Few chemical compounds have shaped modern medicine and industry the way Polyethylene Glycol 3350 has done. As far back as the mid-20th century, chemists started stringing together ethylene oxide units and stumbled upon versatile polymers that could move between cosmetics, pharmaceuticals, and industrial spaces without skipping a beat. PEG 3350 started as a humble thickener and plasticizer, but over the decades, its medical potential took center stage. From being a lubricant in machinery to becoming the backbone of bowel preparation for colonoscopies, this polymer has moved with the times. Only a handful of compounds earn a spot in both industrial toolkits and hospital supply rooms, underscoring PEG's versatility born from years of adaptation and regulatory scrutiny.
Polyethylene Glycol 3350 appears as a white, odorless powder that blends easily with water and stands out among its family for its specific molecular weight of around 3350 Daltons. In most pharmacies, PEG 3350 goes by names such as MiraLAX and GlycoLax, among others, under BP, EP, and USP standards. Institutions and suppliers gravitate toward it for its reliability in medical and manufacturing contexts. Its non-reactive nature and mild taste have made it the preferred choice for treating occasional constipation or acting as a stabilizer in various topical formulations. These attributes, alongside its impressive physiological inertness, keep it in continuous demand.
PEG 3350 does not just dissolve; it truly excels in aqueous environments. Water at room temperature welcomes PEG easily, where it forms clear, stable solutions without fuss. The powder resists volatility and does not encourage microbial growth, which reduces storage risks. A melting point that sits near 53-58°C and a density close to 1.13 g/cm³ translate into a compound that handles moderate processing conditions, making it a favorite in laboratories. Chemically, PEG 3350 keeps a straight chain backbone, making it rugged against common acids, bases, or oxidants. Over time, its robust hydrogen bonding and solubility predict its behavior in large-scale mixing tanks or tiny vials on a lab shelf.
Strict standards define what counts as BP, EP, or USP-grade PEG 3350. Pharmaceutical use demands low bioburden, narrow molecular weight distribution, and clarity in every parameter listed on the Certificate of Analysis. Testing for impurities such as ethylene oxide and heavy metals forms a non-negotiable part of approval, giving healthcare providers a benchmark for safety. Labeling gives detailed directions for storage—keep it cool and dry, shielded from sunlight—and provides batch numbers, grade indication, and purity level. Any deviation, and most regulatory environments will not tolerate its use in health care or food.
Industrial synthesis begins with polymerizing ethylene oxide under carefully controlled high-pressure, high-temperature conditions, using an initiator like water or ethylene glycol. The chain length, and thus the final molecular weight, hinges on how much initiator and monomer wind up in the reactor. Engineers then cool, neutralize, and sometimes pass the crude mixture through a purification process that could involve vacuum distillation or activated carbon filtration, to cut out undesirable byproducts and guarantee pharmaceutical-grade purity. Each step leaves a chemical fingerprint that is checked against pharmacopeial standards, since every deviation can influence how the polymer behaves in a clinical or industrial application.
PEG 3350’s backbone holds up to a string of chemical tweaks, turning it into a workhorse for conjugation in biotech. By activating terminal hydroxyl groups, researchers attach drugs, dyes, or proteins, which allow the compound to ferry molecules into the body or extend their circulation time. In tissue engineering, laboratories graft PEG derivatives onto surfaces to resist protein adsorption and cell adhesion. Modification often relies on tosylation or esterification to provide a “handle” for further functionalization, which opens doors to controlled-release therapies and safer biologics. These are not abstract exercises; every advance finds its way into the next generation of medicines or advanced coatings.
On the global stage, Polyethylene Glycol 3350 goes by a host of names and product labels, including Macrogol 3350, Carbowax 3350, and Polyaethylenglycol. Whether a label reads “PEG 3350” in an American clinical trial, or “Macrogol 3350” in a European hospital, the base chemical does not change. Marketing chooses the name, but regulatory bodies focus on molecular weight and purity. This tangle of synonyms often puzzles end-users, but clear labeling and harmonized international standards help limit confusion and guarantee that doctors and patients get the compound they expect.
