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Send EmailCroscarmellose Sodium, Croscarmellose Cellulose, Croscarmellose Sodium Silica Dioxide, Cross-linked Sodium CMC, 74811-65-7
CROSCARMELLOSE SODIUM – KROSKARMELOZ SODYUM
CAS Number: 74811-65-7
EC Number (EINECS): Not assigned (polymer)
Molecular Formula: Variable (C₈H₁₆O₈)ₙ
Molecular Weight: 240.21 g/mol (monomer unit)
E Number: E468 (Food additive)
Chemical Class: Cross-linked cellulose derivative (sodium carboxymethyl cellulose)
SECTION 1: CHEMICAL IDENTITY AND DEFINITION
| Parameter | Information |
|---|---|
| Chemical Name | Croscarmellose Sodium |
| Other Names | Cross-linked Sodium Carboxymethyl Cellulose, Cross-linked Sodium CMC, Cross-linked Cellulose Gum, Croscarmellose, Croscarmellose Cellulose, Croscarmellose Sodium Silica Dioxide |
| Chemical Formula | Variable (C₈H₁₆O₈)ₙ |
| Molecular Weight | Variable (polymer) |
| CAS Number | 74811-65-7 |
| EC Number (EINECS) | Not assigned (polymer) |
| E Number | E468 (Food additive) |
| Chemical Class | Cross-linked cellulose derivative (sodium carboxymethyl cellulose) |
| Appearance | White to off-white, free-flowing powder |
| Odor | Odorless |
| Taste | Tasteless |
| Physical State (20°C) | Solid (powder) |
| Hygroscopicity | Moderate |
SECTION 2: PHYSICAL PROPERTIES
| Property | Value |
|---|---|
| Appearance | White to off-white, free-flowing powder |
| Odor | Odorless |
| Taste | Tasteless |
| Molecular Weight | Variable (polymer) |
| Monomer Unit Formula | C₈H₁₆O₈ |
| Monomer Unit Molecular Weight | 240.21 g/mol |
| Bulk Density | ~0.48 g/cm³ |
| Tapped Density | ~0.68 g/cm³ |
| pH (1% suspension) | 5.0 – 7.0 |
| Melting Point | > 205 °C (decomposes) |
| Solubility in Water | Insoluble (swells rapidly to form gel) |
| Solubility in Acetone | Practically insoluble |
| Solubility in Ethanol | Practically insoluble |
| Solubility in Toluene | Practically insoluble |
| Swelling Volume | High (rapid water uptake) |
| Particle Size | 100 – 200 mesh |
| Loss on Drying | ≤ 10.0% |
SECTION 3: CHEMICAL PROPERTIES
| Property | Information |
|---|---|
| Chemical Formula | Variable (C₈H₁₆O₈)ₙ |
| Chemical Class | Cross-linked cellulose derivative (sodium carboxymethyl cellulose) |
| Functional Groups | Carboxymethyl (-CH₂COONa), hydroxyl (-OH) |
| Structure | Cross-linked cellulose polymer with carboxymethyl groups |
| Degree of Substitution | 0.6 – 0.9 |
| Cross-linking | Inter-polymer cross-linking |
| pH (1% suspension) | 5.0 – 7.0 |
| Stability | Stable under normal storage conditions |
| Incompatible Materials | Strong oxidizing agents, strong acids, strong bases |
Chemical Structure:
Cellulose Polymer with Carboxymethyl Groups
|
CH₂COONa
|
Cellulose-O-CH₂COONa
|
Cross-linked polymer network
(Croscarmellose Sodium)
SECTION 4: FUNCTIONAL PROPERTIES
| Property | Description |
|---|---|
| Primary Function | Superdisintegrant in pharmaceutical tablets |
| Secondary Function | Stabilizer, emulsifier, thickener |
| Mechanism | Rapid water uptake and swelling (wicking effect) |
| Swelling Capacity | High; expands rapidly in contact with water |
| Disintegration Time | Fast (seconds to minutes) |
| Wicking Effect | Capillary action draws water into tablet matrix |
| Gel Formation | Forms gel upon hydration |
| pH Independence | Effective across a wide pH range |
SECTION 5: PHARMACEUTICAL APPLICATIONS
| Application | Function |
|---|---|
| Tablet Disintegrant | Superdisintegrant for immediate-release tablets |
| Capsule Disintegrant | Disintegrant in hard gelatin capsules |
| Soluble APIs | Enhances dissolution of poorly soluble drugs |
| Bioavailability Enhancement | Improves API bioavailability |
| Effervescent Tablets | Disintegrant in effervescent formulations |
| Sustained Release | Used in sustained release formulations |
| Orodispersible Tablets | Fast disintegration in mouth |
| Granulation | Used in wet and dry granulation |
