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Polyethylene Glycol 2000 BP EP USP Pharma Grade: Deep Dive

Historical Development

Long before chemists learned to unravel polymers for today's complex medicines, Polyethylene Glycol (PEG) quietly emerged in diagnostics and drug delivery. Early in the 20th century, researchers realized simple glycols could blend water solubility with chemical stability, but the real momentum picked up after World War II. By the 1960s, pharmaceutical companies had recognized PEG’s value for pill coatings, especially as stricter purity standards forced formulators to turn away from impure or unstable alternatives. PEG 2000 now anchors countless lab protocols: it bridges traditions of postwar chemistry and fresh biotech innovation.

Product Overview

PEG 2000 in pharma grade form doesn’t just serve as an ingredient; it brings reliability to every batch. Most white and waxy, it carries a mild odor and melts below human body temperature, making it easy to handle in both powder and liquid systems. Its ease in mixing with both water and a range of organic solvents helps it find a home in medications, creams, and injectables. Manufacturers lean toward this grade since it responds well to both hot-melt and solvent processes, keeping production lines humming in facilities from Europe to Asia. Under the banners of BP, EP, and USP standards, it clears the tightest purity thresholds, staying free from heavy metals and toxins.

Physical & Chemical Properties

PEG 2000 sits as a midpoint between lighter PEGs, which pour like syrup, and heavier ones, which feel solid. Its average molecular weight hovers close to 2000 daltons. Water welcomes it readily, but it also partners with ethanol and acetone. The molecule’s backbone offers a stable chain of –CH2CH2O– units, which gives it flexibility and low toxicity. Boiling points land well above 200°C, and the melt transition just around room temperature. PEG 2000 resists breakdown by common acids and bases. In my own experience with lab-scale preparations, the minimal reactivity simplifies cleaning, reduces hazardous byproducts, and lets technicians focus on accuracy rather than fear of contamination.

Technical Specifications & Labeling

Pharma-grade PEG 2000 ships in drums or lined bags, usually labeled with batch number, expiration date, and purity percentage—often 99% or higher, with strict caps on heavy metals like lead or arsenic, sometimes below 1 ppm. Processors routinely check for color using APHA standards, and residual solvents must meet clear European Pharmacopoeia or USP safe limits. These specs aren’t just red tape: they keep patients as safe as possible, since PEG works as a carrier for medicines that the immune-compromised or allergic eventually take. Operational guides demand clear storage instructions, usually in sealed containers away from moisture.

Preparation Method

Factories create PEG 2000 through the polymerization of ethylene oxide, using a special initiator like water or glycol itself, and tracking the chain length by temperature and pressure control. The process allows operators to nudge the average molecular weight into the goldilocks zone around 2000. Anticipating the strictest GMP audits, most pharma lines operate with closed systems and frequent purity checks. The reaction uses no exotic catalysts, but scrubbing the final product for unreacted monomer matters most, especially in parenteral drugs. Filtration, back-extraction with solvents, and other post-processing steps try to protect end users from rare but dangerous alkylene oxide residues.

Chemical Reactions & Modifications

PEG 2000’s chief virtue isn’t its chemical inaction, but how easily labs and manufacturers bolt on new side groups. Chemists take advantage of the terminal hydroxyls, hooking on amines, carboxylic acids, or peptides. In drug development, attaching PEG chains to biologics via “pegylation” can slow clearance, shield sensitive protein regions, and soften immune reactions—a trick that has transformed many modern medicines. PEG 2000’s reliability means each modification behaves predictably across multiple batches, which matters when every microgram in a biotech vial must match tight protocols from Frankfurt to Tokyo. I’ve watched graduate students and process engineers alike swap in PEG modifications to keep biosimilar timelines on track and avoid costly restarts.

Synonyms & Product Names

Across literature and packaging, PEG 2000 goes by other names, like Macrogol 2000, Carbowax 2000, or Polyox 2000. Registrations and regulatory filings may list synonyms to avoid confusion, especially for customs and hazardous transport documentation. Pharmacopeia listings distinguish it from both lighter and heavier PEGs, since mixing weights leads to unpredictable melting points, solubility, or drug release rates. Checking for these names during procurement avoids costly ingredient mix-ups.

