Microcrystalline Cellulose Carboxymethyl Cellulose Sodium Co Treated BP EP USP Pharma Grade: Detailed Overview

What is Microcrystalline Cellulose Carboxymethyl Cellulose Sodium Co Treated Material?

Microcrystalline cellulose (MCC) carboxymethyl cellulose sodium (CMC-Na) co treated material belongs to a newer class of excipients supporting the pharmaceutical industry in blending compressibility, fluidity, and viscosity control. This combination draws on the compressive strength of MCC and the swelling or binding properties of CMC-Na. Used widely in tablet manufacturing, these co-processed materials bring efficiency and reliability to the production process, allowing consistent tablet hardness, reduced friability, and suited to formulations that challenge flowability. They fall under global pharmacopoeial standards, such as BP, EP, USP, guaranteeing strict regulatory compliance for critical applications including immediate-release and controlled-release oral drugs.

Product Properties and Specifications

Microcrystalline cellulose paired with carboxymethyl cellulose sodium results in a solid, white to off-white substance, typically encountered as a free-flowing powder or in some cases as dense flakes. This material offers a bulk density range of 0.35 to 0.50 g/cm³, offering manageable packing and flow during mixing. Particle size distribution sits comfortably within 50 to 300 microns, supporting uniform integration with active pharmaceutical ingredients (APIs). Loss on drying generally falls below 7%, so moisture stability in swagging environments stays controlled. Packing density, compressibility, and ability to absorb water without gelatinization make it highly practical for direct compression and wet granulation approaches. Melting point remains undefined due to the structure and thermochemical stability—thermal decomposition occurs over 260°C. For manufacturers, caking and agglomeration are not issues, ensuring storage over long periods without loss in function.

Chemical and Structural Data

Chemically, microcrystalline cellulose presents as a linear, β-1→4-linked D-glucose polysaccharide, crystalline in form, with the formula (C6H10O5)n. Carboxymethyl cellulose sodium modifies cellulose by introducing carboxymethyl groups (-CH2-COONa) along the chain, contributing hydrophilicity and solubilization properties, with the formula C8H15NaO8. Co treated materials physically aggregate or chemically bond—typically seen as intimate blends rather than chemical co-polymers. This pairing does not shift their base molecular weight much, but the composite brings together the high crystallinity of MCC with the amorphous, water-retentive nature of CMC-Na. Together, the structure delivers a porous, non-hygroscopic particle capable of both binding and lubricating in dry or wet tableting processes.

Packaging, Safety, and HS Code

Suppliers deliver these materials in moisture-proof, food-grade polyethylene-lined fiber drums ranging from 25 kg to 50 kg, ensuring both large-scale and small-batch needs are met. For customs and logistics, the HS Code 39123100 covers cellulose ethers—confirming fit for the mixed material. While both components—MCC and CMC-Na—hold an established safety record, material safety data sheets (MSDS) advise basic precautions: avoid dust inhalation, shield eyes and skin in the rare event of hypersensitive reactions, and ensure adequate local exhaust ventilation. Ingestion involves minimal risk at trace residual levels, given their use as permitted excipients and food additives globally. GHS classifications mark them as non-hazardous, non-flammable, and not harmful under standard industrial exposure.

Applications and Raw Material Origins

The backbones of these co processed excipients spring from renewable, plant-based cellulose, often sourced from wood pulp or purified cotton linters for MCC, and tailored by alkali-catalyzed etherification for CMC sodium. This makes the combined excipient both sustainable and scalable, responding to modern demands for green chemistry and consistent chemical traceability. MCC and CMC-Na originate as high-purity powders through rigorous purification, bleaching, and modification processes, each batch certified to comply with stringent BP, EP, and USP monograph specifications. Their use extends past pharmaceuticals to food, cosmetics, and nutraceuticals, reinforcing trust in their raw material integrity.

Physical Forms and Solutions

While microcrystalline cellulose is mostly found as a rigid, crystalline powder, carboxymethyl cellulose sodium arrives as a granular powder or rarely as pearls. In a co treated format, the blend takes the shape of a homogenous, dust-free, slightly granular powder—rarely forming crystals or flakes under usual processing. Their solubility profile is mixed: MCC remains insoluble but suspendable, while CMC-Na dissolves in water, forming clear to slightly opalescent solutions at concentrations below 10%. Co-processed, these components encourage faster disintegration and improved wettability. Diluted with water, the powder partly disperses, increasing viscosity without forming lumps—a vital property for efficient blending during wet granulation or direct compression.

Safe and Effective Use in Drug Formulation

Regulatory oversight supports confidence for formulators using co treated MCC and CMC-Na under BP, EP, USP monographs. Analytical profiles undergo batch-to-batch testing for microbial purity, heavy metals, residual solvents, and pH stability, reducing the odds of contamination. Stability records over typical shelf lives of two to three years further show that co treated materials withstand temperature and humidity swings found in manufacturing or warehouse storage. Pharmaceutical manufacturers benefit from simple integration of this excipient into oral solid dose forms, avoiding irregular tablet breaks, deformations, or delayed disintegration. Attention must be paid to blending times, API compatibility, and avoiding over-compression, as the water-loving character of CMC-Na can otherwise retard drug release if mishandled.

Key Facts and Solutions for Industry Use

Draw on the experience of 21st-century tablet manufacture, this co treated material solves flow and compaction issues once notorious for batch failures. It enables fewer formulation steps, limits the need for lubricants, and prevents the classic sticking or picking observed with MCC alone. Operators relying on automated presses encounter fewer stoppages or pressure spikes, due to the improved lubrication and spreading action of the CMC-Na. To address concerns about over-dusting or inhalation risk, operators should rely on local extraction at the charge hopper and wear standard particulate face masks during extended handling. Raw material tracking from supplier to final batch, through batch certification and unique lot numbers, preserves transparency and trust from drug manufacturer down to pharmacist and patient.

Summary Table: Microcrystalline Cellulose Carboxymethyl Cellulose Sodium Co Treated Material

Material Name: Microcrystalline Cellulose Carboxymethyl Cellulose Sodium Co Treated BP EP USP Pharma Grade
Physical State: Powder, flakes, pearls (rare), non-crystalline
Color: White to off-white
Particle Size: 50–300 microns
Bulk Density: 0.35–0.50 g/cm³
Chemical Structure: (C6H10O5)n + C8H15NaO8 (polymeric blend)
HS Code: 39123100
Solubility: Water (CMC-Na), insoluble (MCC), forms viscous solution
pH (1% sol): 5.0–7.5
Moisture Content: <7%
Shelf-Life: 24–36 months (sealed packaging)
Raw Material Origin: Purified wood pulp/cotton linters (MCC), cellulose plus monochloroacetic acid (CMC-Na)
Safety: Non-toxic, non-hazardous, safe within BP/EP/USP limits
Use: Pharmaceutical excipient for tablets, capsules, sachets