| Suspensions | Stabilizer in liquid suspensions |
SECTION 6: FOOD INDUSTRY APPLICATIONS (E468)
| Application | Function |
|---|---|
| Food Additive | Emulsifier, stabilizer (E468) |
| Texture Improvement | Improves food texture and stability |
| Sauces and Dressings | Stabilizer and thickener |
| Dairy Products | Texture improvement |
| Bakery Products | Dough conditioner |
| Beverages | Suspension stabilizer |
SECTION 7: COSMETIC AND PERSONAL CARE APPLICATIONS
| Application | Function |
|---|---|
| Lotions and Creams | Thickener and stabilizer |
| Shampoos | Thickener and stabilizer |
| Cosmetic Formulations | Viscosity enhancer |
| Skin Care Products | Texture improvement |
SECTION 8: AGRICULTURAL APPLICATIONS
| Application | Function |
|---|---|
| Pesticide Formulations | Dispersant and stabilizer |
| Herbicide Formulations | Dispersant and stabilizer |
| Fertilizer Coatings | Binder and release agent |
SECTION 9: QUALITY SPECIFICATIONS (PHARMACEUTICAL GRADE)
9.1. USP Specifications
| Parameter | Specification (USP / Ph. Eur.) |
|---|---|
| Appearance | White to off-white, free-flowing powder |
| Identification | Positive (Cellulose tests) |
| pH (1% suspension) | 5.0 – 7.0 |
| Loss on Drying | ≤ 10.0% |
| Residue on Ignition | 14.0 – 28.0% |
| Sodium Content | 6.0 – 9.0% |
| Degree of Substitution | 0.6 – 0.9 |
| Water Swelling | ≥ 5.0 mL/g |
| Heavy Metals (as Pb) | ≤ 10 ppm |
| Lead (Pb) | ≤ 2 ppm |
| Arsenic (As) | ≤ 3 ppm |
| Mercury (Hg) | ≤ 1 ppm |
| Cadmium (Cd) | ≤ 1 ppm |
| Microbial Limits | TAMC ≤ 1,000 CFU/g, TYMC ≤ 100 CFU/g |
9.2. Typical Disintegration Performance
| Parameter | Performance |
|---|---|
| Concentration in Tablet | 1-5% |
| Disintegration Time | 1-5 minutes |
| Swell Time | Seconds |
| Water Uptake | Rapid |
SECTION 10: COMPARISON WITH OTHER DISINTEGRANTS
| Property | Croscarmellose Sodium | Sodium Starch Glycolate | Crospovidone |
|---|---|---|---|
| Disintegration Mechanism | Swelling + Wicking | Swelling | Wicking |
| Swelling Capacity | High | Very High | Moderate |
| Disintegration Time | Fast | Very Fast | Fast |
| pH Independence | Yes | Yes | Yes |
| Compression | Good | Good | Excellent |
| Cost | Moderate | Low | High |
| Recommended Use | 1-5% | 2-8% | 1-5% |
SECTION 11: STORAGE AND SHELF LIFE
| Parameter | Information |
|---|---|
| Storage Conditions | Cool (15-25°C), dry, well-ventilated area |
| Container Requirements | Tightly closed, original packaging |
| Protect From | Moisture, strong oxidizing agents, strong acids, strong bases |
| Shelf Life | 24-48 months (unopened original packaging) |
| Stability Note | Stable; store in dry conditions |
SECTION 12: PACKAGING OPTIONS
| Packaging Type | Quantity | Material |
|---|---|---|
| PE-lined kraft paper bag | 25 kg | Kraft paper + PE |
| Plastic pail | 20-25 kg | HDPE |
| Fiber drum | 25-50 kg | HDPE + PE |
| Aluminum foil bag | 1-5 kg | Laminated aluminum |
SECTION 13: SAFETY AND HEALTH INFORMATION
GHS Classification (Bulk Powder)
| Hazard Class | Category |
|---|---|
| Not classified as hazardous | - |
Hazard Statements
| Code | Statement |
|---|---|
| None | Not classified as hazardous |
Precautionary Statements
| Code | Statement |
|---|---|
| P261 | Avoid breathing dust |
| P280 | Wear protective gloves/eye protection |
| P305+P351+P338 | IF IN EYES: Rinse cautiously with water for several minutes; remove contact lenses if present and easy to do; continue rinsing |
SECTION 14: TOXICOLOGICAL INFORMATION
| Parameter | Value |
|---|---|
| Oral LD50 (Rat) | > 5,000 mg/kg |
| Skin Irritation | Non-irritant |
| Eye Irritation | Mild irritant |
| Skin Sensitization | Non-sensitizer |
| Carcinogenicity | Not classified |
| Mutagenicity | Negative in standard tests |
| GRAS Status | Generally recognized as safe |
| ADI (Acceptable Daily Intake) | Not specified (JECFA) |
SECTION 15: FIRST AID MEASURES
| Exposure Route | Action |
