Croscarmellose Sodium DC Granules are pharmaceutical-grade granulated excipient material developed for formulation applications where a direct-compression-oriented physical format and consistent material handling are required. Croscarmellose Sodium is a cross-linked, partly O-(carboxymethylated) cellulose sodium salt and is recognized in the USP–NF as a pharmaceutical excipient.
Croscarmellose Sodium is widely used as a functional excipient in oral solid formulation development because of its disintegration functionality. The DC Granules format provides a granulated presentation intended to support formulation processing, blending and handling where the physical characteristics of the granulated material are appropriate for the intended manufacturing process.
Croscarmellose Sodium is a chemically cross-linked derivative of cellulose containing carboxymethyl groups. The USP defines it as the sodium salt of a cross-linked, partly O-(carboxymethylated) cellulose.
The material is commonly associated with pharmaceutical excipient applications, particularly in oral solid dosage-form development. Its functional properties make it useful when formulation developers require a disintegrant excipient with controlled physicochemical characteristics.
CAS Number: 74811-65-7
Croscarmellose Sodium is polymeric in nature. Therefore, a conventional single molecular-weight value should not be presented as a fixed product specification in the same manner as a low-molecular-weight chemical substance.
Croscarmellose Sodium DC Granules are intended for applications where the granulated physical form can provide suitable handling and processing characteristics for direct-compression-oriented formulation systems.
Direct-compression formulation development depends on appropriate powder or granulated-material characteristics, including flow, blending behavior, compressibility and consistency. For this reason, the actual physical properties of a DC granule product should be controlled according to the manufacturer's established specification.
Relevant product characteristics may include:
These values should be reported only when verified for the specific Croscarmellose Sodium DC Granules grade.
Croscarmellose Sodium is primarily used as a disintegrant excipient. Its cross-linked cellulose structure supports its functional role in oral solid formulations.
For formulation developers, selection of an appropriate grade depends on the formulation composition, manufacturing process, target performance and compatibility with other excipients. The concentration and processing conditions should therefore be established during formulation development rather than assumed as a universal value.
The granulated form can provide a different physical presentation from conventional fine excipient powder. Particle-size distribution and granule morphology may influence material flow, blending, segregation and downstream processing.
For Croscarmellose Sodium DC Granules, the product specification may therefore include granule-specific parameters such as particle-size range, bulk density, tapped density and flow characteristics.
Where SDP has verified data, these can be presented as:
Particle Size: [Verified specification]
Bulk Density: [Verified specification]
Tapped Density: [Verified specification]
Flowability: [Verified specification]
If these parameters are not part of the approved specification, they should not be presented as fixed numerical specifications.
Croscarmellose Sodium has established USP–NF quality requirements. The current USP monograph identifies identification, pH, residue on ignition, degree of substitution, loss on drying, water-soluble substances and settling volume, among other requirements.
The harmonized USP material specifies a degree of substitution of 0.60–0.85 on the dried basis and a settling volume of 10.0–30.0 mL under the specified test conditions.
The established USP material also specifies loss on drying not more than 10.0% and water-soluble material not more than 10.0% under the applicable procedures.
These parameters help characterize the chemical and physical quality of Croscarmellose Sodium. For a specific DC Granules product, the final release specification should follow the applicable grade and approved product specification.
Croscarmellose Sodium DC Granules may be considered for pharmaceutical formulation applications including:
The actual application and use level should be determined according to the formulation design, manufacturing process and applicable quality requirements.
A controlled granulated format can be useful where formulation developers require specific physical handling characteristics. Depending on the manufacturing process, granulation can influence particle-size distribution, flow, bulk density and material handling.
For this reason, Croscarmellose Sodium DC Granules should be evaluated based on both the chemical quality of Croscarmellose Sodium and the physical characteristics of the granulated product.
Quality control of Croscarmellose Sodium includes appropriate identification and physicochemical testing. USP–NF information identifies pH, residue on ignition, degree of substitution, loss on drying, water-soluble substances and settling volume among the relevant attributes.
Depending on the applicable specification, additional controls can include sodium chloride and sodium glycolate, microbial quality and other product-specific requirements. USP's harmonization documentation identifies these attributes within the Croscarmellose Sodium quality framework.
For DC Granules, additional physical testing may be applicable when included in the approved product specification.
Croscarmellose Sodium should be stored under conditions that protect the material from unsuitable environmental exposure. The USP material specifies preservation in well-closed containers.
The storage conditions for Croscarmellose Sodium DC Granules should follow the product's approved packaging and storage requirements.
Croscarmellose Sodium DC Granules can be considered for:
| 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% |
| pH (1% Solution) | 5.0–7.0 |
| Water Content | NMT 10.0% |