Croscarmellose Sodium
Croscarmellose is the excipient that makes a hard tablet fall apart on purpose. Crosslinking makes the carboxymethylcellulose fibres insoluble, so instead of dissolving into a gel they wick water inward and swell against the compact until it breaks.
Chelora Chemicals supplies croscarmellose sodium to pharmaceutical and nutraceutical 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
- 74811-65-7
- Compendial name
- Croscarmellose Sodium
- Chemical description
- Crosslinked sodium carboxymethylcellulose
- Degree of substitution
- 0.60 – 0.85
- Food additive number
- E468
- Pharmacopoeias
- USP-NF · Ph. Eur. · JP · IP · BP
- Transport status
- Non-hazardous
- HS Code
- 3912 31*
* Confirm the exact HS heading with your customs broker — cellulose ether salts can sit under a different subheading depending on the destination tariff schedule and the declared end use.
What Croscarmellose Sodium is used for
Croscarmellose sodium is a white to off-white, free-flowing fibrous powder: sodium carboxymethylcellulose that has been internally crosslinked so that it swells in water without dissolving. That one modification changes the material completely — ordinary Na-CMC makes a viscous solution and would slow your tablet down, while the crosslinked version breaks it open.
Its only significant use is as a superdisintegrant in solid dosage forms, normally at 2–5%. It is effective in direct compression, wet granulation and roller compaction, and is equally at home in hard capsules where rapid shell-content dispersion matters.
Where it sits among disintegrants
- Croscarmellose sodium (this product) wicking plus fibre swelling; the most broadly robust choice across different actives.
- Sodium starch glycolate high-volume swelling; very effective but can form a gel layer at higher levels.
- Crospovidone almost pure wicking with minimal swelling; preferred where swelling would hurt the dosage form.
- Starch and MCC conventional disintegrants, needing far higher levels for the same effect. See the MCC page.
Many formulations use croscarmellose alone; some pair it with a second mechanism — see the full excipient range.
Appearance and handling character
The material is hygroscopic and insoluble in water, forming a swollen dispersion rather than a solution. It is not classified as a hazardous substance. The practical handling considerations are keeping absorbed moisture out — because moisture already taken up is swelling capacity you have spent — and getting the material distributed evenly through a blend, since a superdisintegrant that is unevenly mixed produces tablets that disintegrate unevenly.
| Parameter | Typical value |
|---|---|
| Appearance | White to off-white free-flowing powder |
| Identification | Conforms |
| Degree of substitution | 0.60 – 0.85 |
| Loss on drying | 10.0% max |
| pH (1% dispersion) | 5.0 – 7.0 |
| Settling volume | 10 – 30 mL |
| Water-soluble material | 10.0% max |
| Sodium chloride + sodium glycolate | 0.5% 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. Degree of substitution and settling volume are the figures that most affect disintegration performance — tell us your target and we will quote against it.
| Material | Mechanism / typical level |
|---|---|
| Croscarmellose sodium | Wicking + swelling · 2 – 5% |
| Sodium starch glycolate | Swelling · 2 – 8% |
| Crospovidone | Wicking · 2 – 5% |
| Low-substituted HPC | Swelling + binding · 5 – 10% |
| Maize starch | Conventional · 5 – 15% |
Use levels are indicative starting points for formulation work, not specifications. The right level depends on your API, your compression force and your dissolution target.
Where our customers put this excipient to work
One job, done well, across almost every solid dosage form — which is why it appears in so many formulations at a low percentage.
Direct compression tablets
Added at the final blend stage, typically at 2%, where it survives compression intact and goes to work the moment the tablet meets water.
- Pairs with MCC PH-102
- Blend uniformity critical
- Formulation guidance available
Wet granulation
Usually split between the granulating phase and the final blend, so the granule breaks down as well as the tablet.
- Split intra- / extragranular addition
- Pairs with PVP K30 as binder
- Technical desk review of your blend
Hard capsule formulations
Disperses the capsule contents quickly once the shell opens, which is often the rate-limiting step in capsule dissolution.
- Capsule fill blends
- Low use level keeps fill weight down
- Dissolution support on request
Orally disintegrating tablets
Used where the tablet has to break down in the mouth in seconds, typically alongside a second disintegrant mechanism.