Safety & Operational Standards

Handling PEG 2000 rarely brings surprises in a manufacturing or R&D setting. Both EU and US guidelines urge gloves, goggles, and dust control when pouring or heating, since fine particulates irritate eyes or lungs over time. While not classified as carcinogenic, inhaling the powder risks respiratory issues if standards slip. Storage in cool, dry places prevents mold or off-odors, while regular testing guards against long-chain degradation. Waste systems collect PEG residues according to regional best practices, as any glycol in high doses strains water treatment plants. Over the years, operations with tight hygiene protocols report few serious safety events, but monitoring never stops.

Application Area

Pharma-grade PEG 2000 plays a quiet, crucial role behind the scenes. Tablet coatings, capsules, ointments, and even veterinary injections rely on it to keep medicines at the right consistency. PEG 2000 helps solubilize active drugs, especially newer proteins or poorly soluble molecules. In mRNA vaccines, PEGylated lipids hold the shot together from freezer to muscle. Beyond medicine, personal care products—creams, lotions, some toothpaste—take advantage of its blendable texture and skin compatibility. Some diagnostic reagents use it as a stabilizer or viscosity modifier. Industrial research often pushes into new uses for PEGs by tweaking the chain length, but 2000 lands firmly in the medical and biotech camp.

Research & Development

Universities and industrial labs continue to push PEG 2000 into new territory. Drug delivery teams investigate it for both oral and injectable medicines, tweaking “pegylation” strategies to reduce dosing frequency. Analytical chemists develop better tests for trace monomer byproducts, ensuring the safest profiles for patients. Innovation rarely stops: recent years have seen PEG 2000 used as a scaffold in nanomedicine, targeted cancer therapies, and solvent-free tablet manufacturing. Toxicologists and immunologists work hand in hand to track rare but significant allergies, spreading awareness for both doctors and production teams.

Toxicity Research

PEG 2000 has a long record for low toxicity at doses found in medicine and cosmetics. Most humans excrete it unchanged in urine within hours, meaning it seldom lingers to cause damage. Rare allergic reactions prompt some cautious labeling, especially after a small number of incidents related to vaccines and injectable biologics during the last few years. Animal data points to high margins of safety, though high, repeated doses can stress kidneys or cause gut upset. Regulators keep close watch on trace impurities, particularly ethylene oxide or dioxane, which pose higher risks than PEG itself if allowed to accumulate. My own work with toxicologists has always boiled down to vigilance in sourcing and rigorous supplier audits.

Future Prospects

PEG 2000 stands ready for a new era as precision medicines and personalized drugs take the spotlight. Researchers look to improve its biodegradability, aware that traces in water systems add up over years, prompting calls for “greener” alternatives or more selective breakdown triggers. Drug approval agencies will likely increase scrutiny for impurities and allergens, while the broader public grows more curious about inactive ingredients in injectables. Pharmaceutical supply chains depend on robust and reliable inputs, and manufacturers who keep pace with evolving standards will find PEG 2000 remains a frontline ingredient, especially as more therapies enter the market demanding consistent, reproducible performance. The next decade brings opportunities for molecular customization, sustainable chemistry, and allergy screening—all rooted in this one, unassuming polymer.




What is Polyethylene Glycol 2000 BP EP USP Pharma Grade used for?

Common Ground in Pharma Manufacturing

Walk into any modern pharmaceutical factory, and you’ll find one familiar workhorse: Polyethylene Glycol 2000, or PEG 2000. This isn’t just one of those chemical names you hear and forget. It sits in blister packs, tablets, creams, and even vaccines. PEG 2000, made to the strictest BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) standards, plays a bigger role than most realize.

Reliable Base for Medicines

PEG 2000’s biggest contribution comes from its consistency. Scientists and quality teams demand the same result every time, and PEG 2000 delivers. In solid tablets, manufacturers add it to allow powders to stick together and hold their form. This makes tablets easier to swallow, less likely to crumble, and more precise in delivering the right amount of each ingredient.

Pharmaceutical companies trust PEG 2000 because of tight quality controls. Those BP, EP, and USP grades aren’t just letters for marketing—they reflect a global agreement about purity and safety. My own introduction to PEG 2000 came during an internship at a generic medicine plant. Quality experts would inspect every container brought in, rejecting anything that didn’t match their strict standards. PEG 2000 that’s not up to grade never enters production; lives depend on it.

