Microcrystalline Cellulose
MCC earns its place in almost every tablet formulation for one mechanical reason: it deforms plastically instead of shattering. Press it and the particles flatten and lock together, giving hard tablets at modest compression force — which is why direct compression became practical at all.
Chelora Chemicals supplies microcrystalline cellulose to pharmaceutical, nutraceutical and food manufacturers worldwide, in compendial grades, with a batch COA, GHS safety data sheet and the regulatory statements your QA file needs.
Product identity
- CAS Number
- 9004-34-6
- Compendial name
- Cellulose, microcrystalline
- EC / EINECS
- 232-674-9
- Food additive number
- E460(i)
- Pharmacopoeias
- USP-NF · Ph. Eur. · JP · IP · BP
- Common grades
- PH-101 · PH-102 · PH-200 · PH-112
- Transport status
- Non-hazardous
- HS Code
- 3912 90*
* Confirm the exact HS heading with your customs broker — cellulose derivatives can sit under a different subheading depending on the destination tariff schedule and the declared end use.
What Microcrystalline Cellulose is used for
Microcrystalline cellulose is a white, odourless, tasteless free-flowing powder made by controlled acid hydrolysis of purified plant cellulose. The hydrolysis strips out the amorphous regions of the cellulose chain and leaves the crystalline fragments behind — which is where the name, and the compression behaviour, both come from.
Its dominant use is as a binder and diluent in solid dosage forms. In direct compression it supplies both bulk and binding in a single ingredient; in wet granulation it acts as a filler and granulation aid; in capsules it fills and flows. It also appears as a food and nutraceutical ingredient under E460(i), where it works as a bulking and anti-caking agent.
Where it sits among tablet fillers
- Microcrystalline cellulose (this product) plastic deformation; the strongest compacts per unit force, and the usual backbone of a direct-compression blend.
- Lactose monohydrate brittle fracture; cheaper, excellent flow, but incompatible with primary amines. See that page.
- Mannitol non-hygroscopic and pleasant in the mouth; the choice for chewables and moisture-sensitive actives. See that page.
- Dicalcium phosphate high density and brittle; used where tablet weight and hardness matter more than compressibility.
Most real formulations combine two of these rather than relying on one — see the full excipient range.
Appearance and handling character
The material ships as a low-bulk-density white powder, practically insoluble in water, dilute acids and most organic solvents, but it swells and disperses in water to a stable suspension. It is not classified as a hazardous substance; the practical handling considerations are dust generation, static build-up during pneumatic transfer, and moisture pick-up from the warehouse atmosphere.
| Parameter | Typical value |
|---|---|
| Appearance | White, odourless, free-flowing powder |
| Identification | Conforms (IR / colour reaction) |
| Loss on drying | 5.0% max |
| pH (aqueous suspension) | 5.0 – 7.5 |
| Water-soluble substances | 0.25% max |
| Ether-soluble substances | 0.05% max |
| Residue on ignition | 0.1% max |
| Degree of polymerisation | 350 max |
| Microbial limits | TAMC ≤ 1000 cfu/g · TYMC ≤ 100 cfu/g |
Important: the figures above are indicative of compendial-grade material and are offered for planning only. The batch certificate of analysis is the governing document. Tell us which pharmacopoeias your filing cites and we will quote against those monographs.
| Grade | Nominal size / use |
|---|---|
| PH-101 | ≈ 50 µm · wet granulation |
| PH-102 | ≈ 100 µm · direct compression |
| PH-200 | ≈ 180 µm · high-speed press flow |
| PH-105 | ≈ 20 µm · fine, content-uniformity work |
| PH-112 | Low moisture (≤ 1.5%) · moisture-sensitive APIs |
| PH-301 / 302 | High density · small, heavy tablets |
Grade designations follow the convention established by the major producers. Equivalent grades exist under other brand names — send us the grade you currently use and we will cross-reference it.
Where our customers put this excipient to work
MCC does several jobs at once in a formulation, which is exactly why it is so hard to design out of one.
Direct compression tableting
Supplies bulk, binding and compressibility in one ingredient, removing the granulation step entirely for suitable actives.
- PH-102 and PH-200 grades
- Flow and compressibility data available
- Blend trials supported
Wet granulation
Acts as filler and granulation aid, improving granule strength and keeping the dried granule compressible.
- PH-101 is the standard grade
- Pairs with PVP K30 as binder
- Technical desk review of your blend
Hard capsule filling
Free-flowing grades fill capsules consistently at speed and give reproducible fill weight without a separate glidant-heavy blend.
