Contact Us
Chengguan District, Lanzhou, Gansu, China
© 2025 Jeifer Pharmaceutical, All Right
Reserved.
Polyethylene Glycol Monoglyceride BP EP USP Pharma Grade stands out in pharmaceutical applications for its versatile nature, reliable quality, and well-established performance. This compound builds its backbone from ethylene oxide and glycerol, offering a balance of hydrophilic and lipophilic properties. Its presence in pharma manufacturing, food additives, cosmetics, and specialty chemicals traces back to its ability to act as an emulsifier, solubilizer, and stabilizer. For pharmaceutical users demanding trust in raw materials, this grade follows standards set by British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP), ensuring high consistency, purity, and traceability.
Polyethylene Glycol Monoglyceride often appears as white to off-white flakes, solid blocks, fine powder, crystalline granules, or even pearl-shaped pellets, depending on its specific manufacturing run and storage conditions. Its physical form offers convenience during handling and mixing, staying stable at room temperature and exhibiting low volatility. In some specialized batches, liquid and semi-solid forms can be sourced—these adapt to different compounding requirements. Density ranges between 1.10 to 1.25 g/cm³, and the material stays odorless, which preserves sensory quality in sensitive pharma use cases. Its molecular formula, typically CnH2n+2O3 for a single average chain, varies with the length of the ethylene glycol segment. Average molecular weights can shift widely (typically from 200 to over 4000 Da), driving differences in melting point, viscosity, and solubility. In solid form, melting points fall within 35°C to 60°C. These physical traits directly affect how this ingredient dissolves in water and alcohol, which matters greatly during tablet or cream production.
Looking closer at its chemistry, Polyethylene Glycol Monoglyceride features a glycerol head attached to a polyethylene glycol tail, creating a block-ether structure. This results in an amphiphilic molecule—one side attracts water, while the other links with oils—making it perfect as an emulsifier in both hydrophilic and lipophilic mixtures. This unique structure supports stable dispersion of active ingredients, helping tablets, suspensions, creams, or liquids keep their consistency and potency over time. In practical work, this means less need for stabilizing agents and more predictable formulation outcomes, especially for drugs sensitive to moisture or pH swings.
The BP, EP, and USP standards guarantee strict limits on impurities, moisture content, heavy metals, and microbial contamination. Most pharma-grade Polyethylene Glycol Monoglyceride exceeds 98% purity. Measurement involves advanced analytic techniques like HPLC, GC, and FTIR, each providing traceability and batch-level identity. Water content usually stays below 1.0%, avoiding unwanted hydrolysis or degradation during storage. Hazardous impurities—such as residual catalysts, ethylene oxide, diethylene glycol, or aldehydes—almost always fall below toxicological thresholds to protect users. Specification tables detail viscosity range in mPa.s, average chain length, acid and saponification values, peroxide limits, and lead content, supporting quality control during batch release. These parameters also shape the product’s performance in direct compression, wet granulation, and coating processes.
For customs, tariffs, and shipping documentation, Polyethylene Glycol Monoglyceride falls into HS Code 3402.13, the tariff entry for non-ionic organic surface-active agents. Logistic workers and customs brokers rely on this code for all cross-border movement, taxation, and regulatory review. Its listing across pharmacopoeias demonstrates compliance with international regulations for pharmaceutical ingredients, including global safety, traceability, registered source, and documentation requirements for drug master files (DMFs). This eliminates unnecessary regulatory barriers when sourcing for multinational production, whether handling finished dose manufacturing or contract development.
From long experience in plant and cleanroom environments, workplace safety always rides on up-to-date material safety data sheets (MSDS). Polyethylene Glycol Monoglyceride proves generally safe, non-toxic, non-flammable, and non-irritating under normal conditions. But as with any industrial chemical, bulk powder or fine flakes risk minor mechanical irritation to eyes or upper airways. Protective gloves, dust masks, and goggles reduce these workplace hazards. Polyethylene glycol derivatives rarely trigger major acute toxicity or allergic responses in the short term, but repeated or excessive exposure—especially in respiratory form—should still be minimized. Emergency handling calls for good ventilation and spill control with standard absorbent materials. For environmental safety, Polyethylene Glycol Monoglyceride degrades gradually in soil and water, presenting low bioaccumulation risk, yet all facilities maintain appropriate drainage management and waste separation under local regulations. Every batch includes clear labeling of lot number, expiry date, manufacturer, and handling precautions, enabling safe handing from warehouse to dispenser counter.
Pharmaceuticals count on Polyethylene Glycol Monoglyceride for its predictable solubilizing and emulsifying performance in everything from tablets and capsules to ointments and suspensions. Manufacturers can choose from powder for blending with actives, solid flakes for melt-casting, or liquid and semi-solid for creams. In direct compression, its flowability and compatibility boost uniform drug distribution. Ointments rely on its amphiphilic properties to balance oil and water, delivering active ingredients evenly and prolonging shelf life. Dermal, oral, and even some ophthalmic drugs call on this grade for its absence of irritating or sensitizing residues. Food and cosmetics benefit from its similar solubility and stabilizing features, though always using food-grade or pharma-grade for maximum consumer safety. In lab and pilot plant, Polyethylene Glycol Monoglyceride powder disperses easily into aqueous or oil phases, cutting down mixing times and energy costs.
Reliable Polyethylene Glycol Monoglyceride production starts with ethylene oxide and high-purity glycerol. Both must meet stringent purity standards to prevent harmful byproducts or off-flavors in sensitive pharma end products. Large-scale manufacturing usually follows strict GMP, ISO, and HACCP quality programs, ensuring traceability from raw material receipt through finished lot release. Sourcing teams scrutinize supplier credentials, chain-of-custody documentation, COA batch data, and even routine plant audits, forging trust in every shipment. Technicians run frequent sampling for identity, purity, heavy metal, and microbiological testing at every stage—never leaving anything to chance.
Despite its robust safety and performance record, users sometimes face challenges sourcing genuine pharma-grade Polyethylene Glycol Monoglyceride, especially in regions with fragmented distribution. Counterfeiting, substitution with low-grade alternatives, and inadequate documentation can threaten batch quality and patient safety. Addressing these risks takes a multifaceted approach: building long-term relationships with established suppliers; performing routine incoming raw material testing; investing in laboratory capacity for advanced analytics; and implementing post-market surveillance of final product stability. Insisting on full regulatory traceability, batch-specific COAs, and transparent documentation guards against compliance failures and enables swift recalls if ever needed.
Polyethylene Glycol Monoglyceride BP EP USP Pharma Grade brings well-documented safety, reliable performance, and robust quality control to complex pharmaceutical supply chains. Knowing its deep technical characteristics—physical form, density, chemical structure, regulatory status, and raw material sourcing—lets buyers and formulators build trust, reduce risks, and deliver quality medicines with confidence. Sound sourcing practices and up-to-date laboratory controls ensure safety and compliance from factory floor to finished package, upholding the high standards patients and health practitioners expect.
Chengguan District, Lanzhou, Gansu, China