Medicines Go Further with PEG 2000

Not all ingredients mix well with water or oil. PEG 2000 solves that problem; it helps oily medicines dissolve, making treatments more effective. Doctors count on this for ointments, creams, and even for injectable medicines. During the COVID-19 pandemic, vaccine makers faced a unique problem: delivering new mRNA into cells. PEG 2000 acted as a stabilizer in the lipid nanoparticles that carried the active vaccine through the body. The trust in this compound grew even stronger, though it also made headlines for allergy risks, a reminder that even common ingredients need careful oversight.

Gentle Option in Laxatives and Other Treatments

For those dealing with digestive issues, doctors often prescribe laxatives based on PEG 2000 because it draws water into the intestines, making stool softer and easier to pass. Unlike harsher treatments, PEG-based solutions work gently—something many families, including my own, have come to appreciate for their reliability and safety.

Safety Through Transparency

Consumers and healthcare professionals both want to know what’s in their medicines. PEG 2000’s role is always listed in the ingredient section. Pharmaceutical suppliers and regulators track every batch to make sure it meets established purity standards. Even as new medication forms and delivery methods appear, the core demand—showing that substances are high-quality and safe—never fades.

Better Practices for a Safer Future

Pharma companies keep searching for ways to minimize allergic reactions, provide full disclosure, and improve sourcing. As someone who’s seen both patient concerns and manufacturing challenges firsthand, I’ve noticed a growing trend: more dialogue among patients, doctors, and manufacturers. Ongoing transparency, research into alternatives, and clear ingredient labeling offer the best path forward. PEG 2000 plays its part well—but every product should keep up with the times as new knowledge and needs develop.

What are the specifications and purity standards for Polyethylene Glycol 2000 BP EP USP Pharma Grade?

Clarity Behind the Numbers

Polyethylene glycol 2000, often called PEG 2000, doesn’t make headlines, but it quietly powers pharma and biotech jobs every day. When folks see “BP/EP/USP” attached to those four capital letters, they ask about purity, reliability, and what these standards actually mean in practice.

Why USP, BP, and EP Standards Actually Matter

You walk into any working lab or drug manufacturing floor and it hits you right away—one slip-up with a raw ingredient can set off a chain reaction nobody wants. That’s why PEG 2000 carrying pharma-grade status isn’t just about technical labels; it’s earned by consistently showing up clean, safe, and true to expectations. The British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) each lay out specific limits and key quality marks. If you turn to the monographs, PEG 2000 must come across as a white, waxy solid. Slight bitter taste, no odd odor. Water solubility isn’t up for debate; clarity is the rule.

Spec Sheet: Getting Down to Brass Tacks

On the numbers: molecular weight lands between 1900 and 2200 (USP), with each pharmacopoeia backing this up with almost identical boundaries. Ignition residue? BP keeps it below 0.25%. Acid value calls for readings under 0.5 mg KOH/g. The standards chase after low levels of ethylene oxide and dioxane. There’s next to no leeway for toxicity—ethylene glycol and diethylene glycol must fall below 0.25%. Chloride under 0.01%, sulphate under 0.02%. Water content gets checked by the Karl Fischer method, usually aiming for less than 1%.

Heavy metals detection plays out in nearly every protocol. BP says not more than 10 ppm, and any sign of lead or arsenic means trouble. The moment a batch even hints at exceeding those (or microbial limits), pharma companies turn it away. Stability feels almost like a given, but real storage conditions—heat and humidity—test even the best paperwork.

Stepping Away from Paper Toward Safe Practice

When you stand on a shop floor, you see how come purity standards aren’t just numbers on a CoA—they’re a hard requirement so intravenous drugs don’t spark reactions or organ risk later. I’ve watched compounding pharmacists toss a whole drum because its appearance wasn’t right, even before the numbers came back. Even one particle, one hint of contamination, rules out that batch from critical applications.

Tough Talk: Solutions for Upholding Purity

Folks in the field swear by rigorous supplier audits and in-house verification testing. Automated processes can help, but human eyes still catch what bench-top instruments miss. Batch traceability has changed the game, letting teams spot issues right at the sourcing stage. Cross-checking every step with both EP/USP and BP standards covers the common ground. I’ve seen manufacturers push suppliers for extra certificates—microbial tests, solvent residue analysis—and hold them to higher internal targets, especially for injectables.

