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Glyceryl Mono- And Distearate stands out in the world of pharmaceutical ingredients for both its versatility and its safety profile. This material often appears as a white or almost white solid, sometimes broken down into tiny flakes, fine powder, small pearls, or even chunky crystalline forms. Each of these forms comes from careful manufacturing, using raw materials like stearic acid sourced from natural fats and refined glycerol. Pharmaceutical and food companies select this ingredient because of the well-established data around its molecular structure and properties, which drive its physical behaviors in products you use every day. Chemical manufacturers use a method called esterification, blending the fatty acids and glycerol together under controlled conditions, and the result is a compound that’s stable, solid at room temperature, neutral in taste, and odorless.
Glyceryl Mono- And Distearate features a molecular formula of C21H42O4, breaking down to carbon, hydrogen, and oxygen. The molecule itself combines both monostearate and distearate forms, bringing together monoesters and diesters of glycerol and stearic acid. This structure means the substance works as both an emulsifying agent and a thickener in many pharma formulations. Its molecular weight lands around 358.56 g/mol for the monostearate component and roughly 615 g/mol for the distearate, reflecting variations in how the ester bonds form. It registers under the Harmonized System Code (HS Code) 291570, which phama companies use on customs forms and shipping documents for chemical substances. Chemical industry databases often list the product as safe to handle for experienced staff, provided they follow established safety procedures for powders and fats.
Manufacturers tend to specify Glyceryl Mono- And Distearate BP EP USP by purity, melting point, appearance, acid value, iodine value, heavy metal content, and sometimes solubility or particle size. The melting point sits between 55 and 65 degrees Celsius, depending on the ratio of mono- to distearate. The density runs about 1.03 kg/liter, showing the solid mass occupies more space compared to many common liquids used in processing. You will not see strong odors, and the color should stay white or just slightly off-white, as any yellowish tinge might signal impurities. Suspended in water, Glyceryl Mono- And Distearate forms milky dispersions or solutions, but it dissolves with more ease in hot oils or alcohol. Factory settings usually produce the material as fine flakes, pearls, or powder, so that formulators can dose and handle it without special equipment.
This substance helps with the consistency and stability of creams, tablets, and some injectable solutions. It gives tablets a smoother surface, so they don’t stick during compression. Glyceryl Mono- And Distearate can thicken ointments or creams, make them flow and spread more easily, and create stable mixtures where oil and water blend together. These effects come from the amphiphilic nature of the chemical structure, bearing both water-loving (hydrophilic) and oil-loving (lipophilic) sections. Tablets and capsules benefit from the lubricating and anti-adherent properties. Formulators rely on strict pharmaceutical grades, meeting British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) requirements, to guarantee safety and set impurity limits well below the thresholds for harmful substances.
Pharmaceutical and food manufacturers receive Glyceryl Mono- And Distearate in different shapes, each serving a practical purpose. Flakes offer easy melting and controlled dosing in mixing tanks. Powders spread well through dry blends and premixes, especially for tableting processes. Pearls and granules resist caking in warm or humid climates, staying free-flowing inside storage drums or big bags. Each form stays solid at room temperature, avoiding spills or leaks and making it easier for workers to clean up after batches. Some suppliers provide a liquid blend for easier pumping, combining Glyceryl Mono- And Distearate with other compatible esters or diluents. Regardless of the form, each lot comes with certificates of analysis, confirming it meets the critical specifications for medicinal products.
Most sites categorize Glyceryl Mono- And Distearate as a low-hazard chemical, safe for raw material storage with standard precautions. It will not catch fire easily, spill toxic fumes, or corrode storage tanks or packaging. Regulatory bodies require safe labeling, so bags and drums list the chemical name and warnings in line with GHS and REACH guidance. Safety Data Sheets show that workers should handle the powder with dust masks or respirators, as any small particle could cause mechanical irritation if inhaled in high concentrations. Storage should stay dry and cool, preventing clumping in drums and preserving the physical properties required for pharmaceutical processing. In case of a spill, sweeping up the solid and disposing of it as non-hazardous waste usually meets local safety needs. Most industry users value its track record: it does not contain known allergens, mutagens, or irritants when pharma-grade manufacturing practices are applied.
Pharmaceutical industries look for Glyceryl Mono- And Distearate BP EP USP for some key reasons: its ability to function as an emulsifier, stabilizer, and texture agent. Ingredient choices often revolve around efficiency and predictability, and this substance meets those needs in oral, topical, and even some parenteral medicines. Skin creams get a velvety feel, without greasiness, because this compound stops oily ingredients from separating out. Tablet manufacturers count on it to keep their machines running evenly, producing smooth, break-resistant pills that dissolve reliably when used. Laboratories report steady batch-to-batch performance, as long as the powder or flakes come from accredited, GMP-certified plants. Quality assurance labs rely on established analytical tests to prevent any harmful variation in the molecular structure or impurity levels.
Batch processing large quantities of a solid emulsifier introduces challenges, especially in modern pharmaceutical plants. Flakes might clump if stored too humid, and powders may present explosion risks if dust builds up around electrical equipment. Pearl and granular forms ease metering but sometimes slow melting, requiring precise heat controls in batch tanks. Training staff to understand correct storage and handling, including routine checks for moisture and purity, becomes crucial. To maintain product quality and minimize waste, suppliers and formulation chemists turn to vacuum-sealed packaging or nitrogen blankets for bulk quantities.
Raw material choice has a direct impact on patient safety and the success of finished drugs or creams. Only trusted, pharma-grade Glyceryl Mono- And Distearate from traceable plant sources meets the tight needs of world markets. Many manufacturers require full certificates showing the compound’s traceability, purity, and compliance with international standards. They avoid generic or technical-market grades, which may violate regulatory rules or introduce undetected impurities. Regular audits, rigorous testing, and careful selection from approved suppliers help manufacturers prevent supply disruptions and protect end users.
Many processors have started auditing their supply chains for sustainable sourcing and lower environmental impact. Since Glyceryl Mono- And Distearate comes from vegetable oils or animal fat, consumer demand for plant-derived and traceable sources keeps rising. Reputable manufacturers invest in energy-efficient production, minimize chemical waste, and offer transparent documentation of each lot’s origin. Waste from expired batches or out-of-spec material typically heads to safe disposal streams, following local and international laws, so that environmental impact stays minimal.
For any organization making oral, topical, or parenteral medicines, Glyceryl Mono- And Distearate BP EP USP delivers reliability, safety, and the physical characteristics needed for tight process control. Technical teams can count on this ingredient’s well-documented structure, clean record under global regulatory standards, and adaptability across a wide range of pharmaceutical forms. By following strict quality, sourcing, and safety practices, companies keep both their processes efficient and their consumers protected from harm.
Chengguan District, Lanzhou, Gansu, China