- PH-102 and PH-200 grades
- Bulk density reported per batch
- Pairs with magnesium stearate
Disintegration support
Water wicks rapidly into an MCC matrix, helping tablets break up even before the superdisintegrant takes over.
- Pairs with croscarmellose sodium
- Dissolution support on request
- Formulation guidance available
Nutraceutical & food use
Bulking and anti-caking agent under E460(i), widely used in supplement tablets, powdered blends and shredded cheese.
- Food-grade specification available
- Halal, kosher and vegan statements
- Non-GMO declaration on request
Contract & scheduled supply
Formulators consume MCC continuously. We hold inventory and release it against your production calendar.
- Annual contracts with scheduled call-off
- Price held across the contract period
- Second source held in reserve
How we supply Microcrystalline Cellulose
Chelora Chemicals is a supplier and sourcing partner, not a manufacturer. On an excipient, owning no plant means we are never pushing you a grade because it is the one we happen to make — we route your order to the producer whose particle size distribution and compendial coverage actually match your formulation.
We place your order with whichever qualified producer best matches your grade, your compendial requirement, your price point and your delivery window.
We keep a second qualified source on this line. Excipient changes are a regulatory event, so we would rather you qualify the alternate in advance than scramble when a plant goes down.
- Grade cross-referenced before we quote. Send the brand and grade you currently buy and we will identify the equivalent rather than guessing from a particle-size number.
- Compendial coverage confirmed up front. USP-NF, Ph. Eur., JP or IP — we establish which monographs your filing cites before the quote, not after.
- Full regulatory statement pack. BSE/TSE, GMO, allergen, residual solvent, elemental impurity and nitrosamine risk statements, supplied with the consignment.
- Batch COA shared before dispatch. You approve the batch against your own spec while the material is still in our warehouse.
- Pre-shipment samples for formulation trials. Excipient changes need data, so your laboratory runs compression trials before the full quantity moves.
- Change notification taken seriously. If a source plant changes anything that touches your filing, you hear about it from us first.
Packed the way your plant receives it
MCC is bulky and light, so pack format drives your freight cost more than on almost any other excipient. Tell us how the material will be charged at your end and we will quote the format that suits your operation.
Multiwall paper bags
Kraft bags with an inner PE liner on shrink-wrapped pallets — the standard pharmaceutical format and the lowest cost per kilo.
Fibre drums
Lined fibre drums where your store handles drums rather than bags, or where the bag format risks damage in transit.
Jumbo bags (FIBC)
Lined, discharge-spout FIBCs for high-volume users with bulk-bag handling, cutting manual bag tipping out of the process.
Trial / sample quantities
Small packs dispatched so your formulation team can run compression and blend trials before committing to a grade.
Incoterms to suit you
Quoted on the Incoterm your purchasing team works to, with export documentation filed before the booking is made.
Campaign despatch
We hold contracted tonnage and release it against your production calendar instead of filling your warehouse at once.
Not a hazardous substance — but still a fine powder
MCC is not classified as hazardous under GHS and has a long history of safe use in food and medicine. What it does need is sensible powder handling: dust control, static management on pneumatic transfer, and protection from moisture. The summary below is orientation only — the safety data sheet supplied with your consignment is the authoritative document.
Hazard position
GHSNot classified as a hazardous substance or mixture.DUSTNuisance dust; may cause mechanical irritation to eyes and the respiratory tract.ATEXOrganic powder — combustible dust precautions apply in enclosed handling.STATICCan accumulate electrostatic charge during pneumatic transfer; bond and earth.
MCC's unclassified status is not a reason to skip a dust assessment. Any fine organic powder handled in an enclosed space has a combustible-dust dimension, and your process-safety team should treat it as such. Always read the SDS issued with your specific batch.
Practical handling notes
- Bond and earth transfer equipment. MCC charges readily on pneumatic conveying, and static is the practical ignition concern rather than the powder itself.
- Extract at tipping and charging points. Nuisance dust at a bag tip is the commonest comfort complaint on this product.
- Re-seal partial bags immediately. The powder equilibrates with ambient humidity, and moisture pick-up shows up directly in your LOD and in tablet hardness.
- Keep it away from strong odours. MCC adsorbs volatile compounds readily; do not store it next to solvents or strongly scented material.
- Clean up by vacuum. Dry sweeping a light powder re-suspends it across the room.