- ODT formulation
- Pairs with mannitol for mouthfeel
- Fine-particle grades available
Nutraceutical tablets
Supplement tablets are often large and heavily compressed, which is exactly where a superdisintegrant earns its place.
- Food-grade E468 specification available
- Halal, kosher and vegan statements
- Non-GMO declaration on request
Contract & scheduled supply
A low-percentage excipient still stops a line when it runs out. 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 Croscarmellose Sodium
Chelora Chemicals is a supplier and sourcing partner, not a manufacturer. On a functional excipient used at 2%, 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 swelling behaviour actually matches your dissolution profile.
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. Changing a disintegrant source means repeating dissolution work, so we would rather you qualify the alternate in advance.
- Degree of substitution and settling volume checked batch to batch. These are the two numbers that predict performance, and we look at the trend rather than just the limit.
- We ask about your dissolution target. A fast-release and a modified-release formulation want different things from a disintegrant, and that shapes which source we go to.
- Compendial coverage confirmed first. 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 with the consignment.
- Moisture-protective packing as standard. This is a hygroscopic material whose whole function depends on unspent swelling capacity.
- 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
At a 2% use level a drum lasts a long time, which means the pack has to protect the material for months of partial use. Tell us how it will be charged at your end and we will quote the right format.
Fibre drums, double-lined
Double PE liner inside a fibre drum — the standard pharmaceutical format and the one that survives repeated opening.
Multiwall paper bags
Lined kraft bags on shrink-wrapped pallets for high-turnover users where each bag is consumed quickly.
Barrier packing
Aluminium-foil laminate sacks for humid destinations and long sea legs, where a PE liner alone is not enough.
Trial / sample quantities
Small sealed packs dispatched so your formulation team can run disintegration and dissolution trials before committing.
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 landing a year's usage at once.
Absorbed moisture is spent capacity
Croscarmellose is not classified as hazardous and is used in food as well as medicine. The handling discipline it needs is about performance rather than safety: every percent of moisture it picks up in your store is swelling capacity it will not deliver in the tablet. 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.HYGROHygroscopic — absorbed moisture reduces swelling performance.SLIPSpilled material becomes extremely slippery when wet.
The slip hazard is worth taking seriously. A wetted croscarmellose spill on a hard floor is as slippery as anything you will meet in a production area, and it is the one genuine safety point on an otherwise benign material. Always read the SDS issued with your specific batch.
Practical handling notes
- Clean spills dry, not wet. Water turns a minor spill into a slip hazard and a gelatinous mess — vacuum it up before washing the floor.
- Re-seal the liner immediately. Moisture pick-up is the single most common cause of a disintegration result drifting over a campaign.
- Mind blend uniformity at 2%. A superdisintegrant that is unevenly distributed gives tablets that disintegrate unevenly; sieve and pre-blend rather than dumping.
- Keep it out of the drain. It swells on contact with water and will block a trap.
- Bond and earth transfer equipment. The powder charges readily on pneumatic conveying.
Storage
- Cool, dry, tightly closed store. Humidity control matters here because the material's function depends on its remaining capacity to take up water.
- Keep the liner intact. A damaged liner on a slow-moving drum is a performance risk long before it is a contamination one.
- Keep off the floor and away from external walls. Condensation against a cold wall reaches the drum before it reaches the room.
- Segregate from strong acids. Acidic conditions convert the sodium form and change the swelling behaviour.
- Shelf life typically 36 months. In sealed original packing. Re-test LOD and settling volume before use 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.
- Sieve before blending. Fibrous powders can carry soft lumps that will not break up in a tumble blender.
- Watch blend time. Over-blending with a hydrophobic lubricant coats the fibres and slows disintegration measurably.
- Dedicated scoops and containers. Cross-contamination control matters more here than personal protection.
- Dispose of as ordinary non-hazardous waste. Subject to your local waste classification.
Transport
Croscarmellose sodium 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 degree of substitution, settling volume, LOD, pH, water-soluble material and salt limits against the monographs you cite.
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.
Crosslinks turn a thickener into a disintegrant
The same polymer, crosslinked, does the opposite job. Understanding why explains every specification on the COA. The steps below are the general industrial pattern, not a process disclosure.