Hospitals and manufacturers alike treat PEG 3350 as a known quantity, but that reputation rests on rigor. Safety data sheets confirm a low-toxic profile and epidermal compatibility, though accidental inhalation of dust or high-dose ingestion can bring on discomfort. Workplaces deploy simple, effective controls—labs use gloves, dust masks, and proper storage vessels to prevent accidental spills or degradation. Pharmaceutical operations specifically adhere to GMP guidelines, bringing audits and validations into the mix. Annual training forms the backbone of safe handling, supported by real-world incident reporting. These routines blend into daily work, proving that operational discipline supports public trust more than technological hype ever could.
Most people run into PEG 3350 at the pharmacy counter or in a hospital setting, often for constipation relief or before a colonoscopy. Clinical trials in my own region often rely on PEG-based formulations, since they avoid the harsh side effects associated with stimulant laxatives. Yet the same chemical properties that help patients clean out their bowels before a procedure make PEG 3350 valuable in tablet coatings, stabilizers, and ointment bases. Outside health care, factories use it as a mold-release agent, a plasticizer in adhesives, and a carrier for fragrances in personal care products. It is tough to overstate just how deeply PEG 3350 is woven into modern life, from critical medical interventions to the everyday products people use at home.
In laboratories, PEG 3350 acts as a baseline for innovation. Recent studies push its boundaries, looking at how PEGylated drugs can skirt immune detection or extend the half-life of cancer treatments and biologics. Work in material science uses PEG 3350 to design hydrogels with tailored release profiles, aiming for smart wound dressings that can adapt dosing based on patient need. My own collaborations with pharmacy faculty taught me that academic researchers treat PEG as a safe test bed for early-stage formulation work, especially when scaling up bench experiments to pilot runs. Grants funnel into modifying PEG chains to enhance bioavailability or reduce unwanted clearance, showing the depth of the compound’s ongoing story in the lab.
Studies find that PEG 3350 does not accumulate in the body, and most of it washes out without getting metabolized, making it well-suited for repeat or high-dose medical use. Subjects in toxicology trials report only mild gastrointestinal discomfort at very high intakes, and allergies are rare but closely watched. Long-term animal studies have not uncovered significant risks, bolstering confidence among health professionals who prescribe or administer PEG-based treatments. Water treatment systems even track PEG as a marker for wastewater, given its resistance to breakdown—proof of the compound’s durability outside the human body. Regulatory filings for new medicines re-examine toxicity with every new setting, making it one of the most scrutinized excipients in use today.
Looking ahead, PEG 3350 appears primed for deeper medical integration and broader industrial applications. Novel drug delivery vehicles, from gene therapies to nanoparticle suspensions, bank on PEGylation to provide stability and safety. At the same time, sustainability discussions have researchers eyeing greener manufacturing methods, possibly using bio-derived ethylene oxide or closed-loop recycling for process water. With breakthroughs in biologics and vaccine engineering, PEG derivatives could soon underpin therapies that reach smaller patient populations or treat rare and resistant conditions. In many academic and commercial circles, finding new uses for a trusted polymer like PEG 3350 remains a constant theme, as both the need for safe excipients and demand for improved material properties continue to drive research forward.
Polyethylene Glycol 3350, often known as PEG 3350, shows up in a lot of medicine cabinets. In hospitals and pharmacies, doctors and pharmacists rely on it every day. PEG 3350, as seen with the BP, EP, and USP grades, meets tough standards set by the British, European, and United States Pharmacopoeias. These global rules keep quality and safety tight. But what does PEG 3350 actually do, and why do folks keep asking about it?
Ask anyone who’s had chronic constipation or ongoing gut problems, and chances are PEG 3350 has come up. Laxatives with this ingredient bring relief by drawing water right into the colon, which softens stool and makes bathroom visits less stressful. For people taking painkillers, dealing with irritable bowel syndrome, or suffering from a slow digestive system after surgery, this simple solution changes daily life. PEG 3350 doesn’t irritate the bowels or create habits, a major plus compared to stimulant laxatives. Years of clinical focus back this up, with PEG 3350 showing solid results in both children and adults.
