Croscarmellose Sodium EC Granules are pharmaceutical-grade granulated material designed for formulation applications where croscarmellose sodium is incorporated into an enteric-coated granule system. Croscarmellose Sodium is a cross-linked cellulose-based pharmaceutical excipient widely used for its disintegration functionality in oral solid formulations. Its CAS Number is 74811-65-7.
In an EC (enteric-coated) granule system, the coating is responsible for controlling exposure of the granule to the gastrointestinal environment, while Croscarmellose Sodium can serve its functional excipient role within the formulation. The exact coating composition, coating weight gain, dissolution profile and release characteristics must therefore be defined according to the actual SDP product specification.
Croscarmellose Sodium is the sodium salt of a cross-linked, partly O-(carboxymethylated) cellulose. It is recognized in the USP–NF as a pharmaceutical excipient.
It is also referred to as cross-linked carboxymethylcellulose sodium, cross-linked sodium CMC, and modified cellulose gum. PubChem identifies CAS Number 74811-65-7.
Because Croscarmellose Sodium is polymeric, it does not have a single fixed molecular weight in the same way as a conventional low-molecular-weight chemical substance. Therefore, a fixed molecular weight should not be entered into the SDP product data unless it is specifically defined by the applicable product specification.
Croscarmellose Sodium is primarily used as a functional disintegrant excipient. In a granulated formulation, its physical presentation can be important for blending, processing and uniform distribution of the excipient.
For an EC granule product, the final performance depends on the complete formulation rather than on Croscarmellose Sodium alone. Relevant characteristics can include:
Only verified product-specific values should be published for these characteristics.
Enteric coating is used to provide resistance to the specified acidic environment and to allow release under the conditions defined by the formulation and applicable testing method.
For Croscarmellose Sodium EC Granules, the enteric performance should be demonstrated through the actual product's validated dissolution/release testing. It would not be appropriate to assign a generic dissolution value to every EC granule product.
Where SDP has a validated specification, the page can include:
Coating Type: Enteric coating
Coating Weight Gain: [Verified value]
Acid-Stage Performance: [Verified specification]
Buffer-Stage Dissolution: [Verified specification]
These values should come directly from the approved product specification or batch documentation.
Croscarmellose Sodium contributes functional excipient properties to oral solid formulations. Its cross-linked structure is associated with its use as a disintegrant.
The USP material describes specific quality characteristics for Croscarmellose Sodium, including identification, pH, loss on drying, degree of substitution, water-soluble material and settling volume.
The established Croscarmellose Sodium compendial framework includes a degree of substitution of 0.60–0.85 on the dried basis. Loss on drying is specified at not more than 10.0% in the cited USP harmonization material, and the settling volume is specified at 10.0–30.0 mL under the stated test conditions.
For the EC granulated product, these excipient characteristics should be considered together with the additional requirements applicable to the enteric-coated granule system.
Particle-size distribution is an important physical characteristic for granulated pharmaceutical materials because it can influence flow, blending, segregation, coating uniformity and downstream processing.
For Croscarmellose Sodium EC Granules, SDP should publish a particle-size range only when it has been established in the product specification.
For example:
Particle Size: [Actual SDP specification]
If validated analytical data are available:
D10: [Value]
D50: [Value]
D90: [Value]
Do not use generic D10/D50/D90 values merely to populate the webpage.
Moisture can influence the physical characteristics and processing behavior of granulated excipients. Croscarmellose Sodium has a compendial loss-on-drying requirement, while the finished EC granule may have an additional product-specific moisture specification.
Other physical properties that may be controlled for the finished granules include:
The numerical acceptance criteria should be taken from the actual SDP specification.
Quality control for the Croscarmellose Sodium component can include identity, pH, loss on drying, degree of substitution, water-soluble material and settling volume.
For the finished EC Granules, additional controls may be required depending on the product design, including:
The exact tests should correspond to the actual formulation and approved specification.
Croscarmellose Sodium EC Granules may be considered for formulation and manufacturing applications involving:
The final application depends on the formulation design and validated manufacturing process.
Croscarmellose Sodium should be stored according to the applicable product specification and packaging requirements. The USP harmonization material specifies preservation in well-closed containers.
The finished EC granules should be protected from conditions that could adversely affect the coating, moisture level or physical integrity of the granules.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |