Microcrystalline Cellulose (MCC) CAS 9004-34-6

What is Microcrystalline Cellulose (MCC)?

Microcrystalline cellulose is purified, partially depolymerised cellulose — (C₆H₁₀O₅)n — produced by hydrolysing the amorphous regions out of alpha-cellulose and leaving the crystalline ones behind. What survives is a white, odourless, free-flowing powder with the single most useful property in tablet making: it deforms plastically under pressure and stays deformed.

That plasticity is why MCC is the backbone of direct compression. Most powders either fracture under a punch or spring back after it; MCC flows into the gaps between particles and locks there, generating hardness at low compression forces without any need for water, heat or a granulation step.

It is supplied in grades that differ by particle size and moisture rather than by chemistry. PH 101 at around 50 micrometres, PH 102 at around 100, PH 200 at around 180 for high-speed presses, and PH 112 as a low-moisture grade for water-sensitive actives. The chemistry on the certificate is nearly identical across all of them; the behaviour in your blender is not.

Commercially it is the highest-volume functional excipient in solid dose manufacture, and it is also used as a bulking and anti-caking agent in food and as a spheronisation aid in pellet production. Monographs exist in IP, BP, Ph. Eur. and USP-NF, which makes specification arguments unusually easy to settle.

Why microcrystalline cellulose specifically

• Plastic deformation, not fracture. It compacts by flowing rather than breaking, which gives high tablet hardness at low compression force and long punch life.
• Binder and filler in one. It fills the tablet and holds it together, so a direct compression formula can often be built around it plus the active and a lubricant.
• Dry processing. No water, no drying, no granulation step — which matters enormously for moisture- or heat-sensitive actives.
• Grades that match the press. Particle size is the design variable: finer grades for content uniformity with low-dose actives, coarser grades for flow on high-speed rotary presses.

How MCC is Manufactured

Microcrystalline cellulose is made by stripping the amorphous regions out of purified cellulose and keeping what is left. The source material and the drying method together decide the grade.

• Source selection. Purified alpha-cellulose from wood pulp or cotton linters. The source affects particle morphology and is usually declared, because some customers specify it for regulatory or marketing reasons.
• Acid hydrolysis. Dilute mineral acid hydrolyses the accessible amorphous regions, cutting the chains down to a level-off degree of polymerisation, typically under 350. The crystalline regions survive largely intact.
• Washing and neutralisation. The slurry is washed free of acid and soluble degradation products. Residual water-soluble substances and conductivity on the certificate come from how thoroughly this ran.
• Spray drying. The wet cake is spray dried, and this is the step that creates the grade. Droplet size and drying conditions set the agglomerate size, bulk density and flow — PH 101, 102 and 200 differ here, not in chemistry.
• Milling and classification. Final particle size distribution is set by milling and sieving, then verified against the grade specification.

Typical Commercial Specification

Figures below are representative of PH 102, the most widely used grade. The other grades differ mainly in particle size, bulk density and moisture — tell us the grade or the behaviour you need and we will quote against it.

Physical & Chemical Properties

Behaviour in the formulation

MCC is chemically inert in almost every formulation, so what matters is physical behaviour. Four things define it:

• Compaction. Plastic deformation under pressure creates extensive particle-to-particle contact and strong hydrogen bonding, giving hardness at modest force.
• Disintegration. Water wicks into the compact and disrupts those bonds, so MCC contributes to disintegration as well as to binding — one reason simple formulas work.
• Flow. Coarser grades flow well enough for high-speed presses; fine grades flow poorly and need a glidant or a coarser co-filler.
• Moisture interaction. It holds a few percent water and exchanges it with the environment, which is a benefit for compaction and a problem for moisture-sensitive actives — hence the low-moisture grade.
• Lubricant sensitivity. Over-blending with magnesium stearate coats the MCC surface with a hydrophobic film and softens the tablet. This is the most common cause of a formula that worked in the lab failing at scale.

MCC Grades and the Alternative Fillers

Choosing a filler is a choice about compaction mechanism and flow. Within MCC, the choice is about particle size; between fillers, it is about whether the material deforms, fractures or dissolves.

