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Decades ago, scientists started looking for safe, reliable thickening agents to replace natural gums and starches in food and medicine. Cellulose, one of the most common organic compounds on earth, turned out to be a pretty good starting point. In the 1940s, researchers tinkered with cellulose, swapping some hydroxyl groups for carboxymethyl groups. This simple tweak gave birth to Sodium Carboxymethylcellulose (Sodium CMC). Pharmaceutical standards like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) eventually set the bar for purity and performance. These standards matter a lot to me in my own work because they make sure everybody’s playing by the same rules, and that’s crucial for anything intended for human use.
Sodium Carboxymethylcellulose BP EP USP pharma grade isn’t a one-trick pony. This compound thickens, binds, stabilizes, and suspends everything from liquid medicines to gels and topical creams. I remember walking down the pharmacy aisle, flipping over cough syrup bottles, and seeing this stuff quietly tucked away near the bottom of almost every label. It works well because it holds water while still being gentle on the stomach, and it’s never gone out of style thanks to this rare combination of qualities. For people who rely on precise dosages or have sensitive systems, a tried-and-true excipient like Sodium CMC offers a certain peace of mind.
Sodium Carboxymethylcellulose appears as a white to off-white fibrous or granular powder. It dissolves readily in cold or hot water, forming a clear, viscous solution. This property alone makes it a mainstay for pharmacists aiming to suspend insoluble particles. With a molecular weight ranging from 90,000 to 700,000 Daltons depending on substitution and polymer length, it gives manufacturers plenty of control over the texture and viscosity of final products. The sodium salt form ensures it dissolves better in water than pure cellulose ever could, opening doors for use in liquid formulations and semi-solids. Its pH usually hovers between 6.0 and 8.5 in a 1% aqueous solution, keeping it compatible with sensitive biologics and actives.
British, European, and United States standards insist that pharmaceutical grade Sodium Carboxymethylcellulose stays exceptionally clean — free of heavy metals, microbes, and other harmful contaminants. Moisture content typically goes below 10%. Manufacturers stamp every batch with its substitution degree, viscosity range, and the exact pharmacopoeial standard met. I’ve spent hours checking certificates of analysis versus these standards, because one slip can mean a recall or worse, an adverse reaction in patients. The label has to show more than just the grade: additive codes, allergen status, and source materials (often wood or cotton) come with each shipment.
The journey starts with high-purity cellulose derived from wood pulp or cotton. The cellulose gets steeped in alkali, then treated with monochloroacetic acid. This reaction swaps certain hydrogen atoms on the cellulose for carboxymethyl groups, creating a sodium salt when neutralized. The reaction doesn’t always run perfectly, so manufacturers fine-tune pressure, temperature, and time until the degree of substitution lands inside strict limits. This step shapes the viscosity, solubility, and dispersibility of the final product. After stringently washing, drying, and grinding the new compound, only then does it earn a BP, EP, or USP stamp.
Not all Sodium CMC is created the same. Chemists can tweak the degree of carboxymethyl substitution, adjusting the chain length and sodium content for each application. This one modification lets the compound gel, thicken, or even form films. Cross-linking agents build stronger molecular networks for slow-release tablets. For controlled-release or gastric-protected tablets, attaching other functional groups changes how it dissolves and interacts with active ingredients. Some labs even attach hydrophobic moieties to improve compatibility with oily active ingredients. These modifications usually happen with careful monitoring in good manufacturing practice (GMP) facilities because small changes at the lab bench can echo loudly in the human body.
Over the years, Sodium Carboxymethylcellulose has gathered a glossary of alternative names: CMC-Na, cellulose gum, and E466. You’ll spot these on ingredient panels throughout food, pharma, and personal care. Pharma grade CMC rarely carries a brand label in finished products, but raw material vendors mark their lots with company trademarks to trace the manufacturing source. Trade names sometimes specify viscosity, mesh size, or country of origin—a must for those relying on consistent results in highly regulated settings.