|---|---|
| Inhalation | Move to fresh air. If respiratory irritation persists, seek medical attention. |
| Skin Contact | Wash with plenty of soap and water. |
| Eye Contact | Rinse immediately with plenty of water for at least 15 minutes. Seek medical attention. |
| Ingestion | Rinse mouth. Drink plenty of water. Seek medical attention. |
SECTION 16: REGULATORY STATUS
| Region / Authority | Status |
|---|---|
| European Union | E468 (approved food additive) |
| USA (FDA) | Approved as excipient and food additive |
| Turkey | Approved (Turkish Food Codex and Pharmaceutical regulations) |
| JECFA (FAO/WHO) | Approved; ADI: Not specified |
| USP | Monograph available |
| Ph. Eur. | Monograph available |
| NF | Monograph available |
SECTION 17: TRANSPORT INFORMATION
| Parameter | Information |
|---|---|
| UN Number | Not regulated (not dangerous goods) |
| Hazard Class | Not applicable |
| Packing Group | Not applicable |
| ADR/RID | Not regulated |
| IMDG Code | Not regulated |
| IATA (Air) | Not regulated |
| Marine Pollutant | No |
SECTION 18: FIRE-FIGHTING MEASURES
| Parameter | Information |
|---|---|
| Fire Hazard | Combustible organic powder |
| Suitable Extinguishing Media | Water spray (mist), CO₂, dry chemical powder |
| Specific Hazards | When heated, emits CO, CO₂ |
| Decomposition Products | CO, CO₂ |
| Protective Equipment | Self-contained breathing apparatus (SCBA), full protective clothing |
SECTION 19: ACCIDENTAL SPILLAGE AND CLEANUP
| Parameter | Information |
|---|---|
| Personal Protection | Nitrile gloves, protective goggles, dust mask (N95) |
| Cleaning Methods | Sweep or vacuum; avoid dust generation |
| Environmental Precautions | Prevent entry into drains, soil, and surface waters |
| Waste Disposal | According to local regulations; landfilling at licensed facilities |
SECTION 20: OTHER NAMES AND SYNONYMS
| Type | Name |
|---|---|
| Turkish Names | Kroskarmeloz Sodyum, Çapraz Bağlı Sodyum Karboksimetil Selüloz |
| English Names | Croscarmellose Sodium, Cross-linked Sodium Carboxymethyl Cellulose, Cross-linked Sodium CMC, Cross-linked Cellulose Gum |
| Pharmaceutical Names | Croscarmellose Sodium USP, Croscarmellose Sodium BP, Croscarmellose Sodium EP, Croscarmellose Sodium NF |
| Abbreviation | CCS |
| E Number | E468 |
| CAS Number | 74811-65-7 |
SECTION 21: SUMMARY AND CRITICAL NOTES
Product Summary
| Parameter | Value |
|---|---|
| Product | Croscarmellose Sodium |
| CAS Number | 74811-65-7 |
| E Number | E468 |
| Appearance | White to off-white, free-flowing powder |
| pH (1% suspension) | 5.0 – 7.0 |
| Primary Function | Superdisintegrant in tablets, emulsifier |
Critical Notes
-
Superdisintegrant: Croscarmellose sodium is a highly effective superdisintegrant for pharmaceutical tablets.
-
Rapid Swelling: Swells rapidly in water; provides fast disintegration (1-5 minutes).
-
Wicking Effect: Works through wicking (capillary action) and swelling.
-
pH Independent: Effective across a wide pH range (2-12).
-
Low Concentration: Effective at low concentrations (1-5% in tablets).
-
High Purity: Pharmaceutical grade available with USP, Ph. Eur., and NF monographs.
-
Food Additive: Approved as E468 food additive (emulsifier and stabilizer).
-
Inert: Chemically inert; compatible with most active ingredients.
-
Non-Hygroscopic: Moderate hygroscopicity; stable under normal storage.
-
Regulatory Status: Approved in EU (E468), FDA, and Turkish Food Codex.
IMPORTANT DECLARATION: This Technical Data Sheet (TDS) is for informational purposes only and has been prepared based on available technical data. The user is responsible for determining the product's suitability for their specific application and for complying with all local, national, and international regulations. For complete safety, storage, use, transport, waste, and regulatory compliance information, refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier.