Beyond laxative treatments, PEG 3350 supports drug makers in surprising ways. Tablets, powders, and some syrups use this ingredient as a binder or stabilizer. It mixes easily, helps keep drugs together, and ensures each dose delivers the right amount of active ingredients. Pharmaceutical companies depend on it because it rarely triggers allergies and works in all sorts of pills and topical creams. PEG 3350 can even help mask bitter tastes, which matters to parents trying to medicate reluctant kids. Without it, pill production gets much trickier and more expensive.
PEG 3350 makes frequent appearances on safety lists for both pediatric and adult use. The U.S. FDA has accepted it as safe for over-the-counter sale, and European agencies monitor its ongoing safety. Tinkering with bowel movement frequency or consistency often brings risk, but PEG 3350 stays mild. Some people might see temporary bloating or cramps, but dangerous side effects stay rare. Pharmacists say, “Talk to your doctor,” especially if using it long-term, but most healthy folks find it reliable and easy to handle. As with any drug, informed use matters; too much of anything—even water—can cause trouble. But PEG 3350’s track record puts minds at ease for most families.
I’ve seen how chemical consistency shapes medicine quality. It’s not just about treating one symptom. Pharma companies test each batch of PEG 3350 to keep contaminants out and potency stable. A single unwanted impurity could ruin a whole line of tablets or open up health risks. Government regulators check samples regularly, and manufacturers respond swiftly to any concern. Years ago, I watched teams blend PEG 3350 with antibiotics to coat pills and control how fast medicine dissolves. Without that, some treatments lose their punch—or cause side effects because release comes too fast.
PEG 3350 answers a range of challenges that people face: digestive troubles, tough-to-swallow pills, and stable drug delivery. Some would like alternatives that work even gentler or rely less on synthetic chemicals. Scientists continue to test plant-based binders and osmotic solutions, but few match PEG 3350’s blend of safety and performance. Oversight and clear labeling keep trust high, but patient education can go further. Pharma companies and community clinics should keep talking openly about how and why ingredients like PEG 3350 work, not just what they treat. Honest, simple education saves more than just time in the long run—it puts control in the hands of patients and families who need it most.
Pharmaceuticals require certainty, especially with excipients like Polyethylene Glycol 3350, or PEG 3350. It’s a key player in products from laxatives to those used in tablet manufacturing, not just for how it dissolves but also because it doesn’t carry risks of contamination found in less pure chemicals. Unmatched consistency supports both drug safety and patient trust. Marks like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) tell pharmaceutical buyers that PEG 3350 hasn’t just been “made for pharma”—it’s been put to the test.
Nothing replaces a clear list when it comes to pharmaceutical ingredients. PEG 3350 should arrive as a white, nearly odorless powder or flakes, free from visible contamination. Pharmacopeias set precise molecular weight targets—normally around 3,150–3,850 daltons for USP standard. Water content must stay below 1% for BP/EP and under 1% for USP. A high water level can change the consistency and reactivity, putting patients at risk. Acidity and alkalinity tests make sure there’s no leftover catalyst or other reactive impurity; both BP and USP demand pH in a tight range, supporting stability in finished products.
The heavy metal specs reveal if a raw material producer took short-cuts. Pharma-grade PEG 3350 must meet limits for lead (less than 0.5 ppm), arsenic (below 2 ppm), and other toxic elements. Peroxide values should be low or undetectable because oxidized glycol can affect both drug shelf-life and patient outcomes. Microbial purity isn’t just a box to tick, it actually shows the product hasn’t been manufactured or stored in unsanitary conditions. Pharmacopoeias don’t allow coliforms, salmonella, or similar pathogens—this protects people with weakened immune systems, young children, and the elderly.
People outside pharma sometimes shrug off excipient specs, thinking active ingredients matter more. From experience in quality assurance, I know contamination by an excipient can derail a complete drug batch. For PEG 3350, purity standards run between 99.0% and 105.0% on anhydrous basis for BP/EP, and 92–100.5% for USP, accounting for allowable water. Unscrupulous suppliers may stretch limits or mislabel industrial grade chemicals. Every shipment must come with a certificate of analysis referencing batch and lot, and reputable suppliers back claims with regular audits.