Strict manufacturing practices limit bacteria, endotoxin, and heavy metals. Reputable suppliers keep endotoxin levels below 0.25 EU/mg for parenteral use. Cross-contamination gets blocked through dedicated clean rooms and processing lines. In my view, no shortcuts can exist in these operations—one contaminated drum can shut down a factory. Personnel handle Sodium CMC with gloves and masks, especially in facilities where polymers dust easily, to avoid inhalation or skin irritation. Regulatory agencies, including the FDA and EMA, review toxicology data regularly and demand updated Good Manufacturing Practice (GMP) certification for plants making pharma grade excipients.
Doctors, scientists, and engineers reach for Sodium CMC in almost every corner of medicine and beyond. Oral suspensions, eye drops, wound dressings, and gel-based tablets rely on its soothing texture and stabilizing power. A friend with dry eyes once showed me a bottle of artificial tears — Sodium CMC gave those drops the extra viscosity needed to linger on the eye’s surface. In tablets, it acts as a binder and disintegrant to make pills break apart evenly. Injectable drugs employ ultra-clean, low-endotoxin CMC to thicken without triggering immune reactions. Away from medicine, toothpaste makers use it to keep pastes from weeping, and even painters use it to manage the flow of water-based colors.
Research in this field rarely stands still. With stricter regulations and more complex therapies, R&D labs now push for CMC grades with better purity, greater batch-to-batch consistency, and tailored molecular profiles. Scientists study how CMC interacts with biologics, peptides, and nanoparticles. Others focus on new cross-linking chemistry for sustained drug release. In recent years, attention has turned to making sodium CMC from renewable cellulose sources, reducing reliance on petrochemicals and making supply chains more sustainable. Transparency efforts include blockchain batch tracking and tighter analytical testing so every shipment meets label claims. Pharma companies fund joint projects with universities to unlock new uses—like targeted drug delivery and antimicrobial hydrogels.
Toxicology studies back up the long-standing use of Sodium CMC as a low-toxicity excipient. Animal studies and clinical data consistently show it passes through the gut unchanged, rarely absorbed into the bloodstream. Tests reveal no mutagenic or teratogenic risks at the levels used in medication, although ultra-high doses can act as a laxative. During my own reviews of safety data, I noticed that regulatory authorities occasionally request new studies to address infant and elderly populations, but so far, most evidence supports its continued use without major restrictions. Allergic reactions remain vanishingly rare, a real benefit for vulnerable patient groups.
Demand for advanced formulations will keep Sodium Carboxymethylcellulose in sharp focus. Pharma needs gels that deliver drugs more precisely, eye drops that linger longer, and tablets smart enough to respond to body chemistry. Researchers hope to blend CMC with nanomaterials or biologically active agents for wound healing, cancer therapy, and tissue engineering. I see more pressure for eco-friendliness, which could nudge manufacturers toward greener synthesis and biodegradable alternatives. As drug molecules get delicate and more personalized, consistent, high-purity excipients like Sodium CMC will probably only grow more important. Better traceability systems, tighter analytics, and certified sustainable sourcing could define the next generation of pharma grade excipients.
Sodium carboxymethylcellulose (CMC) might not sound familiar to most people, but if you’ve ever swallowed a tablet or opened a bottle of cough syrup, you’ve probably come across it. I’ve watched pharmacists handle hundreds of products, each demanding reliability and safety. This chemical steps in as a crucial helper behind the scenes.
Pharma grade CMC isn’t just a filler. Its main strength lies in how it helps shape and stabilize almost every kind of oral medication. Companies use it to give tablets their strength, making sure each pill keeps its form right up until it’s taken. Picture chewing a chalky tablet; bits break apart where they shouldn’t. Manufacturers add CMC so tablets won’t crumble before they’re supposed to, surviving bumpy rides and storage—even the humidity of a summer’s day.
Medicinal syrups and suspensions lean on Sodium carboxymethylcellulose for their texture. Kids won’t take runny medication that separates into layers, so keeping mixtures smooth matters just as much as flavor. I’ve seen syrups thicken just enough with a pinch of CMC, making dosing more accurate for parents and patients. Dry powders that need to mix effortlessly into water benefit too; the chemical helps create a solution where every sip contains the right amount of medicine.
