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Systematic Nomenclature and Commercial Synonyms:
Chemical Description: Cross-linked sodium carboxymethylcellulose
INCI Name: Sodium Croscarmellose
Common Names: Croscarmellose sodium, Crosscarmellose sodium, Modified cellulose gum
Pharmaceutical Grades: Ac-Di-Sol® (DuPont), Primellose® (DFE Pharma), Vivasol® (JRS Pharma)
CAS Registry Number: 74811-65-7
EC Number: 278-928-2
INS Number: 468
UNII: M28OL1HH48
Molecular Architecture:
Chemical Structure: Cross-linked polymer of carboxymethylcellulose sodium salt
Degree of Substitution (DS): 0.60-0.85 (carboxymethyl groups per anhydroglucose unit)
Degree of Cross-linking: 10-20% (cross-linked monomer units)
Molecular Weight: Not applicable (insoluble cross-linked polymer)
Particle Morphology: Fibrous, porous particles
Extended Physical Characterization:
Croscarmellose sodium appears as a white to off-white, odorless, fibrous powder. The cross-linked structure creates a three-dimensional network that swells extensively in water without dissolving, generating tremendous swelling pressure that facilitates tablet disintegration.
Physical Property Data:
Appearance: White to off-white fibrous powder
Odor: Odorless
Taste: Tasteless
Particle Size: Typical D₉₀ <400 μm, D₅₀ 50-150 μm
Bulk Density: 0.3-0.5 g/cm³
Tapped Density: 0.4-0.6 g/cm³
True Density: 1.5-1.7 g/cm³
Moisture Content: ≤10% (equilibrium at 50% RH)
pH (1% slurry): 5.0-7.0
Swelling Volume: 40-80 mL/g in water
Water Uptake: 5-15 g/g (depends on grade and conditions)
Solubility: Insoluble in water, organic solvents; swells without dissolution
Flowability: Poor to fair (Carr Index >25)
Chemical Behavior and Functional Properties:
Disintegration Mechanism:
Rapid water uptake: Capillary action draws water into tablet matrix
Extensive swelling: Up to 60-fold volume increase generates internal pressure
Network expansion: Swollen particles push tablet apart
Maintenance of porosity: Does not form viscous gel that would retard disintegration
Key Performance Characteristics:
Disintegration time: Typically <1 minute for immediate release tablets
Swelling force: High (generates 50-100 N/cm²)
Lubricant sensitivity: Low (unlike starch-based disintegrants)
Drug binding: Minimal (does not interact with most APIs)
Stability: Stable under normal storage conditions
Optimization Parameters:
Concentration: 1-5% w/w in tablet formulation (typically 2-4%)
Particle size: Fine grades for faster disintegration, coarse for better flow
Incorporation method: Intragranular, extragranular, or both
Compression force: Works effectively over wide compression range
Industrial Applications:
Pharmaceutical Tablet Formulations:
Immediate release tablets: Primary disintegrant (2-5% w/w)
Orally disintegrating tablets (ODT): Key component (5-10% w/w)
Bilayer tablets: In active layer for controlled release
Capsule formulations: In capsule contents to promote dispersion
Chewable tablets: Aids disintegration in mouth
Physical Testing:
Swelling Test: Volume increase in water or simulated gastric fluid
Hydration Capacity: Water uptake measurement
Disintegration Efficiency: Using model tablet formulations
Particle Size Distribution: Laser diffraction or sieve analysis
Microscopy: SEM for particle morphology
Chemical Analysis:
Degree of Substitution: Titrimetric method after acid hydrolysis
Sodium Content: Atomic absorption spectroscopy
Residual Solvents: GC for ethanol, isopropanol
Microbial Limits: According to pharmacopoeial requirements
Pharmacopoeial Specifications (USP/NF):
Identification: IR spectroscopy matches reference spectrum
pH: 5.0-7.0 (1 in 100 dispersion)
Sodium content: 10.0-12.0% (on dried basis)
Degree of substitution: 0.60-0.85
Heavy metals: ≤0.001%
Loss on drying: ≤10.0%
SAFETY INFORMATION ABOUT CROSCARMELLOSE SODIUM
First aid measures:
Description of first aid measures:
General advice:
Consult a physician.
Show this safety data sheet to the doctor in attendance.
Move out of dangerous area:
If inhaled:
If breathed in, move person into fresh air.
If not breathing, give artificial respiration.
Consult a physician.
In case of skin contact:
Take off contaminated clothing and shoes immediately.
Wash off with soap and plenty of water.
Consult a physician.
In case of eye contact:
Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Continue rinsing eyes during transport to hospital.
If swallowed:
Do NOT induce vomiting.
Never give anything by mouth to an unconscious person.
Rinse mouth with water.
Consult a physician.
Firefighting measures:
Extinguishing media:
Suitable extinguishing media:
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Special hazards arising from the substance or mixture
Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas
Advice for firefighters:
Wear self-contained breathing apparatus for firefighting if necessary.
Accidental release measures:
Personal precautions, protective equipment and emergency procedures
Use personal protective equipment.
Avoid breathing vapours, mist or gas.
Evacuate personnel to safe areas.
Environmental precautions:
Prevent further leakage or spillage if safe to do so.
Do not let product enter drains.
Discharge into the environment must be avoided.
Methods and materials for containment and cleaning up:
Soak up with inert absorbent material and dispose of as hazardous waste.
Keep in suitable, closed containers for disposal.
Handling and storage:
Precautions for safe handling:
Avoid inhalation of vapour or mist.
Conditions for safe storage, including any incompatibilities:
Keep container tightly closed in a dry and well-ventilated place.
Containers which are opened must be carefully resealed and kept upright to prevent leakage.
Storage class (TRGS 510): 8A: Combustible, corrosive hazardous materials
Exposure controls/personal protection:
Control parameters:
Components with workplace control parameters
Contains no substances with occupational exposure limit values.
Exposure controls:
Appropriate engineering controls:
Handle in accordance with good industrial hygiene and safety practice.
Wash hands before breaks and at the end of workday.
Personal protective equipment:
Eye/face protection:
Tightly fitting safety goggles.
Faceshield (8-inch minimum).
Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
Skin protection:
Handle with gloves.
Gloves must be inspected prior to use.
Use proper glove
removal technique (without touching glove's outer surface) to avoid skin contact with this product.
Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices.
Wash and dry hands.
Full contact:
Material: Nitrile rubber
Minimum layer thickness: 0.11 mm
Break through time: 480 min
Material tested:Dermatril (KCL 740 / Aldrich Z677272, Size M)
Splash contact
Material: Nitrile rubber
Minimum layer thickness: 0.11 mm
Break through time: 480 min
Material tested:Dermatril (KCL 740 / Aldrich Z677272, Size M)
It should not be construed as offering an approval for any specific use scenario.
Body Protection:
Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Respiratory protection:
Where risk assessment shows air-purifying respirators are appropriate use a fullface respirator with multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls.
If the respirator is the sole means of protection, use a full-face supplied air respirator.
Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).
Control of environmental exposure
Prevent further leakage or spillage if safe to do so.
Do not let product enter drains.
Discharge into the environment must be avoided.
Stability and reactivity:
Chemical stability:
Stable under recommended storage conditions.
Incompatible materials:
Strong oxidizing agents:
Hazardous decomposition products:
Hazardous decomposition products formed under fire conditions.
Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas.
Disposal considerations:
Waste treatment methods:
Product:
Offer surplus and non-recyclable solutions to a licensed disposal company.
Contact a licensed professional waste disposal service to dispose of this material.
Contaminated packaging:
Dispose of as unused product