Storage also plays a big role. PEG 3350 absorbs moisture from the air and can break down in sunlight or high heat, so manufacturers rely on robust packaging—airtight, non-contaminating, food-safe materials—to protect it. GMP (Good Manufacturing Practices) certification matters; a clean warehouse, trained staff, and batch traceability mean less chance of adulteration or recall.
It’s easy to look for the best price, but that move endangers patients and erodes trust in healthcare. Companies should develop direct relationships with certified suppliers and test lots in-house, not just accept supplier certificates at face value. Documentation needs electronic backup to prevent loss during audits. Routine sampling, regular supplier visits, and even investing in new testing instruments can reduce risk. Pharmacopoeias update standards frequently, and strict attention to these changes supports ongoing product quality. Patients might never know the name “PEG 3350.” But those of us working in pharma understand how high standards protect every person taking that medication.
Polyethylene Glycol 3350—often seen on pharmacy shelves as an ingredient in laxatives or as part of pill coatings—comes with strict labels like BP, EP, or USP to show it meets heavy standards. These stand for British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. In simple terms: the stuff in the bag or bottle matches a tough recipe trusted by authorities around the world.
Doctors trust PEG 3350 for a reason. The FDA in the U.S. and their counterparts in Europe have both greenlit it for many years. Walk into any pharmacy and you’ll find familiar brands relying on this very compound to treat constipation; not just for adults but for children too. Smart people in white coats put it through study after study. They looked for all sorts of problems—from allergies to long-term side effects. Most found that when used properly, PEG 3350 doesn’t cause big trouble. Minor side effects like mild bloating or cramps sometimes show up, just as they do with any laxative.
Pharma grade tags aren't just for show. These versions are cleaner and more stringently tested than what you’d find in industrial-grade chemicals. Labs check every batch for contaminants. Heavy metals, bacteria, or leftover solvents have no place in a raw material that goes into swallowing tablets. There’s paperwork trailing every shipment and audits keeping the suppliers honest. Drugmakers can trace which factory produced every scoop.
Not everyone thinks about what keeps a painkiller from crumbling in your hand or how a slow-release pill actually works. PEG 3350 keeps tablets stable and smooth, prevents clumping, and makes medicines easier to swallow. It shows up in injectables and creams for the same technical reasons. Get this wrong, and drugs could become unsafe or useless.
Cut corners on quality and real people get hurt. Industrial PEG not meant for medicine may sneak in impurities—sometimes toxic ones. Mistakes in manufacturing control can end up in recalls, lawsuits, and a loss of trust even if no one gets physically harmed. For those with rare allergies, even the safest bulk excipient might still trigger a reaction. No exaggeration: clean sourcing and regular tests protect everyone.
Medicine is never set-it-and-forget-it. Doctors, pharmacists, and patients all rely on a chain of trust. Governments and inspection agencies must keep their boots on the ground at factories and warehouses. Third-party labs can double-check random samples. More education helps patients recognize real, certified medicines and avoid fakes. If everyone on the supply side sticks with pharma grade, the risk drops. Honest labeling isn’t just paperwork; it’s a promise.
Storing raw materials in pharma work isn’t just about keeping shelves tidy. Polyethylene Glycol 3350, or PEG 3350, finds its way into labs and factories everywhere, each batch expected to stay just as stable and pure as the day it left the supplier. After years spent working in pharma production, one thing jumps out: even small lapses in how ingredients are handled can ripple through to patient safety and product quality.
PEG 3350 comes as a white powder or flakes, packed in drums or bags. In the heat of summer, stuffy warehouse conditions can turn a simple job into a challenge. PEG 3350 starts pulling moisture from the air when left exposed for too long. That subtle clumping might not look like much, but in the plant, uneven lumps slow down mixing and threaten consistency in finished goods. Pharmacopeias like BP and USP suggest storing PEG 3350 in cool, dry spaces. My own best practice sees this as more than a rule: aim for under 25°C and relative humidity below 60%. It doesn’t take fancy equipment—just diligent use of climate control and careful rotation of stock.
