Croscarmellose Sodium Granules are pharmaceutical-grade granulated material based on croscarmellose sodium, a cross-linked form of sodium carboxymethylcellulose used as a functional excipient in oral solid formulations. Croscarmellose sodium is recognized as a pharmaceutical excipient and is commonly used for its disintegration functionality in solid dosage-form development. Its CAS Number is 74811-65-7.
Croscarmellose Sodium Granules are designed for applications where controlled material handling, consistent granule characteristics and reproducible formulation performance are important. Compared with a conventional powder presentation, a granulated material can provide a different physical form for processing, depending on the manufacturing process and intended formulation application. The actual particle-size distribution, moisture level, density and flow characteristics should be controlled according to the product's approved specification.
Croscarmellose Sodium is the sodium salt of a cross-linked, partly O-(carboxymethylated) cellulose. FDA's substance registration system identifies it as a polymer and recognizes croscarmellose sodium as a defined pharmaceutical ingredient.
The material is also known as cross-linked carboxymethylcellulose sodium, cross-linked sodium CMC, and modified cellulose gum. PubChem lists CAS Number 74811-65-7 for Croscarmellose Sodium.
Because croscarmellose sodium is a polymeric excipient, it does not have a single fixed molecular weight comparable to a discrete small molecule. Therefore, molecular-weight information should not be artificially entered into a product page unless a specific manufacturer specification defines an appropriate value.
Croscarmellose sodium is primarily used as a disintegrant excipient in oral solid formulations. Its functional characteristics make it useful in formulation development where rapid and consistent breakup of a solid dosage form is required.
FDA documentation lists croscarmellose sodium among excipients used in approved oral solid formulations, and FDA's excipient guidance also includes croscarmellose sodium among commonly evaluated excipients.
Croscarmellose Sodium Granules can be considered for pharmaceutical formulation applications where a granulated excipient format is preferred for processing or manufacturing. The suitability of the material depends on the formulation process, granulation method, particle-size characteristics, moisture level and other material attributes.
Important physical characteristics for a granulated material may include:
These parameters should be reported only when they are actually controlled and tested for the particular Croscarmellose Sodium Granules product.
Croscarmellose Sodium has established compendial quality characteristics. Published USP information specifies identification tests, pH, loss on drying, degree of substitution, water-soluble material, settling volume and other quality attributes.
The USP specification gives a pH range of 5.0–7.0 for the specified aqueous dispersion and a loss on drying of not more than 10.0% under the stated test conditions.
The degree of substitution is specified as 0.60–0.85 on the dried basis, which is an important chemical characteristic of croscarmellose sodium.
The published USP information also specifies a settling volume of 10.0–30.0 mL under the stated test procedure.
Croscarmellose Sodium Granules may be considered for use in the development and manufacture of oral solid formulations where croscarmellose sodium is selected as a functional excipient.
Potential formulation applications include:
The actual concentration and processing method should be established through formulation development and validated manufacturing processes rather than assumed from a generic product description.
For a granulated product, particle-size distribution can influence handling, blending, segregation, flow and downstream processing. Therefore, particle-size specifications should be product-specific.
If SDP has verified particle-size data for Croscarmellose Sodium Granules, it can be presented as:
Particle Size: [Actual specification]
or, if available:
D10: [Value]
D50: [Value]
D90: [Value]
Do not use generic D10, D50 or D90 values unless they are supported by the actual product specification.
Similarly, bulk density, tapped density and flowability should be included only when verified.
Quality evaluation of Croscarmellose Sodium includes identity and physicochemical characteristics appropriate to the compendial specification. Published USP information includes identification, pH, loss on drying, degree of substitution, water-soluble material, settling volume and microbial requirements.
Depending on the applicable standard and product specification, additional parameters may include residue on ignition, sodium chloride and sodium glycolate, heavy metals and microbial quality. USP's harmonization documentation identifies several of these attributes as part of the broader compendial control framework for croscarmellose sodium.
Croscarmellose Sodium should be protected from unsuitable environmental conditions and stored according to the applicable product specification. Published USP information states that Croscarmellose Sodium should be preserved in well-closed containers.
For the granulated product, recommended storage conditions should follow the actual SDP product specification and packaging requirements.
Croscarmellose Sodium Granules from Swapnroop can be positioned for customers looking for a pharmaceutical-grade granulated excipient format for formulation and manufacturing requirements. Product-specific specifications, testing parameters and documentation should be confirmed according to the applicable grade and batch documentation.
Croscarmellose Sodium Granules can be considered for:
The final application and use level should be established based on the formulation design, manufacturing process and applicable quality requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 10.0% |
| Residue on Ignition | 14.0–28.0% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0–7.0 |
| Water Content | NMT 10.0% |