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Microcrystalline Cellulose (MCC)

CAS Number
9004-34-6
EC Number
232-674-9
Chemical Name
Cellulose

Industrial Use only (No Human Consumption)

Identification

CASE Ingredients Functions
EmulsifierRheology ModifierThickener

Product families

CASE Ingredients — Additives
  • Functional Additives
  • Rheology Modifiers & Stabilizers

Other characteristics

Functions
Emulsifier, Rheology Modifier, Thickener
Note

More restrictive than compendium NLT = Not Less Than NMT = Not More Than

Soluble In
Copper Tetrammine Hydroxide
Technology
CASE Ingredients
Regulatory Statement

This product meets the requirements for Residual Solvents in the United States Pharmacopeia <467> and complies with the ICH Guide Q3C for Residual Solvents.

Product Shelf-life / Re-evaluation Date

Store at ambient conditions. Keep containers sealed; material is very hygroscopic. Four (4) years from date of manufacture, if storage conditions stated above are observed. R&M International recommends that after the above re-evaluation date, the customer perform the loss on drying. Typical Degree Polymerization range for microcrystalline cellulose is 100 to 300.

Technical data

Table 1 of 3

10 rows
CharacteristicValueUnitMethod
Loss on Drying3.0 - 5.0%3600
Loose Bulk Density0.28 - 0.33g/cc3611
Identification (NF, Ph.Eur. A+2)Passes—3014
Degree of PolymerizationNMT. 350—3647
pH5.5 - 7.0—3005
ConductivityNMT. 75μS/cm3005
Residue on IgnitionNMT. 0.05%3601
Water Soluble SubstancesNMT. 12.5mg/5g3002
Ether Soluble SubstancesNMT. 5.0mg/10g3646
Heavy MetalsNMT. 0.001%3602

Table 2 of 3

7 rows
CharacteristicValueUnitMethod
Total Aerobic Microbial CountNMT. 100CFU/g3605
Total Yeast and Mold CountNMT. 20CFU/g3606
Pseudomonas aeruginosaAbsent in 10gram3607
Escherichia coliAbsent in 10gram3608
Staphylococcus aureusAbsent in 10gram3609
Salmonella speciesAbsent in 10gram3610
Coliform speciesAbsent in 10gram3620

Table 3 of 3

5 rows
CharacteristicValueUnitMethod
D1015-55—1045
D5080-140—1045
D90170-283—1045
Particle Size (Air Jet, 60 mesh (250 microns))NMT. 8wt.%3604
Particle Size (Air Jet, 200 mesh (75 microns))NLT. 45wt.%3604

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