There’s always temptation in a busy plant to transfer materials into smaller bins or to leave bags half-open for the sake of convenience. Those shortcuts may save five minutes now but set up weeks of trouble later. I can recall batches lost after moisture crept into a drum left without its liner sealed tight. Packaging directly from manufacturers offers protection against light, dust, and contamination. Seal bags tight every time, and close drum lids before walking off. It’s simple, but so many incidents trace back to skipped steps like these.
Minimizing mistakes means paying close attention to every container’s label and documentation. Sometimes, staff with less experience overlook batch numbers or expiry dates. As someone who has sorted out audits and corrections, nothing helps more than clear, permanent, and visible labels. Good systems integrate barcode scanning and digital logs, cutting down on human error. When something does go wrong, traceability means faster investigations and fewer lost hours.
It’s never wise to treat pharma raw materials like ordinary warehouse stock. PEG 3350 must stay separated from other chemicals, especially volatile ones like strong acids and oxidizers. Accidental spills or fumes in shared storage can lead to cross-contamination, erasing the quality that users trust. Modern facilities follow zoning practices, but even smaller pharmacies or contract manufacturers benefit from simple measures—keep PEG 3350 off the floor, never under pipes, and away from windows or direct sunlight. Dedicated shelving helps, as does regular cleaning to prevent dust buildup.
Written procedures look neat in manuals, but habits shape what actually happens in real life. Training new employees isn’t just about reading documents; it’s about showing them how mishandling one drum affects entire supply chains. I’ve seen seasoned supervisors spend an extra minute checking seals, and that care trickles down. Staff who understand the stakes rarely take shortcuts. Regular reminders—posted signs, morning briefings, spot checks—help keep the importance fresh in everyone’s mind.
Using humidity indicators and moisture-proof containers can turn a routine into a safeguard. Conduct audits and encourage a culture where anyone feels comfortable speaking up if they spot unsafe storage. Technology like data loggers, while valuable, doesn’t replace the basics: a cool, dry store, sealed packages, and alert staff. These practical steps don’t just protect product—they build trust between manufacturers, regulators, and the people who rely on every final medicine.
Working in pharmaceutical supply runs you into a lot of questions about packaging, especially with ingredients like Polyethylene Glycol 3350 (PEG 3350) at BP, EP, and USP pharma grades. Anyone working in a small compounding pharmacy, a research lab, or even a large-scale tablet production line knows bulk drums don’t work for everyone. A small lab doesn’t want to store or afford a 25-kilogram drum, and neither does a pharmacy that mixes just a single batch per week.
Sourcing managers like clear answers on packaging. In practice, PEG 3350 pharma grade does show up in a spread of packaging sizes: from little pouches or jars of 500 grams to bags of 5 kilograms, all the way to drums or supersacks holding 25 or 50 kilograms. These aren’t just “marketing choices.” These sizes make a real difference for safety, workflow, and the bottom line.
Using the right size cuts down on waste. No one enjoys tossing out product because it expired halfway through a mammoth drum—or watching powder cake up after a bag’s been left open too long. Smaller packs help lower this risk. According to the United States Pharmacopeia and European Pharmacopoeia, once containers are exposed to air, moisture and contamination become a bigger threat. Opening a giant container for a modest batch? You run the risk of letting everything else spoil.
Sites that focus on personalized or low-volume medications benefit. They handle different prescriptions day in, day out, meaning they’d rather open up a 1-kilogram pouch for a precise mix than scoop out a little at a time from a huge bin. Smaller sizes keep product fresher and ensure compliance with procedures.
Major manufacturers can’t just pick any packaging—the material itself needs to be tested for leachables and extractables so nothing seeps into the PEG 3350 inside. Regulatory controls in the EU and US spell out exactly how containers and closures must function. Smaller packs also make it easier to track batch numbers and expiration dates, a must for auditing and recalls.
There’s a real push from buyers to only purchase quantities they truly need. The International Pharmaceutical Excipients Council (IPEC) frequently highlights demand for more sustainable, smaller packaging options in industry feedback. Less to store, less to dispose of, less up-front spending. Facilities that work with specialized medications—say, hospital compounding centers or clinical research units—feel this every day.
