Propylene Glycol USP/EP Grade

    • Product Name: Propylene Glycol USP/EP Grade
    • Chemical Name (IUPAC): propane-1,2-diol
    • CAS No.: 57-55-6
    • Chemical Formula: C3H8O2
    • Form/Physical State: Liquid
    • Factroy Site: Yudu County, Ganzhou, Jiangxi, China
    • Price Inquiry: sales3@ascent-chem.com
    • Manufacturer: Ascent Group Co., Ltd
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    Specifications

    HS Code

    706103

    Chemical Name Propylene Glycol
    Synonyms 1,2-Propanediol
    Molecular Formula C3H8O2
    Molar Mass 76.09 g/mol
    Appearance Colorless, odorless, viscous liquid
    Purity ≥ 99.5% (USP/EP Grade)
    Boiling Point 188.2 °C
    Melting Point -59 °C
    Density 1.036 g/cm³ at 20°C
    Solubility Miscible with water, acetone, chloroform
    Ph 6.0–8.0 (50% aqueous solution)
    Cas Number 57-55-6
    Refractive Index 1.4318 at 20°C

    As an accredited Propylene Glycol USP/EP Grade factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing Propylene Glycol USP/EP Grade is packaged in a 25-liter high-density polyethylene drum, securely sealed, and clearly labeled with product information.
    Container Loading (20′ FCL) Container Loading (20′ FCL) for Propylene Glycol USP/EP Grade: 80 drums x 215 kg each, totaling 17.2 metric tons net.
    Shipping Propylene Glycol USP/EP Grade is shipped in sealed, food-grade containers such as 215 kg drums, 1,000 kg IBC totes, or bulk tankers. Packaging meets regulatory safety standards, ensuring product integrity and protection from contamination, moisture, and sunlight. All containers are clearly labeled and accompanied by Safety Data Sheets (SDS).
    Storage Propylene Glycol USP/EP Grade should be stored in tightly closed containers, in a cool, dry, and well-ventilated area, away from direct sunlight, heat sources, and oxidizing materials. Store at temperatures between 15°C and 30°C. Ensure containers are labeled properly and kept off the floor to avoid contamination. Follow all safety regulations and guidelines for chemical storage.
    Shelf Life Propylene Glycol USP/EP Grade typically has a shelf life of 2 years when stored in tightly closed containers under recommended conditions.
    Application of Propylene Glycol USP/EP Grade

    Purity 99.8%: Propylene Glycol USP/EP Grade with a purity of 99.8% is used in injectable pharmaceuticals, where it ensures consistent solubility and safety for parenteral formulations.

    Viscosity 58 mPa·s: Propylene Glycol USP/EP Grade with a viscosity of 58 mPa·s is used in oral liquid medicines, where it provides optimal mouthfeel and uniform dispersion of active ingredients.

    Microbial Limit <10 cfu/g: Propylene Glycol USP/EP Grade with a microbial limit of less than 10 cfu/g is used in topical dermatological preparations, where it guarantees microbiological safety and product integrity.

    Moisture Content <0.2%: Propylene Glycol USP/EP Grade with moisture content below 0.2% is used in food flavoring concentrates, where it assures stability and prevents ingredient degradation.

    Stability Temperature up to 150°C: Propylene Glycol USP/EP Grade stable up to 150°C is used in heat transfer fluids for food processing, where it enables efficient heat exchange without decomposition.

    Molecular Weight 76.09 g/mol: Propylene Glycol USP/EP Grade with a molecular weight of 76.09 g/mol is used in e-liquid formulations, where it delivers precise vaporization and controlled inhalation profiles.

    Acidity (as acetic acid) ≤ 0.005%: Propylene Glycol USP/EP Grade with acidity not exceeding 0.005% is used in ophthalmic solutions, where it minimizes irritation and preserves eye comfort.

    Heavy Metals Content <0.5 ppm: Propylene Glycol USP/EP Grade with heavy metals content below 0.5 ppm is used in infant nutritional supplements, where it assures product purity and consumer safety.

