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Micrococrystalline Cellulose (MCC)
Microcrystalline cellulose as
an indigestible dietary fiber
that has excellent sensory properties for use in food
applications partially
depolymerized cellulose prepared
by acid hydrolysis of purified
wood cellulose. It is designed
primarily for pharmaceutical
solid dosage formulations. Its
suitability for tableting
operations is demonstrated by
the number and variety of
functions. Among its many uses
are binder, filler,
disintegrant, flow aid,
lubricant and sugar coating
additive is a fine, white,
odorless, tasteless crystalline
powder. It consists of
free-flowing, no fibrous
particles that are relatively
free from both organic and
inorganic contaminants. It is
insoluble in water, organic
solvents, and dilute acids, but
partially soluble in dilute
alkali. MICROCORE MCC
meets all
specifications as per USP-NF /
BP / Ph. Eur. / JP / IP.
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SPECIFICATION FOR
MICROCRYSTALLINE CELLULOSE -
IP |
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Ref.: IP - 1996 |
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CHARACTERISTIC |
SPECIFICATION I01 |
SPECIFICATION 102 |
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A. CHEMICAL |
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Description |
Fine/Granular, White/almost
white, Odoourless powder |
Fine/Granular, White/almost
white, Odoourless powder |
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Solubility |
Complies |
Complies |
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Identification |
Complies |
Complies |
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pH |
5.0 - 7.5 |
5.0 - 7.5 |
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Starch & Dextrines |
Absent |
Absent |
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Organic Impurities |
Absent |
Absent |
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Water Soluble Substances, %
Max. |
0.2 |
0.2 |
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Arsenic, ppm Max. |
2 |
2 |
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Heavy metals, ppm Max. |
10 |
10 |
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Sulphated Ash, % Max. |
0.2 |
0.2 |
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Loss on drying, % Max. |
6 |
6 |
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Assay (on dried basis) %] |
97.0 - 102.0 |
97.0 - 102.0 |
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B. PHYSICAL |
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Bulk Density, gm/cc |
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Loose |
- |
- |
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Tapped |
- |
- |
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Sieve Analysis, Wt. % |
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(+) 60 Mesh |
NMT - 1 |
NMT - 8 |
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(+) 100 Mesh |
- |
- |
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(-) 200 Mesh |
NLT - 65 |
NMT - 55 |
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C. MICROBIAL LIMITS |
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Total Aerobic Microbial
count,CFU per gram Max. |
1000 |
1000 |
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Total combined Molds &
YeastsCount, CFU per gram
Max |
100 |
100 |
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Escherichia coli |
Absent |
Absent |
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Salmonella Species |
Absent |
Absent |
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Staphylococcus aureus |
Absent |
Absent |
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Pseudomonas aeruginosa |
Absent |
Absent |
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Note : 1. NLT = Not less
Than; NMT = Not More Than. |
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2. Bulk Density &
Sieve Analysis and Microbial
Limits are as per
consignee's requirements |
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3 Customer
Reference if any: |
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SPECIFICATION OF
MICROCRYSTALLINE CELLULOSE (USP28
NF-23) |
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CHARACTERISTIC |
SPECIFICATION |
SPECIFICATION |
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USP-101 |
USP-102 |
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A. CHEMICAL |
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Identification A,B |
Complies |
Complies |
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PH Value |
5.0 - 7.0 |
5.0 - 7.0 |
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Conductivity, uS per CM MAX. |
75 |
75 |
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Organic Volatile Impurities |
Absent |
Absent |
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Water-soluble Substances %
max |
0.2 |
0.2 |
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Ether-soluble substances %
Max |
0.05 |
0.05 |
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Heavy Metals, PPM Max |
10 |
10 |
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Residue on Ignition, % Max |
0.05 |
0.05 |
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Loss on drying, % Max |
7 |
7 |
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B. PHYSICAL |
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Bulk Density, gm/cc |
--- |
--- |
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Loose |
--- |
--- |
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Tap |
--- |
--- |
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Sieve Analysis, Wt.% |
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Wt.% (+) 60 Mesh |
NMT-1 |
NMT-8 |
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Wt.% (+) 100 Mesh |
--- |
--- |
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Wt.% (-) 200 Mesh |
NLT-65 |
NMT-45 |
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C . MICROBIAL LIMITS |
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Total Aerobic Microbial
Count, CFU per gram Max |
1000 |
1000 |
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Total combined Molds &
Yeasts Count, CFU per gram
Max |
100 |
100 |
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Escherichia Coli |
Absent |
Absent |
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Salmonella species |
Absent |
Absent |
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Staphylococcus aureus |
Absent |
Absent |
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Pseudomonas aeruginosa |
Absent |
Absent |
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Note: 1. NMT - Not more
than, NLT - Not Less than |
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2. Bulk Density &
Sieve Analysis are as per
consignee's requirements |
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