Stated plainly: MCC deforms and lactose fractures, and a formula usually benefits from having both. MCC supplies the binding and the robustness, lactose supplies solubility, dissolution and cost, and the ratio between them is one of the most-adjusted numbers in solid dose formulation.

Industries We Supply MCC To

The same white powder goes to a tablet press, a capsule filler and a food plant. What changes between them is the grade, the monograph and the supporting statements each sector expects.

Where MCC is Used

MCC does several jobs at once in most formulations, which is why so few solid dose products are made without it. These are the uses our customers buy it for.

In direct compression

The appeal of direct compression is that it removes wetting, granulating, drying and milling from the process — fewer steps, less equipment, less risk to a sensitive active. MCC is what makes it possible, because it binds without water. A typical starting formulation is the active, MCC as binder and filler, a soluble co-filler such as lactose, a disintegrant and a lubricant; the development work is largely about ratios and about not over-blending the lubricant.

In wet granulation

Where direct compression will not work — poor flow, very high drug loading, segregation risk — MCC still earns its place as the filler in the granulation. PH 101 is the usual grade, because the finer particle size gives better wetting and a more uniform granule. Its plasticity also makes the dried granules compress well, which is not true of every filler.

In pellets and spheronisation

Extrusion-spheronisation depends on a wet mass that is plastic enough to extrude and cohesive enough to round off without disintegrating. MCC is the standard spheronisation aid because it holds water in a way that gives exactly that rheology — there is no close substitute, which is why it appears in almost every pellet formulation whether or not it is needed as a filler.

Quality Control & Testing

Every lot is released against a batch-specific Certificate of Analysis written against the monograph you nominate, with the functional parameters that actually drive your process reported alongside the compendial tests.

• Identification and compendial tests — to IP, BP, Ph. Eur. or USP-NF as nominated, including pH, conductivity and water-soluble substances.
• Loss on drying — the figure that matters most for moisture-sensitive actives, and the one that separates PH 112 from the rest.
• Bulk and tapped density — the practical predictor of fill weight and flow behaviour on your press.
• Particle size distribution — by sieve or laser diffraction. The single most useful number for lot-to-lot process control.
• Degree of polymerisation — confirms the hydrolysis ran to the level-off point.
• Residue on ignition and heavy metals — inorganic residue and elemental impurity control.
• Microbial limits — total aerobic count, yeasts and moulds, and absence of specified organisms per the monograph.

Common Process Problems & Likely Causes

When MCC causes trouble on a tablet press, the cause is usually one of a short list of things — and it is more often the blend than the excipient. This table is the shortcut our technical desk works through before anyone opens a complaint file.

Packaging, Storage & Shipping

• Standard packing. 20 or 25 kg net in multi-ply paper bags with polyethylene inner liners, palletised and shrink-wrapped.
• Storage. Cool, dry and well-ventilated, off the floor and away from strong odours. The material is physically stable but takes up moisture from humid air.
• Humidity control. Moisture content drifts toward ambient once a bag is opened. Reseal liners, and in humid plants keep the time between opening and use short.
• Compression of stored bags. Do not over-stack. Compacted bags at the bottom of a tall pallet give a denser, poorer-flowing powder at the point of use.
• Cross-contamination. Odour-absorbent. Store away from strongly scented materials, which it will pick up and carry into the product.
• Shelf life. Typically 36 months in unopened original packing under those conditions. Re-test loss on drying and microbial limits rather than assume.
• Statements. Free of animal-derived material; BSE/TSE, allergen, GMO and, where required, halal and kosher statements supplied with the documentation set.
• Transport classification. Not classified as a dangerous good for transport.

Hazards & Safe Handling

Microcrystalline cellulose is one of the most benign materials in pharmaceutical manufacture, with no significant toxicity by any normal route. The handling considerations are physical rather than toxicological — dust and the explosion risk that any fine organic powder carries.