The takeaway: pharma-grade PEG 2000 isn’t just about ticking boxes. It requires real vigilance, experience on the ground, and a willingness to stop production if anything feels off. The right standards protect patients, build solid reputations, and keep everyone honest, from the lab right out to the patient’s bedside.

Is Polyethylene Glycol 2000 BP EP USP Pharma Grade safe for pharmaceutical and cosmetic applications?

Why PEG 2000 Matters in Modern Formulations

Pharmacists and formulators work with many ingredients, but polyethylene glycol 2000 (PEG 2000) stands out both for its versatility and its long history in medicine and cosmetics. It acts as a base for ointments, softens tablets, prevents creams from separating, and carries active ingredients in some of the products found in medicine cabinets and bathroom drawers. Many people might not even notice PEG on their labels, but professionals in the field pay attention to where their ingredients come from, and how they are processed. That attention to detail keeps treatments safe and reliable.

Safety Track Record and Regulatory Status

PEG 2000 BP EP USP pharma grade meets established standards set by authorities like the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). Pharmaceutical-grade means the product must go through stricter testing for purity and consistency. The FDA approves various grades of polyethylene glycol as an inactive ingredient in tablets, creams, laxatives, and even injectables. Safety studies show PEG is not mutagenic, toxic, or carcinogenic at the levels used in medicines and personal care products. Its long list of medical uses even includes serving as a vehicle for certain vaccines. That history creates trust for manufacturers and users alike.

Allergies, Sensitivity, and Rare Events

Most people tolerate PEGs without any problems, but the rare allergic reaction can happen, as with nearly any substance. In my experience helping people review ingredient lists, true PEG allergies come up far less often than perfume or dye sensitivities, but folks managing complicated allergies sometimes want alternatives. A few high-profile allergic reactions following mRNA COVID-19 vaccines included PEG 2000, raising concerns in clinics and newsrooms. These reactions were extremely rare and mostly affected people with severe allergy histories. For 99% of the population, PEG remains one of the safer ingredients based on modern research and decades of use.

Environmental Aspects and Source Purity

Concerns about contamination occasionally surface, especially in global supply chains. Pure, pharma-grade PEG 2000 passes robust screening processes before heading to production lines in the United States and Europe. Industry standards require checking for impurities like ethylene oxide or 1,4-dioxane—both substances to avoid in finished consumer formulas. Manufacturers hold batch records and perform regular quality audits to prevent lapses. Choosing reputable suppliers and demanding proof of certification should never be overlooked. In some regions, eco-minded buyers ask about biodegradability. PEGs break down slowly compared to plant-derived alternatives, so environmental impacts need consideration if used on a massive scale.

Practical Solutions for Safer and Effective Use

For businesses making pharmaceuticals and personal care products, responsible sourcing makes all the difference. Looking at certificates of analysis and third-party testing builds confidence in the product’s safety. For patients and users, reading ingredient lists and asking manufacturers questions protects those who need special care. The right to know what goes into the products we put onto skin or into our bodies helps everyone make healthier choices. Continued research should guide development of new PEG alternatives for those rare cases when sensitivities matter. In the meantime, PEG 2000 pharma grade remains a reliable and trusted choice backed by science and experience.

How should Polyethylene Glycol 2000 BP EP USP Pharma Grade be stored and handled?

Why Proper Storage Matters

Polyethylene Glycol 2000, known in the pharmaceutical world as PEG 2000 BP EP USP, sits on the shelf in many pharma labs and factories for good reason. I’ve seen what sloppy storage can do, from caking and clumping to product recalls because the raw material picked up moisture or dust. These types of issues waste money and time, but more importantly, they put formulas and patient safety at risk. PEG 2000 often acts as an excipient for tablets, creams, and a host of drug delivery systems. Hidden contaminants could have real downstream impacts.

What Works for Storage

Keep it simple and consistent. PEG 2000 likes dry, stable environments—humidity is the enemy. Even a couple of days in a muggy warehouse can cause it to clump, and that affects the way it pours and mixes. A temperature-controlled room, ideally below 30°C, offers a straightforward fix. I’ve worked in sites using big climate-controlled storage closets; these cut down on variables and make compliance checks easier.

