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Carboxymethylcellulose Calcium BP EP USP Pharma Grade: Description and Key Details

What is Carboxymethylcellulose Calcium Pharma Grade?

Carboxymethylcellulose Calcium, recognized in the pharmaceutical world for its consistent performance, works as a stabilizer, thickener, and binder in many products. This compound shows up in oral dosage forms, especially where controlled release is essential. For those used to handling raw materials in large-scale manufacturing, the familiarity with Carboxymethylcellulose Calcium stretches beyond its name—it covers every detail from texture and consistency to the way it blends with other powders. Its importance cannot be overstated for anyone focused on pharmaceutical safety, compliance, and efficiency.

Physical and Chemical Properties

As a solid, Carboxymethylcellulose Calcium typically appears as white to off-white flakes, powders, or even small pearls, each form chosen based on the needs of a specific formulation. The texture might feel gritty or slick, depending on grade and granule size. In solution, it takes on a colloidal nature, blending into liquids without clumping when properly mixed. The density often sits around 0.5–0.7 g/cm³ for loose powder. Molecularly, this is a calcium salt of carboxymethylcellulose, loosely forming a network of cellulose chains that’s been carboxymethylated and crosslinked with calcium ions. The empirical formula reads as (C6H7O2(OH)2COO)₂Ca, showcasing both the organic backbone and the bridging calcium. Its structure grants it a unique water-dispersible ability, which keeps formulations stable over time under typical pharmaceutical conditions.

Specifications and Testing Standards

Pharma grade Carboxymethylcellulose Calcium aligns with stringent standards under leading pharmacopeias such as BP, EP, and USP. These compendia demand tight control over heavy metals, microbial limits, pH range (often 6.0–8.5 for a 1% solution), and degree of substitution (usually 0.6–0.95 on the anhydroglucose unit). Moisture content rarely exceeds 10%, helping prevent unwanted chemical changes during storage. Granule or particle size distribution, viscosity (measured in mPa·s for aqueous solutions at fixed concentrations), and calcium content receive specific attention in each quality control batch. These tests keep both the product’s function and its safety profile reliable for daily use within the pharma sector.

HS Code and Regulatory Profile

Customs authorities classify Carboxymethylcellulose Calcium under HS Code 39123100, which covers cellulose and its chemical derivatives. Anyone working in supply chain management knows that getting the code right influences taxes, import clearances, and regulatory documentation. Compliance officers cross-check this code when preparing batch shipments, as it supports traceability and upholds legal standards for pharmaceutical raw material movement across borders.

Forms: Flakes, Powder, Pearls, and Solutions

Solid forms such as flakes, powder, and pearls offer flexibility for manufacturers. Each form plays a different role in the process—the powder dissolves rapidly for tablet coating, the flakes suit granule-based blends, and pearls may assist in controlled layering. In liquid or crystal clear solutions, Carboxymethylcellulose Calcium creates smooth dispersions, especially helpful in oral suspensions and gels. Some pharma labs keep multiple forms on hand, preferring one over another depending on how the final product feels, dissolves, or delivers active ingredients.

Molecular Structure and Physicochemical Features

Understanding the molecular structure gives a deeper insight into its reliable performance. The cellulose backbone hosts carboxymethyl groups, where some hydroxyl sites get replaced to improve water dispersibility and interaction with calcium ions. The crosslinked calcium carboxymethylcellulose does not simply sit in a solution—its network forms a gel-like structure that resists collapse and provides even diffusion. Specific attention goes towards its molecular weight, which ranges widely based on the degree of polymerization, often controlled during synthesis to balance viscosity with solubility.

Handling, Storage, and Safety Considerations

Material safety data sheets highlight that Carboxymethylcellulose Calcium generally remains non-toxic and poses low risk to workers if used according to standard procedures—dust inhalation should still be minimized in powder processing areas. Gloves and masks typically suffice for handling. Storage requires dry, cool conditions to ward off moisture pickup, which could clump the powder or degrade functional quality over time. Equipment for weighing and dispensing should be kept clean to avoid cross-contamination with other excipients, especially for manufacturers with strict batch traceability rules. Even though not considered hazardous or acutely harmful, all pharmaceutical handling protocols demand regular safety checks and documentation from raw material receipt through to finished product delivery.

Applications and Industry Relevance

Over the years, Carboxymethylcellulose Calcium has gained favor across multiple areas, especially in developing oral solid dosage forms and various topical applications. Extended-release tablets rely on its gel-forming properties to manage drug release, while oral suspensions depend on its ability to hold particles in a uniform state without settling. When used as a raw material, product developers evaluate its compatibility with a range of active pharmaceutical ingredients, pH sensitivity, and stability over extended periods. During earlier days working in development labs, the need for precise control over viscosity in prototype suspensions highlighted why sourcing a pharma-grade Carboxymethylcellulose Calcium made a real difference—less downtime, fewer formulation headaches, and better final product quality. Attention to this level of detail goes far to build patient trust and regulatory confidence, proving that understanding and selecting the right excipients keeps the industry moving in the right direction.