Digital supply chains now give buyers the chance to pick size at the point of order. I’ve seen procurement teams choose 5-kilogram resealable bags for monthly mixing, or allocate a 25-kilogram drum for bigger runs. Distributors are also catching up by holding more inventory in different formats, right down to single-use sachets.
Recycling and sustainability are still major pain points, though. Pharma-grade plastics aren’t easy to repurpose, and most labs don’t want residuals from old packaging. Some companies have started offering multi-layered bags that keep product safe and use less plastic overall. There’s also a shift toward biodegradable plastics, which could change the waste equation in a few years.
For buyers searching for Polyethylene Glycol 3350, packaging variety gives real flexibility. Labs, hospitals, and production plants get to work the way that suits them, protect quality, and handle safety or regulatory headaches without carrying unwanted weight. In a world that learns to never take logistics for granted, choice in packaging isn’t just nice—it’s necessary.
Names | |
Preferred IUPAC name | Poly(oxyethylene) |
Other names |
PEG 3350 Macrogol 3350 Poly(oxyethylene) glycol 3350 Carbowax 3350 Polyethylene oxide 3350 |
Pronunciation | /ˌpɒl.iˈɛθ.ɪ.lin ˈɡlaɪ.kɒl θriˈθaʊ.zənd ˈθrɪti ˈbiːˈpiː ˈiːˈpiː ˈjuːˈɛsˈpiː ˈfɑː.mə ɡreɪd/ |
Identifiers | |
CAS Number | 25322-68-3 |
Beilstein Reference | 1723206 |
ChEBI | CHEBI:61805 |
ChEMBL | CHEMBL1201520 |
ChemSpider | 85370138 |
DrugBank | DB09253 |
ECHA InfoCard | 03a020e3-78a3-4076-bd0e-4052d8ea09b3 |
EC Number | 200-849-9 |
Gmelin Reference | 45954 |
KEGG | C02315 |
MeSH | D020123 |
PubChem CID | 5745 |
RTECS number | MA0866000 |
UNII | MDQ269XTXL |
UN number | UN3082 |
CompTox Dashboard (EPA) | DTXSID8030045 |
Properties | |
Chemical formula | C2nH4n+2On+1 |
Molar mass | 3350 g/mol |
Appearance | White hygroscopic powder |
Odor | Odorless |
Density | 1.125 g/cm³ |
Solubility in water | Soluble in water |
log P | -2.0 |
Vapor pressure | <0.01 mm Hg (20°C) |
Basicity (pKb) | “pKb: 9.42” |
Magnetic susceptibility (χ) | -9.68×10⁻⁶ cm³/mol |
Refractive index (nD) | 1.335 - 1.338 |
Viscosity | 300 cP |
Dipole moment | 0.00 D |
Thermochemistry | |
Std molar entropy (S⦵298) | 247 J·mol⁻¹·K⁻¹ |
Std enthalpy of formation (ΔfH⦵298) | -589.3 kJ/mol |
Std enthalpy of combustion (ΔcH⦵298) | -25.5 kJ/g |
Pharmacology | |
ATC code | A06AD15 |
Hazards | |
Main hazards | May cause eye irritation. May cause slight skin irritation. Ingestion may cause gastrointestinal discomfort. Dust may cause respiratory irritation. |
GHS labelling | GHS labelling: Not a hazardous substance or mixture according to the Globally Harmonized System (GHS). |
Pictograms | Exclamation Mark |
Hazard statements | No hazard statements. |
Precautionary statements | Keep container tightly closed. Store in a cool, dry place. Avoid inhalation of dust or contact with eyes and skin. Use with adequate ventilation. Wash thoroughly after handling. |
Flash point | 113°C |
Autoignition temperature | 330°C |
Lethal dose or concentration | LD50 (oral, rat) > 20,000 mg/kg |
LD50 (median dose) | > 28,900 mg/kg (Rat, Oral) |
NIOSH | Not listed |
PEL (Permissible) | Not established |
REL (Recommended) | 10 mg/m³ |
Related compounds | |
Related compounds |
Polyethylene Glycol 400 Polyethylene Glycol 6000 Polyethylene Glycol 4000 Polyethylene Glycol 200 Polyethylene Glycol 1500 |