The pharma-grade label signals tight quality control. Not all CMC is made equal. The best grades for medicine meet global standards set out in the British Pharmacopoeia (BP), the European Pharmacopoeia (EP), or the United States Pharmacopeia (USP). These bodies ask for purity and safety levels that food-grade or industrial CMC can’t reach. Mistakes in ingredient sourcing can cause allergic reactions and medication imbalances, so doctors and patients trust only proven suppliers who work within strict guidelines.
CMC carries a reputation for being gentle on the body. Doctors prescribe medicines to the youngest children and the most sensitive patients, so inactive ingredients must not set off allergies or irritate the stomach. CMC has a long record in oral, topical, and even eyedrop medications. For anyone with dry eyes, those artificial tears owe their soothing effect to the way CMC holds water right against the eye, reducing discomfort for hours.
The pharmaceutical world also leans on CMC for coating medical devices and binding together powders for inhalers. Science journals report CMC’s ability to create hydrogels—soft and flexible delivery systems for wound care or gradual drug release. This helps avoid sudden, harsh doses and gives more predictable outcomes.
Pharmaceuticals keep searching for safer, friendlier ingredients. Solutions include more investment in traceability, so patients always know where their inactive ingredients come from. Third-party audits and certification build trust, closing the gap between what the label promises and what the patient receives. More manufacturers turn to greener, sustainable methods for producing CMC, reducing environmental impact and reassuring health-conscious consumers.
No magic lies in any single ingredient, but Sodium carboxymethylcellulose pharma grade earns its place through consistency, safety, and a proven record across the world’s most trusted medicines.
Sodium carboxymethylcellulose, or CMC, isn’t the kind of name that calls to mind home remedies or herbal medicine. Made by chemically altering plant cellulose, CMC serves as a thickener, stabilizer, or binder in plenty of prescription tablets, liquid syrups, and topical gels. Pharmacists have worked with this material for decades, and CMC keeps cropping up in medication labels, toothpaste tubes, and even some eye drops.
Regulatory agencies like the US Food and Drug Administration and the European Medicines Agency both consider sodium carboxymethylcellulose safe for use at recommended levels. Over the years, scientists have studied CMC quite closely. They’ve looked at everything from how it breaks down in the body to what happens when it stays on the skin. Researchers haven't found strong evidence linking typical amounts with serious harm.
In my own experience behind a pharmacy counter, I’ve seen parents raise eyebrows at mysterious ingredients, worried about what’s actually in those bottles. With CMC, serious side effects have always been rare. Even in high-dose animal studies, reactions like digestive discomfort or mild allergic responses only turned up in cases of massive overconsumption—doses nowhere close to what a pill would bring. Most people, even those with sensitive stomachs, don’t report much of a problem.
The story takes on more weight when looking at the general population. Many processed foods use similar cellulose-based additives, so it’s not just folks on multiple prescriptions who encounter it. Our bodies can’t really digest CMC, and most gets flushed out through the gut. Some people have speculated about possible gut health effects, especially for those who eat large amounts of food-grade CMC. Studies haven’t shown consistent long-term harm.
Children, older adults, and those living with certain medical conditions deserve extra care. They might react more strongly to many things—not just sodium carboxymethylcellulose. For people with tough digestive issues or a history of allergies, doctors tend to watch for any negative responses, but these are exceptions rather than rules.
One thing that gives me confidence in the use of CMC: drug manufacturers stick to high standards. The CMC used in medicine comes with tighter controls than what’s found in paint or industrial adhesives. Safety tests, purity checks, and precise measurements leave little room for guesswork or cross-contamination.
Label transparency matters too. Consumers deserve honest ingredient lists that spell out what’s in their prescriptions. Every pharmacist I know appreciates phone calls from people checking out new medications—skepticism can be healthy. By sharing published facts and clear safety records, the industry builds the kind of trust that doesn’t just rest on authority.