Storage
- Cool, dry, well-ventilated store. Ordinary warehouse conditions are sufficient; no temperature control is needed.
- Keep containers tightly closed. The liner is what keeps moisture out — a torn liner on a pallet is a batch risk, not a cosmetic issue.
- Keep off the floor and away from walls. Standard GMP warehousing practice; condensation against an external wall will reach the bag before it reaches the room.
- Segregate from strongly scented materials. Adsorbed odour carries into the finished dosage form.
- Shelf life typically 36 months. In sealed original packing. Re-test against your specification after extended storage.
Handling & PPE
- Standard GMP powder handling. Local exhaust at tipping points, gloves, safety glasses and a dust mask where airborne powder is generated.
- Static control on transfer. Earthed equipment and conductive liners where the material is conveyed pneumatically.
- Dedicated scoops and containers. Cross-contamination control matters more here than personal protection.
- Blend time matters. Over-blending MCC with a hydrophobic lubricant costs you tablet hardness — a formulation point rather than a safety one, but the commonest real-world problem.
- Dispose of as ordinary non-hazardous waste. Subject to your local waste classification.
Transport
Microcrystalline cellulose is not a regulated dangerous good and ships as general cargo by road, sea and air. We issue the commercial and compendial documentation with every consignment — ask us for the full document pack when you plan the shipment.
What travels with every consignment
On an excipient the documentation is half the product. A grade that performs perfectly and arrives without the right statements is still a batch your QA cannot release.
Certificate of Analysis
Batch-specific results against the compendial monographs you cite, including LOD, pH, soluble substances, residue on ignition and microbial limits.
GHS Safety Data Sheet
Full 16-section SDS in GHS format, issued in the language your destination requires, confirming the unclassified status in writing.
BSE / TSE & GMO statements
Confirmation of plant origin with no animal-derived material at any stage, plus non-GMO declaration where your market requires it.
Elemental impurities & residual solvents
ICH Q3D elemental impurity data and residual solvent statements on request, with a nitrosamine risk assessment statement where your filing needs one.
Halal, kosher & allergen
Certification and allergen statements supplied with the consignment, covering the declarations most commonly requested by QA.
Retained & pre-shipment samples
Pre-shipment samples carry the same COA as the commercial lot, so what your laboratory qualifies is exactly what arrives.
Crystalline fragments that flatten under pressure
MCC's whole value proposition is mechanical. Understanding where it comes from explains why grade selection matters so much. The steps below are the general industrial pattern, not a process disclosure.
Start from purified cellulose pulp
Wood or cotton-derived alpha-cellulose pulp is purified to remove lignin, hemicellulose and extractives.
Hydrolyse the amorphous regions
Controlled dilute-acid hydrolysis attacks the disordered chain segments, leaving crystalline microfibril fragments.
Wash, neutralise and dry
The slurry is washed free of acid, neutralised and spray-dried — and it is the drying step that sets particle size and density.
Classify into grades
Milling and classification produce the PH-101, PH-102 and PH-200 particle-size grades that differ in flow and compressibility.
Why grade and moisture decide your tablet
Two bags of MCC can both meet the monograph and still behave very differently on your press:
- Particle size trades flow against compressibility. Coarser grades flow better but compress slightly less strongly — which is why PH-200 exists for high-speed presses and PH-101 for granulation.
- Moisture is a plasticiser, not just a number. MCC at the low end of its LOD range compacts noticeably harder than material at the top end; a low-moisture grade is a different formulation, not a drier version of the same one.
- Lubricant sensitivity is real. MCC is the excipient most affected by over-blending with magnesium stearate — hardness falls measurably with blend time.
- Bulk density sets your fill weight. A density shift between sources changes die fill before it changes anything else, so it belongs on your incoming specification.
That is why we cross-reference the exact grade you use rather than quoting "MCC", and why the batch COA is shared for approval before dispatch rather than sent with the invoice.
| Material | Compression behaviour |
|---|---|
| Microcrystalline cellulose CAS 9004-34-6 — this product | Plastic deformation |
| Lactose monohydrate CAS 64044-51-5 | Brittle fracture |
| Mannitol CAS 69-65-8 | Brittle · non-hygroscopic |
| Povidone K30 CAS 9003-39-8 | Solution binder, not a filler |
We supply across the excipient range — see the full excipient range. Send your formulation and we will confirm the grades before quoting.
What actually moves the price of this product
Knowing what drives the quote helps you time a purchase and read whether an offer is realistic.