Carboxymethylate cellulose
Alkali cellulose is reacted with monochloroacetic acid to build carboxymethyl groups onto the chain, giving Na-CMC.
Crosslink internally
Controlled conditions form crosslinks between chains, converting a soluble thickener into an insoluble, swelling fibre.
Wash and purify
Washing removes sodium chloride and sodium glycolate by-products down to the compendial limits.
Mill and classify
Drying and milling set the particle size distribution that governs blend uniformity at a 2% use level.
Why degree of substitution and settling volume predict performance
Two drums can both meet the monograph and still give different disintegration times:
- Degree of substitution sets hydrophilicity. More carboxymethyl groups means faster water uptake, but too many and the crosslinked network starts behaving like a gel.
- Settling volume is a direct proxy for swelling. It is the cheapest practical read on whether a batch will perform, and worth trending rather than just checking against the limit.
- Water-soluble material slows you down. The soluble fraction dissolves into a viscous layer that works against the disintegration you are paying for.
- Particle size governs blend uniformity. At 2% of the formulation, a coarse lot distributes less evenly and gives wider disintegration scatter across the batch.
That is why we trend degree of substitution and settling volume across batches rather than just checking the limit, and why the batch COA is shared for approval before dispatch rather than sent with the invoice.
| Material | Primary mechanism |
|---|---|
| Croscarmellose sodium CAS 74811-65-7 — this product | Wicking + fibre swelling |
| Sodium starch glycolate CAS 9063-38-1 | High-volume swelling |
| Crospovidone Crosslinked povidone | Capillary wicking |
| Low-substituted HPC CAS 9004-64-2 | Swelling with binding |
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.
Cellulose pulp cost
The chain starts from purified cellulose, so the dissolving-pulp market and its paper-sector competition feed through.
- Pulp tracks forestry and energy costs
- Monochloroacetic acid is the other input
- We flag feedstock-driven moves in the quote
Purification and washing cost
Getting sodium chloride and glycolate down to compendial limits takes extensive washing, and the water and effluent costs sit in the price.
- Washing is the main conversion cost
- Tighter salt limits cost more
- Contracted call-off smooths the exposure
Compendial coverage
A single-monograph 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
Freight and barrier packing
A low-density hygroscopic powder cubes out a container and needs real moisture protection on a long sea leg.
- Compare on landed, usable cost
- Specify the pack for the destination climate
- We quote FOB, CIF, CFR or DDP as you prefer
Source qualification lead time
Changing a disintegrant source means repeating dissolution work, so a supply gap costs far more than the spot price difference.
- We hold a second qualified source on this line
- Qualify the alternate before you need it
- Ask us about dual-source contracts
Generic launch cycles
A wave of generic launches raises demand for superdisintegrants across the industry at the same moment.
- Ask us what the market is doing
- Long-term contracts lock in supply
- We hold inventory on this line
| If your process is… | Start at |
|---|---|
| Direct compression | 2%, extragranular |
| Wet granulation | 3%, split intra- / extragranular |
| Roller compaction | 2–3%, mostly extragranular |
| Hard capsules | 2–4% of fill weight |
| Orally disintegrating tablets | 3–5%, with a second mechanism |
These are starting points for formulation work, not specifications. Describe your API, compression force and dissolution target and our technical desk will help you narrow them down.
Support that goes beyond shipping the drum
What our technical desk will do
- Ask about your dissolution target first. It is the question that decides whether croscarmellose is even the right disintegrant for your formulation.
- Confirm which pharmacopoeias you cite. Multi-compendial material costs more, and there is no point paying for tests your filing does not reference.
- Flag the lubricant interaction. Over-blending with magnesium stearate coats the fibres and slows disintegration — a common and avoidable scale-up surprise.
- 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.
- Sodium content can matter. On a low-sodium product, the sodium contributed by this excipient belongs in your calculation.
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
The pharmacopoeias you cite, any particle-size or settling-volume requirement, 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 disintegration 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 Croscarmellose Sodium
What is croscarmellose sodium used for?
How much should I use?
How does it compare with sodium starch glycolate and crospovidone?
Should it be added intragranularly or extragranularly?
Is it compliant with pharmacopoeial monographs?
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 Croscarmellose Sodium
Send the pharmacopoeias you cite, any particle-size or settling-volume requirement, 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.