Contact Us
Chengguan District, Lanzhou, Gansu, China
© 2025 Jeifer Pharmaceutical, All Right
Reserved.
Trehalose Dihydrate BP EP USP Pharma Grade stands out as a disaccharide made up of two glucose molecules. Known for its strong water retention ability, this compound appears in crystalline, powder, and sometimes pearl forms, allowing for straightforward application in pharmaceutical manufacturing and biopharma processes. The character of this substance traces back to its roots in nature; trehalose actually occurs in baker's yeast, certain fungi, and plants such as sunflower seeds. Its molecular formula is C12H22O11·2H2O, and its structure—essentially two glucose rings tied with an α,α-1,1-glucosidic bond—gives it a high level of chemical stability under both heat and acidic conditions. People who work with trehalose often appreciate its high purity and batch consistency, especially in the pharmaceutical sector where impurities can affect drugs’ safety and effectiveness.
Trehalose Dihydrate adopts a distinctive crystalline structure that keeps moisture out better than many other sugars. In its purest forms, the material comes as either a white crystalline powder or clear colorless crystals. This dihydrate version includes two water molecules, influencing its stability and melting point. Solid trehalose maintains a density around 1.58 g/cm³, present as solid flakes, fine crystals, or powder—never as a hazardous dust if processed with care. Due to its non-hygroscopic nature, trehalose powders don't cake up as easily as some alternatives stored in humid conditions. Chemically, trehalose holds together in a single, firm crystal lattice, which prevents breakdown by many enzymes and keeps it stable under standard storage or transport conditions. In water, trehalose creates clear solutions, resulting from its high solubility—almost 68g per 100ml at room temperature—making it practical for both liquid and solid pharmaceutical applications.
Pharmaceutical grade trehalose follows strict guidelines, including BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) standards for ingredient safety and purity. These authorities require assays of ≥98.0%, with low moisture content and nearly zero contaminants like lead or arsenic. Bulk shipments of trehalose can be recognized by the HS Code 1702.90, reserved for other sugars chemically pure. Each batch ships with certificates of analysis, showing detailed breakdowns of specific gravity, melting point (around 97°C for the dihydrate), and solubility measures in both water and ethanol. Pharmacopeial tests confirm the compound lacks harmful residue, microbial growth, or volatile impurities that could interfere with drug development.
The trehalose molecule measures up as C12H22O11·2H2O, carrying a molecular weight of about 378.33 g/mol when accounting for the two water molecules in the dihydrate. Its tightly bonded structure resists acid-catalyzed hydrolysis—a trait not all disaccharides share. Measuring density, trehalose holds steady at approximately 1.58 g/cm³ as a solid crystal, but mixtures and solutions can show slightly different densities depending on volume, concentration, and temperature. Understanding specific gravity becomes vital during quality checks for pharmaceuticals, where dosing precision can determine clinical trial success or failure.
Manufacturers offer trehalose dihydrate in a variety of forms tailored for different production needs. Fine powder provides a high surface area, dissolving rapidly into water or injectable solutions. Flake forms, on the other hand, sometimes serve special compounding needs, breaking down under mechanical stress. Pearls, which look much like tiny round beads, suit facilities with automated dispensing since they pour cleanly and don’t cling to surfaces. Ready-made liquids and aqueous solutions, highly valued in biological or clinical settings, bypass the need for in-house dissolution and sterile processing. Crystals—typified by glossy, almost glassy appearance—find use in processes where a slow and steady release of sugar helps protect biological molecules during freezing or drying.
Industrial trehalose production usually starts with enzymatic conversion of starch from plant raw materials like corn or cassava. After extraction, the product undergoes stiff refining and crystallization to clear away any plant matter, proteins, or residual enzymes. Trehalose dihydrate plays a key role as a raw material in everything from freeze-dried vaccines to protein-based drugs and even specialized creams. Its shelf-stable properties, coupled with an ability to shield cells from dehydration, extend the storage life of sensitive active ingredients in medicines and biologics. Beyond pharmaceuticals, food technologists look to trehalose as both a sugar replacer and an ingredient capable of retaining texture, especially in frozen foods or baked goods meant to stay fresh longer.
Pharma grade trehalose dihydrate checks the boxes for safety in pharmaceutical, food, and cosmetic use. Safety evaluations report it as non-toxic, non-mutagenic, and non-carcinogenic, with no hazardous residue under routine industrial conditions. Workplace safety data sheets usually list trehalose as a non-hazardous chemical, labeling it with minimal risk for respiratory or skin contact. If handled without care, any sugar dust—trehalose included—can pose a minor nuisance by irritating the airways, but it lacks the flammability of starch and doesn’t create harmful breakdown products when heated. Emergency protocols highlight the need for dust control and standard hygiene, but medical practitioners rarely encounter allergic reactions or safety issues linked to pure trehalose. Regulatory approvals between North America, Europe, and Asia agree on its low-risk profile, underlining its place as a dependable chemical in large-scale drug and food production.
Years spent in labs with freeze-dried biologics, or setting up QA protocols for bulk excipient shipments, have shown the quiet importance of reliable trehalose dihydrate. Failures in freezing and thawing operations in biologics stem from poor excipient selection, and trehalose’s resilience against temperature swings offers insurance against expensive losses. Pharmaceutical companies invested in trehalose not just for quality assurance, but for its scientific track record. Some published studies confirm the role of trehalose in extending cell viability, protecting proteins, and aiding in lyophilization. Real-world use in vaccine manufacturing or eye drop compounding brings out the need for well-documented, traceable, and high-purity sugar sources—people need confidence that every gram supports human health and safety, free of risky contaminants.
To address modern manufacturing demands, producers have started ramping up quality checks on water, raw ingredients, and every step of the refinement chain. Batch-to-batch consistency, a sticking point for many other sugars, gets handled better with full analytical traceability—good suppliers share data on density, crystal habit, microbial load, and precise chemical profile. Investment in automated packaging and climate-controlled logistics helps maintain both the dihydrate structure and shipping safety. On the regulatory front, ongoing dialogue between international pharmacopoeias and food safety authorities can smooth the way for future product innovations. If there’s a challenge, it comes down to strengthening transparency for buyers, regulators, and patients. Full digital documentation, QR codes tracing back raw sources, or online batch reports—these tools can close the knowledge gap across labs, warehouses, and clinics, allowing more people to benefit from proven, clean investments in trehalose dihydrate.
Chengguan District, Lanzhou, Gansu, China