That doesn’t mean sodium carboxymethylcellulose will always reign supreme. Newer delivery forms and natural alternatives continue to get attention in laboratories. Plant-based gels, starches, and gum derivatives show promise for anyone wanting something closer to nature without missing out on reliability. Change takes time, especially in a field where one bad batch could shut things down, but innovation is constant.
Right now, with data stretching back decades and layers of oversight, sodium carboxymethylcellulose stands as a familiar part of the pharmaceutical toolbox. Real trust comes from ongoing vigilance and listening to patient concerns—never from assuming any ingredient is beyond questioning.
Working in the pharmaceutical field, I’ve seen how tiny differences in raw material standards can create big challenges during development. Sodium Carboxymethylcellulose, better known as CMC, acts as a thickener, stabilizer, and a binder across medicine, food, and cosmetics. The grade—whether BP (British Pharmacopoeia), EP (European Pharmacopoeia), or USP (United States Pharmacopeia)—spells out how pure and reliable this ingredient should be before it ends up in a patient’s medicine or someone’s daily lotion.
Every pharmacopoeial grade expects CMC to check off a long list of boxes: content, purity, appearance, and safety limits for metals and microbes. For example, each standard sets a minimum carboxymethyl substitution, usually between 0.6 and 1.0 per glucose unit—measured to control viscosity and chemical activity. Products with too low a substitution won’t function as expected in tablets or suspensions; too high and processing becomes difficult.
Water content must not exceed about 10%, as excess moisture invites spoilage or unwanted reactions. Pharmaceutical standards tightly control this aspect; exceeding limits can mean batches go to waste. Sodium content also matters—a BP/EP/USP grade keeps sodium between about 6.5% and 9.5% to ensure solubility without causing instability in the final product.
In my experience, any risk from toxic metals—like arsenic, lead, or cadmium—draws out strict scrutiny. BP, EP, and USP all cap heavy metals, usually at 10 ppm or less, making sure everyday users never face accidental contaminants. Microbial limits, too, stay stringent; total aerobic microbes often must fall under 1000 colony-forming units per gram, with many standards demanding even tighter limits for oral products.
Labs and factories have to back up every claim with documentation: certificates of analysis, batch traceability, and analytical methods in line with pharmacopoeial guidelines. Years of sourcing excipients have shown me that some suppliers cut corners by blending lower-purity CMC, especially in less regulated markets. Without clear traceability, safety gets compromised. Genuine BP/EP/USP CMC often costs more, but it delivers that peace of mind everyone relies on, from doctor to patient to regulator.
Color, odor, and solution clarity also turn up as defining checkpoints. USP describes CMC as a white to almost white, odorless powder. Off-color or musty batches tell you something’s gone wrong. Confirming each parameter with physical checks and lab analysis keeps bad material out of the process early on.
Teams should always run wet chemistry and advanced instrument analysis—like FTIR and NMR—to confirm there’s no unwanted polymer or by-product sneaking in from poor manufacturing. Bringing supplier audits into the workflow, combined with tough pre-approval testing, widens the barrier to low-grade product finding its way into final medicines.
I’ve seen how chasing the lowest price instead of the highest standards backfires. Even one batch failing purity requirements can stall a launch or trigger recalls, causing months of lost work. It’s better to push for robust documentation, regular site visits, and active conversations with suppliers. Many major companies now insist every CMC shipment aligns with BP, EP, or USP requirements and include batch-specific analytical results as part of each order.
Moving forward, combining advanced quality systems and regulatory diligence protects both the industry and the consumer. For any pharmaceutical or food product to be safer and more predictable, sticking to BP/EP/USP standards for CMC isn’t just regulatory red tape—it’s the core of building real-world trust.
Sodium Carboxymethylcellulose, whether labeled BP, EP, or USP, shows up in labs, food processing plants, and pharmaceutical manufacturing on a daily basis. Over the years working around production lines and quality rooms, I've seen teams pay the price for carelessness with sensitive materials like this one—clumping powders, lost batches, headaches over failed quality checks. Solutions start at the storage shelf. This chemical has a reputation for attracting moisture right out of the air. Humidity creeps in, and soon you've got lumps no mixer can fix. So, keeping it in sealed containers carries more weight than just following protocol—it's how you protect both the integrity of the product and the money tied up in inventory.