• Dust explosion risk. Like any fine organic powder, airborne MCC in sufficient concentration is a dust explosion hazard. Earth and bond transfer equipment, control ignition sources and manage dust accumulation on surfaces.
• Nuisance dust. Not toxic, but prolonged exposure to airborne dust irritates the respiratory tract mechanically. Local exhaust ventilation at charging and dispensing points.
• Eye contact. Mechanical irritation only. Safety glasses during dispensing and transfer.
• PPE. Dust mask where dust is generated, safety glasses and normal plant workwear. No special chemical protection is required.
• Housekeeping. Clean up dust accumulation regularly rather than allowing layers to build on beams and ledges, where they become the secondary explosion risk.
• Spill response. Sweep or vacuum avoiding dust clouds. No special decontamination needed.
• Environment. Not hazardous to the aquatic environment. Dispose as ordinary industrial waste in line with local regulations.
• First aid. Flush eyes with water if dust enters them; move to fresh air if dust inhalation causes irritation.

Regulatory & Compliance Notes

Microcrystalline cellulose is a compendial excipient and an approved food additive, with monographs in all the major pharmacopoeias. Because obligations differ by territory and use, the notes below are orientation rather than legal advice — confirm your own position with your regulatory adviser.

• Pharmacopoeial status. Monographs in IP, BP, Ph. Eur. and USP-NF. We supply against the monograph you nominate, with a compliance statement on the COA.
• Food additive status. Permitted as E460(i) in food applications in the major regulatory systems, within the conditions that apply in your market.
• BSE/TSE position. Derived from wood pulp or cotton linters, with no animal-derived material used in manufacture. Statements supplied as standard.
• Allergen and GMO statements. Supplied as part of the standard document set, as required for pharmaceutical and food supply chains.
• Excipient GMP expectations. Supply chains for compendial excipients increasingly expect documented GMP and supplier qualification. Tell us what your quality agreement requires.
• Halal and kosher. Certification available on request for markets and customers that specify it.

We Supply MCC Worldwide

Chelora Chemicals is a supplier and export partner, not a single-plant trader. We ship Microcrystalline Cellulose (MCC) from India to customers across Asia, Europe, the Middle East, Africa, and North and South America, handling the export documentation, pharmacopoeial documentation and freight so the material arrives ready to use.

• Incoterms. EXW, FOB, CIF, CFR and DAP quoted to suit your purchasing terms and freight arrangements.
• Ports. Regular shipments through Nhava Sheva (JNPT) and Mundra, with other Indian ports arranged where it suits the routing.
• Documentation. Commercial invoice, packing list, certificate of origin, COA, SDS and the BSE/TSE, allergen and GMO statements issued as a complete set.
• Flexible volumes. A single bag for laboratory qualification, through LCL consolidations, up to repeat full container loads on a supply contract.
• Supply continuity. Because we are independent of any one producer, a plant turnaround or a shipping disruption at one source does not have to become your stock-out.

Buying MCC from Chelora

We are an independent sourcing and supply partner. For MCC that means settling two things at enquiry: the grade, because PH 101, 102, 112 and 200 are different products that all meet the same monograph, and whether flow or content uniformity is the constraint in your process — because that is what decides the grade.

• Documentation on every lot. Batch-specific COA written against the nominated monograph, with bulk density and particle size reported alongside, plus SDS, TDS and the supporting statements.
• Samples before commitment. Trial quantities for formulation qualification ahead of a commercial order.
• Quantities. From a single 25 kg bag through to full container loads on contract supply.
• Grade selection support. Practical advice on which PH grade suits your press speed, drug loading and moisture sensitivity.
• Export experience. Packing, labelling and export documentation handled for sea and air freight.
• Related excipients. Lactose monohydrate, povidone, HPMC and magnesium stearate from one supplier, which keeps a direct compression formula on a single order.

How ordering works

• Send the enquiry. Product, grade or pharmacopoeia standard, quantity, destination port and the Incoterm you buy on. If you have a spec sheet, attach it — it saves a round trip.
• We quote. Price, lead time, packing and a sample COA, normally within one working day.
• Sample and qualify. For first orders or critical applications, we send a trial quantity so your lab can sign off before you commit.
• Confirm the order. Proforma invoice issued; payment terms agreed against the volume and the relationship.
• Production and QC. Material allocated and released against a batch-specific COA, with a pre-shipment sample where the application calls for it.
• Ship and document. Packed, labelled and loaded with the full export document set, and tracked through to arrival.

Related Pharmaceutical Excipients & Intermediates

Buyers of MCC usually source several of these alongside it — most direct compression formulations use four or five of them together. Consolidating them on one order cuts freight cost and gives you a single point of contact for documentation.