The right container also plays a role. Sealed, food-grade plastic drums or lined steel barrels keep out air, dust, and especially water. If globules appear along the rim, that's a warning—condensation has snuck in. Those small signs can turn into large problems if ignored.

Label every container with clear identifiers. Batch, expiry, and even storage date give you a fighting chance at real traceability. During audits, this record trail lets quality assurance find answers fast.

Handling PEG 2000 Safely

During transfer or weighing, avoid open scoops in open air for long stretches. Use gloves and full-sleeve lab coats. I’ve noticed that exposure to bare skin can cause irritation in some people over time, so personal protection makes sense. If your site handles bulk tonnage, invest in closed transfer systems—these speed up the process and reduce spills.

If a spill happens, don’t let it linger. Polyethylene glycol isn't classified as a hazardous chemical, but it gets slippery—risk goes up fast in production areas with foot traffic. A mop, absorbent pads, and some detergent clean it up, but quick response is the trick. Training everybody, from operators to supervisors, to jump on small incidents stops big ones before they start.

Potential Risks and Good Habits

If PEG 2000 sits too long exposed or heats above its comfort zone, there’s risk of product breakdown. That can mean loss of critical properties—flowability, solubility, and, in missteps I’ve seen, failed batch testing. Building in daily checks for leaks, container integrity, and storage conditions limits these risks.

Documentation also serves as insurance. I remember a case where missing a humidity log meant re-testing an entire day's worth of product. Track and review temperature and humidity readings. This not only satisfies regulatory standards; it gives peace of mind that each lot brings true pharmaceutical grade to the table.

Smart storage and handling begin with respect for the material and a solid routine. Tools, training, and clear policies form the backbone of every quality-driven operation. They also give every team member confidence in safeguarding both materials and end users.

Can Polyethylene Glycol 2000 BP EP USP Pharma Grade be used in food or injectable products?

Spotlight on Pharmaceutical Ingredients

Ask a pharmacist about ingredients in any medicine or injectable, and you’ll quickly learn how carefully every gram gets scrutinized. Polyethylene Glycol 2000, known in hospitals and labs as PEG 2000, pops up in all sorts of pharmaceutical formulas. The “BP,” “EP,” and “USP” tags attached to the name tell you it matches expectations from the British, European, and United States pharmacopoeias. In practical terms, this means it’s produced with a long checklist of purity and safety rules in mind. But right now, there’s curiosity: Can you use PEG 2000 as an ingredient in food or injectable products? Does that pharma-grade label open the door for these uses, or does the story get complicated?

What’s in the PEG 2000 Barrel?

Think of PEG 2000 as a soft, waxy solid. It acts as a stabilizer, helps dissolve molecules that don’t want to blend, and keeps medicines from falling apart before you even swallow them or inject them. In my career, I’ve watched manufacturing teams fuss endlessly over these excipients because even tiny contaminations cause headaches for regulators and, in some cases, public health. Pharma-grade standards—BP, EP, USP—raise the bar. The tests check for heavy metals, ethylene oxide, and common leftover chemicals from manufacturing. That’s critical because the body can react to contaminants with everything from allergies to organ damage.

Inside Food and Injectable Use

PEG 2000 gets a green light for use as an excipient in many medical products. It has history as a base for ointments and as a part of certain vaccines. The Moderna and Pfizer COVID-19 vaccines made PEG a household name, though at lower molecular weights. Injectable use means regulators want to see proven safety—batch after batch without toxins, and evidence that it breaks down or leaves the body without harm.

Using PEG 2000 in food is where people need to hit pause. The food industry sticks to its own food-grade standard for each additive. The U.S. Food and Drug Administration and the European Food Safety Authority look at PEGs differently when they show up in food, compared to medicines. Safety hinges on dose, frequency, and route of exposure. The same polymer that works in tablets or under the skin could cause problems if a factory tossed it into candy or soft drinks, especially without the food-grade paperwork. Certain PEGs, at specific molecular weights and purity, carry FDA approval for use as food additives, but not all grades make the cut. PEG 2000 usually isn’t on the standard food additive lists.