    Melting Point -59°C: Propylene Glycol USP/EP Grade with a melting point of -59°C is used in antifreeze and de-icing formulations for pharmaceutical transport, where it maintains flowability at subzero temperatures.

    Peroxide Value <0.5 meq/kg: Propylene Glycol USP/EP Grade with a peroxide value under 0.5 meq/kg is used in vitamin and nutraceutical syrups, where it protects against oxidative degradation of sensitive components.

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    Certification & Compliance
    More Introduction

    Propylene Glycol USP/EP Grade: From Our Production Line to Your Application

    Understanding Propylene Glycol USP/EP Grade Through Our Manufacturing Lens

    We have spent years refining our approach to high-purity propylene glycol, and the result speaks for itself in the consistent quality of our USP/EP grade output. Every batch rolling out of our facility demonstrates our technical commitment: colorless, practically odorless, and tested for maximum purity. Our model for this product always aligns with the standards of the United States Pharmacopeia and the European Pharmacopoeia. That means the material passes each round of impurity testing—especially chasing down traces of diethylene glycol, heavy metals, and water content—because consumer safety runs through every step of production.

    Setting up our process, we decided against cutting corners. Distillation and purification sequences run on tight tolerances because the smallest deviation can shift compliance or performance. Trace contaminants stay under control by running regular calibrations and using refined input streams. Our technical team revises analytical methods often, always checking the latest regulatory updates. The end product consistently exhibits minimum levels of water and trace substances, supporting sensitive end-uses such as food flavors and pharmaceuticals.

    Physical and Chemical Properties That Matter for Performance

    Over many years handling raw materials and running analytic tests, experience tells us that details such as viscosity, charring point, and water miscibility shape the product’s value once it leaves our plant. Our USP/EP grade propylene glycol lands predictably in terms of density and refractive index, making downstream formulation math less stressful. Customers mixing flavors or medicinal syrups can add our propylene glycol with predictable behavior—no cloudiness, no flavor shift, even with repeated exposure to air.

    This tight control on qualities translates directly to handling and storage. As longtime manufacturers, we prefer quality that holds under typical warehouse conditions—no surprises from uneven storage temperatures. Clean, dry drums lined for low reactivity preserve the glycol’s low color and clarity, while inert gas blanketing stops oxidation for suppliers holding stock longer.

    Meeting USP/EP Requirements: Why Testing and Recordkeeping Outperform Marketing Claims

    On the plant floor, our quality team works off validated protocols—there is no “good enough” guesswork when the market expects full USP and EP compliance. We validate on-site instrumentation against certified standards, not just for formality, but because a single drift in water content or organic impurity can cause recall-level fluctuations. The certificate of analysis coming with every shipment shows our full compliance, backed by batch records and traceability. We know audit time means digging through months of data; after thousands of internal and external audits, the proof remains in the numbers, not the marketing.

    Clients in regulated sectors often ask for random batch samples or stricter impurity thresholds; our plant’s line managers never object, because each shift operates under documented GMP and controlled environmental conditions. Real experience tells us that the tighter the system, the lower the risk when the product lands in food, drinks, or medicine. For every customer who inspects our process, we stand ready to open our SOPs—down to the parts-per-million.

    Comparing USP/EP Grade to Other Grades: Lessons from Technical Experience

    Manufacturing various grades of propylene glycol for decades sheds light on the misconceptions about “purity” and “quality.” Our industrial/technical grade has different impurity allowances and serves industrial coolants, resins, and antifreeze. Crafting USP/EP grade means re-thinking raw material selection, tightening process controls, and raising batch documentation to a level expected in pharma or food production. Small plants often try to cross-sell lower-grade stock for regulated applications; we have seen buyers face compliance issues and costly recalls from shortcuts like that.

    Pharmaceutical and food formulators use USP/EP grade glycol to cut liability and guarantee that no unsafe byproducts travel downstream. Trace levels of ethylene glycol, chlorides, or heavy metals—barely relevant for coolants—become deal-breakers in mouthwash, injectable drugs, or consumer beverages. Evidence-based batch testing costs time and money, but years of customer feedback and regulatory site visits taught us shortcuts do not pay off in these uses.