I’ve kept samples of Sodium Carboxymethylcellulose in everything from double-layered bags to rigid plastic tubs. No matter the scale, dry conditions matter most. Environment controls earn their keep in hot summers and rainy seasons alike. Leaving open bags, even for a short time, often leads to product breakdown or contamination that rarely shows up right away. Any exposure to high humidity not only triggers caking but can encourage microbes to grow. This is especially important for pharmaceutical batches where even minor contamination will cause failed tests and recalls. I’ve met too many technicians who wished they’d just zipped up the container.
Taking shortcuts, like leaving product unrefrigerated in tropical conditions or stacking containers near a heat vent, never goes unnoticed for long. I recall one week in a tropical plant where heat and dampness seeped into a shipment because of poor warehouse checks. Bags had popped, powder clung to every surface, and the cleanup took a whole team’s weekend. Simple steps would have avoided the chaos—tight seals, keeping storage areas cool and dry, and clear labeling. Good habits matter more than any sheet of written procedure.
Keep Sodium Carboxymethylcellulose in airtight, opaque containers. Store in places shielded from direct sunlight, with temperature swings held in check. Unlike some ingredients, this one stays stable longest in cool, dry spaces. Big operators use dehumidifiers and air conditioning for a reason. Workers benefit too—powder floating around makes a mess of the air and your lungs. I’ve learned that glove use and even simple dust masks create safer workplaces and cut down on accidental exposure. No one likes sneezing through a shift because somebody got sloppy with the powder scoop.
Sharing what actually works—double-sealing, periodic inspections, not relying on luck—boosts your reliability as a supplier or a lab tech. Inspecting storage spots every few days means off-odors, condensation, or pest presence never catch you by surprise. As more companies tighten standards for food and drug safety worldwide, handling ingredients with care isn’t just about ticking boxes; it keeps businesses running smoothly, keeps customers healthy, and protects everyone on the job from avoidable risks. Doing it right the first time always beats scrambling to fix mistakes later.
A big part of working with chemicals like Sodium Carboxymethylcellulose—let’s call it CMC for short—is trusting what’s in the drum, bag, or box. These days, questions about documentation pop up all the time. Everyone from manufacturers to food brands and even local bakeries need to know what’s really inside—and that’s where things like COA, MSDS, and regulatory compliance come in.
A Certificate of Analysis (COA) offers a breakdown of product quality and consistency. Years in food and pharma have taught me that having a COA helps you catch problems before they spiral. For CMC, the COA lists purity, viscosity, pH, moisture, and maybe sodium content. Real results get matched with established specs. For example, if your bread dough needs CMC with a certain viscosity, that number better fall where you expect it. A missing or vague COA has often turned into delay, rejected shipments, and a lot of unhappy phone calls.
Material Safety Data Sheets (MSDS), or sometimes just SDS now, can look like a pile of legal jargon. They become gold in a crisis. If you’ve ever dropped a bag of powder in a small room, you know the panic until someone checks the dust hazard section. CMC is considered safe for many uses but inhaling the fine powder, mishandling bulk bags, or improper cleanup does real harm. The MSDS brings the facts—hazards, first aid guidelines, storage instructions, and what to do if something goes wrong. Safety training always improves when staff can pull up the actual paperwork instead of guessing.
Regulatory compliance goes deeper than paperwork; it’s essential if you want to sell or use CMC in regulated settings, like food, pharma, or cosmetics. Different countries handle CMC differently. For example, in the US, the FDA checks it as a food additive, while in Europe, E466 gets scrutiny under food law. Exporters and importers need up-to-date paperwork that fits the target market’s demands. I’ve seen orders seized at customs because certificates or registration numbers didn’t line up with local rules. Even technical points—who makes the CMC, country of origin, production process—can make or break deals.
