Microcrystalline Cellulose

Microcrystalline cellulose is a pharmaceutical excipient specially made for tablet production. The product is a highly porous particle, very easy to deform, with a large drug holding capacity, good dry adhesion and disintegration properties, and can be pressed into very hard tablets.

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Microcrystalline Cellulose (MCC)

Microcrystalline cellulose is a pharmaceutical excipient specially made for tablet production. The product is a highly porous particle, very easy to deform, with a large drug holding capacity, good dry adhesion and disintegration properties, and can be pressed into very hard tablets.

 

 

MCC(Microcrystalline Cellulose)

 Our product is white or off-white powder or granular powder, odorless and tasteless, insoluble in water, ethanol, ether, dilute sulfuric acid, organic solvents and oil, etc.

 

Product Parameters

Item 

Index

PH

5.0-7.5

Loss on drying

< 7.0%

Burning residue

≤ 0.1%

Dissolved matter in water

≤ 0.2%

Dissolved matter in ether

≤ 0.05%

Starch test

Passed

Chloride

≤ 0.03%

Heavy metals

≤ 10 ppm

Arsenic salts

≤ 2 ppm

Total bacteria count

≤ 1000 parts /gram

Fungus count

≤ 100 parts /gram

Escherichia coli test

Negative

Conductivity

≤ 75 us/cm

Complies with the 2020 edition (Part 4) of the Chinese Pharmacopoeia; Registration number: F20190000304/F20209990409

Product Specifications

Specification

PH-101

PH-102

Average particle size(μm)

50

100

Moisture

≤0.5%

≤3.5%

Screening rate

120 mesh residue ≤   5.0%, 200 mesh pass rate ≥50.0%

 

Product Physicochemical characteristics

 

  • 01
    Physical properties

    Microcrystalline cellulose is a white, odorless crystalline powder with good compressibility and tabletability. It can form a stable gel structure and has high water absorption and expansion.

  • 02
    Chemical properties

    It is an inert, non-ionic cellulose derivative that is insoluble in water, dilute acid and most organic solvents, but can be hydrolyzed under strong acid conditions. Its molecular structure is stable and shows good chemical stability in a wide pH range.

Environmental protection and safety

Biodegradable: As a plant fiber-based product, MCC is completely biodegradable and environmentally friendly.

High safety: It is considered safe for use in food and medicine, and is not absorbed by the human body, but naturally excreted through the digestive tract.

 

Application

Microcrystalline Cellulose (MCC) is a crystalline powder obtained by chemically treating purified cellulose, which has a wide range of applications.

 

 

  • 01
    Tablet - Fillers, adhesives and disintegrants

    Microcrystalline cellulose has good fluidity and can be easily mixed with other excipients. Adding an appropriate amount of this product can improve the dissolution of the drug in the tablet.

  • 02
    Food additive - Anti-caking agents, stabilizers and thickeners

    MCC can prevent powdered or granular foods from clumping, keeping the product loose and easy to use. Due to its good water absorption and swelling properties, MCC can increase the viscosity of food, improve texture, and help maintain the stability of food structure.

  • 03
    Skin Care Products

    Microcrystalline cellulose can increase the viscosity of skin care products, improve the texture of the product, make it thicker and easier to spread. At the same time, it can also help maintain the stability of product formulas and prevent ingredient separation.

Reference dosage

Tablet binder/diluent (wet granulation)

5%-20%

Tablet binder/diluent (dry compression)

5%-20%

Tablet disintegrant

5%-15%

Tablet glidant

5%-20%

Capsule diluent

10%-30%

 

Production Process

The production process of microcrystalline cellulose mainly includes the following steps:

1.‌Raw material pretreatment‌: First, select suitable natural plants as raw materials, such as rice husks, vegetable pulp, bagasse, corn cobs, etc. Then pretreat these raw materials to extract high-purity cellulose.

2.‌Acid hydrolysis method‌: Under acidic conditions, the β-1,4 glycosidic bonds in the cellulose structure are cleaved, the amorphous region is gradually removed, and the cellulose molecules are degraded to the limit degree of polymerization (15 to 375) to form microcrystalline cellulose. Commonly used acids include hydrochloric acid and sulfuric acid, among which the microcrystalline cellulose prepared by hydrochloric acid has a higher degree of polymerization and thermal stability.

3.‌Enzymatic hydrolysis method‌: This is a new preparation method that uses cellulase to break the molecular chains in the amorphous region of the cellulose molecule under specific conditions to form cellulose molecules mainly composed of crystalline regions, thereby obtaining microcrystalline cellulose. The enzymatic hydrolysis method has the advantages of less chemical use and green and environmentally friendly preparation process.

4.‌Mechanical grinding method‌: The cellulose raw material is ground into microcrystalline cellulose by mechanical grinding. This method is relatively simple, but the yield is low‌.

5.‌Drying‌: The prepared microcrystalline cellulose needs to be dried to remove moisture and obtain the final product‌.

 

Package

 

 

Packaged in a cardboard barrel lined with a polyethylene bag, net weight: 25.0kg/barrel.

Keep away from moisture!

Use as soon as possible after opening.

 

 

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