    From Tank Farm to Finished Drum: Operational Rigor

    Our manufacturing floor runs on checks, not assumptions. We draw feedstock from ISO-certified suppliers. Operators keep all stages—hydration reactors, distillation columns, filtration systems—under monitored temperature, vacuum, and pressure. Human error drops when equipment runs full automation, but experienced eyes handle the critical handoffs: first-draw product gets tested, filtered, and sampled. Every shift rotation includes documented checks on seals, gaskets, and cleaning in place, not just because regulations say so, but because a missed cleaning can compromise an entire day’s run.

    Working on-site, our supervisors have seen how minor maintenance matters. Glycol exposed to residual oils or acids in a pipe will drop the batch below pharma spec. Our tanks, lines, and reactors stay passivated and inspected to keep cross-contamination off the table. We do not recycle off-spec glycol into flagship batches; that material moves to technical-grade sales or internal non-regulated uses. Years facing root cause investigations convinced us: keeping the QA process tight saves trouble.

    Health and Safety Factors: Beyond the Data

    We field tough questions about glycol’s safety for ingestion and contact every year. The USP and EP standards grew out of public health data. Through proper production controls, our grade leaves behind impurities linked to adverse reactions. For ingestible and topical products, buyers want the assurance that every barrel they receive falls within the tightest limits on contaminants and byproducts.

    In the lab, our team confirms propylene glycol’s low toxicity by ensuring extreme purity, reducing allergen potential. No product clears production without a battery of tests—ethylene glycol levels, residual solvents, and microbiological controls. We recall past incidents industry-wide where shortcuts or mislabeled grades led to recalls or poisonings; those risks fuel our retention of skilled chemists and routine retraining for every technician on the line.

    The Real-World Uses: Pharmaceutical, Food, and Cosmetic Practitioners

    Experience tells us demand spikes when regulatory climates tighten. Formulators turn to our USP/EP glycol for cough syrups, soft drink concentrates, vape liquids, skin creams, oral care, and more. Regulatory teams scour ingredient decks for grades that meet food and drug registration—clients working with us cite these records as reasons to stay with a manufacturing partner, not chase the lowest price on the open market.

    Large pharma houses audit our plants. Many require ongoing supply chain transparency, including re-audits with changes in personnel or equipment. Small-batch craft manufacturers—artisan e-liquids and flavors—prefer our glycol’s neutral taste, consistent viscosity, and reliable solubility. Over time, repeat business from both sectors tells us our hands-on approach and willingness to accommodate customer-specific documentation keeps our product in demand.

    Storage and Transportation: Lessons from Practice

    Drums and totes leave our yard sealed and labeled, straight from temperature-controlled storage. We avoid prolonged open-air transfer or excessive pumping to reduce the risk of moisture uptake or airborne dirt. Our logistics crew recognizes how even a single punctured seal can wipe out a clean batch’s integrity; the stories of contaminated glycol entering food chains stay with us, sharpening our approach to packaging.

    Many of our customers only realize the value of secure containers after a bad batch from another supplier. Eventually, even experienced handlers learn that well-designed transport protocols save work and liability down the road. Our crews re-inspect each seal and label before loading, following documented chain-of-custody until receipt. This lowers the chance of product disputes, lost paperwork, or accidental exposure during unloading.

    Why Manufacturing Practice Cuts Down on Unwelcome Surprises

    On-the-ground experience shows that operational rigor pays dividends during unexpected audits or national recalls. Our team trains yearly on evolving regulatory requirements; we implement new analytical tests for nitrosamines or potential food allergens faster than most. Changes in compendial monographs mean new test protocols—our QC staff works with published data, not broad assumptions, to update testing routines. We keep retained samples for extended periods, not as a paper exercise, but because regulatory investigators want proof of what you shipped years ago.

    History in this sector tells us that buyers need a responsive partner, especially when regulatory bodies modify limits or documentation requirements. We treat every question or request for substantiation as a normal part of doing business, not a nuisance. Our technical sales and regulatory teams collaborate directly with plant leadership so that responses come from hands with real product knowledge, not just a script.