Customers ask for COA, MSDS, and regulatory docs for good reason. Product recalls can cost millions. Small manufacturers suffer the most without proper backup. In my daily work, trust between buyer and seller depends largely on whether paperwork stands up to scrutiny. When suppliers update their documents regularly and answer questions upfront, stress goes way down. Teams work better, less blame gets thrown around, and products land on shelves or in patients’ hands faster.
Keep documentation accessible. Don’t just file it in a dusty folder or hide it on an old hard drive. Train staff to check every shipment, not only when a problem comes up. Work with suppliers who treat documentation as a routine part of business, not an afterthought. Push for digital systems for tracking and storing files—email attachments get lost, and paper copies disappear.
In an industry that moves fast and never forgives errors, the right paperwork keeps business on track. COA, MSDS, and compliance certificates aren’t just formalities. They shape everyday safety, reputation, and reliability in every shipment of CMC.
| Names | |
| Preferred IUPAC name | Sodium 2-(carboxymethoxy)ethyl cellulose |
| Other names |
Carboxymethylcellulose Sodium CMC Sodium Sodium CMC Cellulose Gum Sodium Salt of Carboxymethyl Cellulose E466 Na-CMC |
| Pronunciation | /ˌsoʊdiəm kɑːrˌbɒksimˌiːˈθɪlˌseljuːˈloʊs/ |
| Identifiers | |
| CAS Number | 9004-32-4 |
| Beilstein Reference | 3568738 |
| ChEBI | CHEBI:85191 |
| ChEMBL | CHEMBL1201472 |
| ChemSpider | 86521 |
| DrugBank | DB09487 |
| ECHA InfoCard | echa.infocard.100.031.838 |
| EC Number | 9004-32-4 |
| Gmelin Reference | 11393 |
| KEGG | C01051 |
| MeSH | D02.705.400.625.800 |
| PubChem CID | 86650473 |
| RTECS number | BO2625000 |
| UNII | 7OSW39S2T8 |
| UN number | UN3077 |
| CompTox Dashboard (EPA) | DTXSID2044375 |
| Properties | |
| Chemical formula | C6H7O2(OH)2OCH2COONa |
| Molar mass | 262.19 g/mol |
| Appearance | White or almost white powder |
| Odor | Odorless |
| Density | 0.5 – 1.0 g/cm³ |
| Solubility in water | Soluble in water |
| log P | -5.1 |
| Acidity (pKa) | Acidity (pKa): "3.5 - 4.5 |
| Basicity (pKb) | 6.5 - 9.0 |
| Magnetic susceptibility (χ) | Diamagnetic |
| Refractive index (nD) | 1.33 |
| Viscosity | Viscosity: 5 to 5000 cps |
| Dipole moment | 0 D |
| Pharmacology | |
| ATC code | A04AD11 |
| Hazards | |
| Main hazards | May cause eye, skin, and respiratory tract irritation. |
| GHS labelling | GHS07, GHS08 |
| Pictograms | GHS07, GHS08 |
| Signal word | Not Hazardous |
| Hazard statements | Not a hazardous substance or mixture according to the Globally Harmonized System (GHS) |
| Precautionary statements | Precautionary statements: P264, P280, P305+P351+P338, P337+P313 |
| NFPA 704 (fire diamond) | 1-0-0 |
| Explosive limits | Not explosive |
| Lethal dose or concentration | LD50 (oral, rat) > 27,000 mg/kg |
| LD50 (median dose) | > 27000 mg/kg (rat, oral) |
| NIOSH | SCB7600000 |
| PEL (Permissible) | PEL (Permissible Exposure Limit) for Sodium Carboxymethylcellulose: Not established |
| REL (Recommended) | 30 mg/kg |
| Related compounds | |
| Related compounds |
Carboxymethylcellulose Cellulose gum Hydroxypropyl cellulose Microcrystalline cellulose Methylcellulose Ethyl cellulose Sodium alginate Guar gum Xanthan gum Pectin |
Chengguan District, Lanzhou, Gansu, China