The Right Stuff for Safety

Too often, I’ve seen non-pharma PEGs circulate in supply chains after a product mislabel. Pharma-grade doesn’t equal food-grade. Labs and production lines have different checks for these two worlds. Trace impurities, like ethylene glycol or 1,4-dioxane, spell trouble in food—even in low amounts that would get a pass in a pill coating meant for the stomach. That’s why food makes its own rules.

For anyone formulating injectables, only PEGs matching stringent BP, EP, or USP standards offer the reliability doctors, nurses, and patients expect. Every vial demands certificates of analysis and batch traceability. From my own background, I’ve watched quality control teams flag entire barrels for destruction after a failed test. No shortcuts here—public trust depends on it.

Clear Solutions, Not Shortcuts

Regulators and safety scientists move slowly on these questions for good reason. Each form of PEG, and each grade, needs its own safety testing depending on the use—be it swallowed, injected, or applied to skin.

For companies, the answer is simple: choose PEG 2000 only for the uses backed by its specific grade approval. In food, stick with additives certified as food grade—and nothing less. No one wants to learn about safety lapses the hard way. Public health and trust always matter more than cutting corners with the wrong grade.

Polyethylene Glycol 2000 BP EP USP Pharma Grade
Names
Preferred IUPAC name poly(oxyethylene)
Other names Carbowax 2000
PEG-2000
Macrogol 2000
Polyox WSR N-10
Polyethylene oxide 2000
Pronunciation /ˌpɒl.iˈɛθ.ɪˌliːn ˈɡlaɪ.kɒl ˈtuː ˈθaʊ.zənd biː piː iː piː ˈjuː ˈɛs ˈpiː ˈfɑː.mə ɡreɪd/
Identifiers
CAS Number 25322-68-3
Beilstein Reference 5832
ChEBI CHEBI:61807
ChEMBL CHEMBL1201474
ChemSpider 32583
DrugBank DB09273
ECHA InfoCard 03c4c76c-c7c5-4af2-bb7b-81e6b6c64c46
EC Number 500-038-2
Gmelin Reference Gmelin Reference: 82892
KEGG C02336
MeSH D020857
PubChem CID 84956
RTECS number MU8400000
UNII 3WJQ0SDW1A
UN number UN3082
CompTox Dashboard (EPA) DTXSID0051872
Properties
Chemical formula C2nH4n+2On+1
Molar mass 2000 g/mol
Appearance White solid flakes or powder
Odor Odorless
Density 1.15 g/cm³
Solubility in water Soluble in water
log P -4.8
Vapor pressure < 0.01 hPa at 20°C
Acidity (pKa) Approximately 15.
Basicity (pKb) 7.7
Refractive index (nD) 1.460 - 1.465
Viscosity Viscosity (cP at 25°C): 400-500
Dipole moment 1.15 D
Thermochemistry
Std molar entropy (S⦵298) 253.7 J·mol⁻¹·K⁻¹
Std enthalpy of formation (ΔfH⦵298) -578.6 kJ/mol
Std enthalpy of combustion (ΔcH⦵298) -25.2 kJ/g
Pharmacology
ATC code A06AD15
Hazards
Main hazards May cause eye irritation. May cause skin irritation. May cause respiratory tract irritation.
GHS labelling GHS05, GHS07
Pictograms GHS07
Hazard statements No hazard statements.
Precautionary statements Keep container tightly closed. Store in a cool, dry place. Use personal protective equipment as required. Avoid contact with eyes, skin, and clothing. In case of inadequate ventilation wear respiratory protection. Wash hands thoroughly after handling.
NFPA 704 (fire diamond) 1-0-0
Flash point > 238°C
Autoignition temperature > 350°C
Lethal dose or concentration LD50 (oral, rat): > 20,000 mg/kg
LD50 (median dose) LD50 (oral, rat): > 20,000 mg/kg
NIOSH NotListed
PEL (Permissible) Not established
REL (Recommended) 10 mg/m³
IDLH (Immediate danger) No IDLH established.
Related compounds
Related compounds Polyethylene Glycol 400
Polyethylene Glycol 600
Polyethylene Glycol 1500
Polyethylene Glycol 3350
Polyethylene Glycol 4000
Polyethylene Glycol 6000
Polyethylene Glycol 8000