    Sustainability in Sourcing and Manufacturing: Our Approach

    The conversation around propylene glycol’s origin increasingly includes sustainability. We source feedstocks from suppliers who track environmental impacts, and every major process uses closed-loop water cooling and emissions scrubbing for regulatory and community health reasons. Spills or leaks are managed at the incident level—training and drills reinforce the behaviors expected in a specialty chemicals operation. Over time our energy team upgraded reactors and distillation for higher heat efficiency, reducing fuel demand and supporting lighter site-wide carbon reporting.

    Catalyst recovery and solvent use stay tightly managed—unrecovered materials do not exit our plant untreated. Years of dialogue with local environmental authorities taught us that compliance is ongoing and requires investment, not just reporting. We look ahead at future requirements on manufacturing emissions and raw material traceability, investing now to stay ahead of the curve for our clients whose brands depend on sound environmental stewardship claims.

    Common Challenges and How We Address Them

    Any manufacturer dealing in high-purity materials faces certain recurring obstacles. Analytical drift, batch-to-batch variation, and fluctuating raw material purity can challenge even the most seasoned chemists. Our plant managers, backed by years on the floor, review trend data from critical test stations—addressing detection limits, re-calibrating sensors, and scheduling preventive maintenance for core equipment. Those routine steps seem minor until a customer lot gets flagged, but history tells us daily discipline prevents major disruptions.

    Customers switching from lower grade glycols often face unexpected formulation changes—cloudiness, off-flavors, or viscosity drift. Our technical support team provides practical formulating tips, drawn from direct experience with cross-industry product development. Interruptions in global supply chains remind us there is no one-size-fits-all solution; we support clients with adjusted shipping, documentation, and occasional rush production, all while retaining product quality. Over time, a reputation for reliability and openness reduces noise and keeps business relationships on solid footing.

    End-User Responsibilities: What Our Clients Should Remember

    Years working directly with finished producers taught us that even the purest glycol hinges on good downstream practice. Clients benefit most when they use proper storage, manufacturing hygiene, and documentation. Temperature, exposure to air, and material compatibility play critical roles in final product quality. We advise customers candidly: mixing different supplier grades or reselling drum leftovers can trigger unexpected compliance failures.

    Auditors increasingly focus on traceability. We help clients by maintaining rigorous batch records and supplying documentation that matches delivery lots exactly. We have seen many customers protect themselves by running quick verification testing before each batch use. This habit, aided by our certificates and data sheets, gives final assurance before a major production campaign.

    Our Commitment to Continuous Improvement

    Constructing a facility that consistently delivers on USP/EP standards is an ongoing project. Every year, we evaluate our practices against regulatory changes and customer feedback. Staff training covers new analytical techniques, process safety, and evolving supply chain traceability demands. Collaboration between plant operations, quality control, and regulatory affairs drives ongoing upgrades to methods and documentation.

    Our open dialogue with pharmaceutical, food, and personal care customers keeps us alert to new challenges, from shifts in compendial purity limits to new environmental emission guidelines. Every time a new question or requirement arises, our team tests, revises, and implements to improve workflow and product safety. This rhythm—founded in experienced practice—ensures the USP/EP grade glycol shipped from our plant reflects industry leadership, not just compliance paperwork. Customer trust follows continuous, transparent improvement as much as strict batch control.

    Concluding Insights from the Manufacturer’s Perspective

    Years in this business give clarity on what sets USP/EP propylene glycol apart. Our experience tells us quality comes from discipline, testing, and patient investment, not just from clever marketing or price competition. Buyers in tightly regulated sectors look for real transparency and reliability. By keeping our processes open to inspection and our documentation tight, we help clients achieve their safety, quality, and regulatory goals—batch after batch.

    Collaborating with formulation teams, we solve problems when they arise: from adjusting to regulatory update fallout, to answering tough questions during audits. Our batch records, retained samples, calibration logs, and technical staff interviews have all withstood regulatory scrutiny—not thanks to luck, but because we treat each step with the seriousness demanded by end-users and authorities. This combination of experience, rigor, and open communication defines our contribution to safe, stable, and high-quality propylene glycol for any application requiring USP/EP compliance.