Croscarmellose Sodium IR Granules are pharmaceutical-grade immediate-release granules based on croscarmellose sodium, a cross-linked cellulose-based excipient used primarily for its disintegration functionality in oral solid formulations. Croscarmellose Sodium is the sodium salt of cross-linked, partly O-(carboxymethylated) cellulose and has CAS Number 74811-65-7.
The IR (Immediate-Release) format is intended for formulations where rapid availability of the incorporated material is required rather than delayed or sustained release. The performance of an IR granule system depends on its composition, granule characteristics, moisture, particle-size distribution and manufacturing process.
Croscarmellose Sodium is a cross-linked derivative of sodium carboxymethylcellulose. Its cross-linked structure provides water-uptake and swelling characteristics that support its function as a pharmaceutical superdisintegrant. It is used in tablets, capsules and granulated formulations.
Unlike a conventional low-molecular-weight chemical substance, Croscarmellose Sodium is a polymeric material. Therefore, a single fixed molecular weight should not be treated as a routine product specification.
Croscarmellose Sodium IR Granules provide the excipient in a controlled granulated format for formulation and manufacturing applications.
The granulated format can be useful where controlled physical characteristics are required for:
The exact particle-size distribution, bulk density, tapped density and flow characteristics should be controlled according to the actual product specification.
The objective of an immediate-release granule system is to support rapid and reproducible performance under the conditions specified for the finished formulation.
For Croscarmellose Sodium IR Granules, relevant physical characteristics can include:
Numerical values for these granule-specific properties should be published only when supported by the actual SDP specification or batch documentation.
Croscarmellose Sodium is primarily used as a superdisintegrant. Its hydrophilic and cross-linked structure allows it to interact with water and contribute to rapid breakup of appropriate solid formulations. Recent technical literature also describes its disintegration mechanism through swelling and wicking.
The material is used in both direct-compression and wet-granulation processes, as well as in tablet, capsule and granule formulations.
Croscarmellose Sodium has established compendial quality characteristics. The USP specification includes identification, pH, loss on drying, residue on ignition, degree of substitution, water-soluble material and settling volume.
The degree of substitution is specified at 0.60–0.85 on the dried basis, while loss on drying is NMT 10.0%. The pH of the specified aqueous dispersion is 5.0–7.0, and settling volume is 10.0–30.0 mL.
Croscarmellose Sodium IR Granules can be considered for pharmaceutical formulation development where a granulated immediate-release excipient format is required.
Potential applications include:
The appropriate grade and concentration should be established according to the formulation design and manufacturing process.
Particle size is an important consideration for granulated pharmaceutical materials. It can influence flow, blending, segregation and processing behavior.
For SDP's Croscarmellose Sodium IR Granules, the actual specification can include:
Particle Size: [SDP verified specification]
D10: [Verified value]
D50: [Verified value]
D90: [Verified value]
Similarly, bulk density, tapped density and flowability should be entered only when these characteristics are controlled for the particular product.
Moisture is an important quality consideration for Croscarmellose Sodium. The USP specification establishes loss on drying of NMT 10.0% under the specified test conditions.
For the finished IR granules, any separate moisture specification should be based on the actual approved product specification rather than automatically using the excipient monograph value.
Quality control of Croscarmellose Sodium includes identification and physicochemical characteristics such as:
The published USP information specifies total aerobic microbial count of NMT 1,000 CFU/g, total combined yeasts and molds of NMT 100 CFU/g, and absence of E. coli.
For the finished IR Granules, additional physical and performance testing may be applicable depending on the product specification.
Croscarmellose Sodium IR Granules may be used in:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |