Croscarmellose Sodium Superdisintegrant for Pharmaceutical Tablets | Fast Swelling, Low Use Level 0.5-5% | USP/EP/JP Compliant

Our Croscarmellose Sodium is a high-purity superdisintegrant designed for oral solid dosage forms including tablets, capsules, and granules. It is an internally cross-linked sodium carboxymethylcellulose that is insoluble in water but rapidly swells to 4-8 times its original volume upon contact with aqueous media . This unique fibrous structure provides excellent water wicking capability and capillary action, resulting in superior tablet disintegration and enhanced drug dissolution . Conforms to USP-NF, EP, JP, and ChP pharmacopoeias with CDE registration F20209990136 . Typical use level: 0.5-5.0% w/w (2% for direct compression, 3% for wet granulation) . Suitable for direct compression, wet granulation (intra- or extra-granular), roller compaction, and capsule formulations

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Product Detail

Pharmaceutical Grade Croscarmellose Sodium (CCS)

Product Overview

Croscarmellose Sodium is an internally cross-linked sodium carboxymethylcellulose, specifically designed for use as a superdisintegrant in pharmaceutical formulations . Unlike conventional disintegrants, it provides exceptional disintegrating properties at low concentrations, ensuring rapid tablet breakdown and enhanced drug dissolution for improved bioavailability .

Product Identity:

Chemical Name: Croscarmellose Sodium
CAS Number: 74811-65-7
CDE Registration No.: F20209990136
Pharmacopoeia Compliance: ChP, USP-NF, EP, JP, BP
EC No.: 629-739-2
Synonyms: Cross-linked Carboxymethylcellulose Sodium, CCNa, Sodium Croscarmellose, E468

Key Features & Benefits

1. Superior Disintegration Mechanism

Dual-action disintegration: Combines capillary action (wicking) with rapid swelling
Swells to 4-8 times its original volume upon contact with water
Fibrous structure provides excellent water absorption capabilities
Creates mechanical expansion that rapidly breaks apart tablets

2. Low Use Level – High Efficiency

Effective at concentrations as low as 0.5-5.0% w/w
Typical usage: 2% for direct compression, 3% for wet granulation
Cost-effective solution for formulation development

3. Formulation Flexibility

Suitable for all tableting processes: direct compression, wet granulation, roller compaction
In wet granulation, can be used intra-granularly, extra-granularly, or divided between both phases
Compatible with capsule formulations (10-25% usage)

4. Excellent Physical Properties

Appearance: White to off-white, free-flowing powder
Degree of Substitution: 0.60 – 0.85
Settling Volume: 10.0 – 30.0 ml
pH (1% solution): 5.0 – 7.0
Loss on Drying: ≤10.0%
Residue on Ignition: 14.0% – 28.0%
Water Soluble Matter: ≤10.0%
Heavy Metals: ≤10 ppm

5. API Compatibility & Stability

Does not contain peroxides – ensures better stability for oxidation-sensitive APIs
No negative impact on tablet hardness or friability
Disintegration performance remains consistent over time
Non-GMO, allergen-free