Dissolving pulp cost
MCC starts from purified cellulose pulp, so the dissolving-pulp market and its paper-sector competition feed straight through.
- Pulp tracks forestry and energy costs
- Cotton linter grades price separately
- We flag feedstock-driven moves in the quote
Energy and drying cost
Spray drying is the energy-intensive step, so gas and power prices at the source plant show up in the quote within a quarter.
- Energy is the single biggest conversion cost
- Low-moisture grades cost more to make
- Contracted call-off smooths the exposure
Freight on a low-density powder
MCC cubes out a container long before it weighs out, so freight per kilo is unusually high and pack format matters.
- Always compare on landed cost
- Container utilisation drives the number
- We quote FOB, CIF, CFR or DDP as you prefer
Grade and compendial coverage
A single-pharmacopoeia technical grade and a multi-compendial pharma grade with full statements are different products at different prices.
- Specify only the monographs you actually cite
- We will say when a simpler grade will do
- Over-specification is the commonest cost leak
Source qualification lead time
Changing MCC source is a regulatory event, so the real cost of a supply gap is the requalification, not the spot price.
- We hold a second qualified source on this line
- Qualify the alternate before you need it
- Ask us about dual-source contracts
Nutraceutical demand
Supplement manufacturing competes for the same grades as pharma and can tighten availability without warning.
- Ask us what the nutra market is doing
- Long-term contracts lock in supply
- We hold inventory on fast-moving grades
| If your process is… | Specify |
|---|---|
| Direct compression | PH-102, or PH-200 for high-speed press flow |
| Wet granulation | PH-101 |
| Moisture-sensitive API | PH-112 low-moisture grade |
| Low-dose content uniformity | PH-105 fine grade |
| Small, dense tablets | PH-301 / PH-302 high-density grade |
| Capsule filling | PH-102 or PH-200 |
Not sure which row you are in? Describe your press, your API and your current blend and our technical desk will recommend the grade — including telling you when the grade you already buy is the right one.
Support that goes beyond shipping the pallet
What our technical desk will do
- Cross-reference your current grade first. Brand designations differ between producers and a wrong equivalence costs you a failed batch, so we settle it before quoting.
- Confirm which pharmacopoeias you cite. Multi-compendial material costs more than single-monograph material, and there is no point paying for tests your filing does not reference.
- Flag the lubricant sensitivity. If you are moving to MCC from a brittle filler, your blend time and lubricant level both need revisiting.
- Get you the statement pack early. BSE/TSE, GMO, allergen and elemental impurity statements arrive with the sample, not after the order.
Regulatory & compliance notes
- Excipient change control is yours to manage. Tell us which products this feeds and we will treat source changes as notifiable rather than routine.
- Compendial monographs differ in detail. USP-NF, Ph. Eur., JP and IP are close but not identical; we confirm coverage rather than assuming harmonisation.
- GMP expectations vary by market. IPEC-style excipient GMP documentation is available where your market expects it.
- Food and pharma grades are not interchangeable. If the same material serves both, the specification should be written to the stricter of the two.
None of the above is legal advice — your own regulatory affairs team owns the final compliance position for your import and your filing. What we commit to is accurate product identity data, correctly matched grades and complete documentation to work from.
From enquiry to delivered pallet
Send the specification
Grade (PH-101, PH-102, PH-200 or equivalent), the pharmacopoeias you cite, quantity, pack preference and destination port.
Receive a firm quote
Pricing, lead time, packing and Incoterm confirmed in writing within 24 hours — our sourcing desk is staffed around the clock.
Qualify and approve
Sample dispatched with the full statement pack for your formulation trials. Batch COA shared for approval before release.
Ship and track
Freight booked, export documents issued, and the consignment tracked through transit and clearance to your plant.
What buyers ask us about Microcrystalline Cellulose
What is microcrystalline cellulose used for?
What is the difference between PH-101 and PH-102?
Which grade should I use for direct compression?
Is MCC compliant with pharmacopoeial monographs?
What microbial and elemental impurity data do you provide?
Is it suitable for vegetarian, vegan, halal and kosher products?
What is the minimum order quantity?
How should we store it?
Do you manufacture this yourself?
Request pricing on Microcrystalline Cellulose
Send your grade, the pharmacopoeias you cite, quantity, pack format and destination port. Our sourcing desk is available 24 hours a day, 7 days a week, and comes back with pricing, lead time and packing options — whether that is a single trial pack or a contracted programme for the year.