Croscarmellose Sodium Excipient Manufacturer India | Swapnroop Pharma

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Croscarmellose Sodium Excipient Manufacturer India | Swapnroop Pharma

Croscarmellose Sodium is a chemically modified, cross-linked cellulose derivative widely used as a pharmaceutical excipient in oral solid dosage forms. It is primarily used as a superdisintegrant to promote rapid breakup of tablets and facilitate the release of the active pharmaceutical ingredient.

Croscarmellose Sodium combines swelling and wicking mechanisms, allowing it to absorb water and expand rapidly within a tablet matrix. This makes it particularly valuable in conventional tablets, immediate-release formulations, and orally disintegrating dosage forms.

Croscarmellose Sodium Excipient Overview

Croscarmellose Sodium is the sodium salt of internally cross-linked carboxymethylcellulose. The cross-linking reduces its solubility while maintaining its ability to absorb water and swell.

It is generally supplied as a white to off-white, free-flowing powder and is used at relatively low concentrations in tablet formulations.

Chemical and Pharmaceutical Profile

  • Product Name: Croscarmellose Sodium
  • **CAS No.: 74811-65-7
  • Chemical Name: Cross-linked sodium carboxymethylcellulose
  • Category: Pharmaceutical Excipient
  • Excipient Function: Superdisintegrant
  • Source: Cellulose-derived
  • Physical Form: White to off-white powder
  • Water Interaction: Rapid water uptake and swelling
  • Primary Applications: Tablets, capsules, orally disintegrating tablets

Pharmaceutical Applications

Croscarmellose Sodium is commonly used in:

  • Immediate-release tablets
  • Conventional tablets
  • Orally disintegrating tablets
  • Capsules
  • Direct-compression formulations
  • Wet-granulated tablets
  • Dry-granulated formulations
  • Fast-disintegrating dosage forms

Functional Benefits

Croscarmellose Sodium provides:

  • Rapid tablet disintegration
  • High water absorption
  • Strong swelling capacity
  • Effective wicking action
  • Improved drug-release performance
  • Suitability for direct compression
  • Compatibility with various tablet formulations
  • Effective performance at relatively low concentrations

Quality and Analytical Testing

Pharmaceutical-grade Croscarmellose Sodium should be evaluated according to the applicable pharmacopoeial and product-specific requirements. Typical testing may include:

  • Identification
  • Appearance
  • Degree of substitution
  • Sodium content
  • pH
  • Loss on drying
  • Water-soluble matter
  • Viscosity, where applicable
  • Particle-size distribution
  • Microbial limits
  • Heavy metals / elemental impurities, where applicable

Exact acceptance limits should be confirmed against the applicable USP/NF, Ph. Eur., BP, IP, or manufacturer-specific specification.

Croscarmellose Sodium Excipient Manufacturer India

Swapnroop Pharma provides Croscarmellose Sodium for pharmaceutical formulation applications with emphasis on consistent quality, grade-specific specifications, batch control, and documentation support.

Croscarmellose Sodium can be supplied for applications requiring rapid tablet disintegration, improved water uptake, and efficient drug-release characteristics.

Packaging and Storage

Croscarmellose Sodium should be stored in tightly closed packaging in a cool, dry and well-ventilated environment. Protect from moisture, excessive heat, direct sunlight, and contamination.

Because its performance depends on water uptake and swelling, exposure to excessive moisture should be avoided during storage.

Documentation

Documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product Specification
  • Technical Data Sheet
  • Batch documentation
  • Regulatory documentation
  • Packaging and shipping documentation

Why Choose Croscarmellose Sodium from Swapnroop Pharma?

  • Pharmaceutical excipient-focused supply
  • Consistent quality
  • Grade-specific quality control
  • Suitable for tablet and capsule formulations
  • Effective superdisintegrant functionality
  • Batch documentation support
  • Bulk supply capability
  • Professional pharmaceutical industry service

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
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