-cellulose precursor. The MCC can be synthesized by different processes such as reactive extrusion, enzyme mediated, steam explosion and acid hydrolysis. The later process can be done using mineral acids such as H2SO4, HCl and HBr as well as ionic liquids. The role of these reagents is to destroy the amorphous regions remaining the crystalline domains. The degree of polymerization is typically less than 400. The MCC particles with size lower than 5 µm must not be more than 10%. The MCC is a valuable additive in pharmaceutical, food, cosmetic and other industries. Different properties of MCC are measured to qualify its suitability to such utilization, namely particle size, density, compressibility index, angle of repose, powder porosity, hydration swelling capacity, moisture sorption capacity, moisture content, crystallinity index, crystallite size and mechanical properties such as hardness and tensile strength.

1. As a disintegrant, stable emulsifier, etc., it is widely used in medicine and health, food and beverage, light chemical industry
2. Used as adsorbent, suspending agent, diluent, disintegrant
3. Can be used as a sustained release agent for medicines

Items
Standards
Results
Physical Analysis
Appearance
Fine Powder
Conforms
Color
White
Conforms
Odor
Characteristic
Conforms
Mesh Size
100% through 80 mesh size
Conforms
General Analysis
Identification
Identical to R.S. sample
Conforms
Test Method
2 Years
Conforms
Extract Solvents
Water
Conforms
Loss on Drying (g/100g)
≤5.0
2.32%
Ash(g/100g)
≤5.0
3.18%
Chemical Analysis
Pesticides Residue (mg/kg)
<0.05
Conforms
Residual Solvent
<0.05%
Conforms
Residual Radiation
Negative
Conforms
Lead(Pb) (mg/kg)
<3.0
Conforms
Arsenic(As) (mg/kg)
<2.0
Conforms
Cadmium(Cd) (mg/kg)
<1.0
Conforms
Mercury(Hg) (mg/kg)
<0.1
Conforms
Microbiological Analysis
Total Plate Count(cfu/g)
≤1,000
Conforms
Molds and Yeast (cfu/g)
≤100
Conforms
Coliforms (cfu/g)
Negative
Conforms
Salmonella(/25g)
Negative
Conforms

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