Croscarmellose Sodium (IP/BP/USP/EP) is a high-performance superdisintegrant used in tablet and capsule formulations to promote rapid breakup after administration. It is the sodium salt of a cross-linked, partly O-carboxymethylated cellulose, and the Indian Pharmacopoeia draft describes it as a white or grayishwhite powder.
It is mainly used to improve disintegration and support faster drug release in direct compression and wet granulation formulations. The draft IP text lists a pH range of 5.0 to 7.0, degree of substitution of 0.60 to 0.85, settling volume of 10.0 to 30.0 mL, sulphated ash of 14.0 to 28.0 percent, and loss on drying not more than 10.0.
Key Benefits
- Excellent swelling and wicking action for fast disintegration.
- Suitable for direct compression and wet granulation.
- White to grayish-white powder with good formulation
compatibility. - Helps improve dissolution profile of solid dosage forms.
Typical Applications:
- Tablets
- Capsules
- Fast disintegrating formulations
Typical Quality Parameters:
- pH: 5.0 – 7.0
- Degree of substitution: 0.60 – 0.85
- Settling volume: 10.0 – 30.0 mL
- Loss on drying: NMT 10.0%
- Sulphated ash: 14.0 – 28.0%
