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Glyceryl Behenate BP EP USP Pharma Grade is a chemical compound used in the pharmaceutical and nutraceutical industries as an excipient and lipid matrix. Known under the chemical name glyceryl dibehenate, this raw material comes from the reaction of glycerol and behenic acid, resulting in a blend of mono-, di-, and tribehenate esters. The product serves as an essential ingredient for controlled-release drug delivery, taste-masking, and coating applications in tablet and capsule formulations. These roles support predictable absorption rates, protect sensitive active pharmaceutical ingredients, and enhance patient compliance.
Glyceryl Behenate BP EP USP presents as a white to off-white, waxy solid at room temperature. The physical state can range from fine powder, small solid flakes, and granulated pearls to a crystalline mass, depending on manufacturing needs and the desired processing characteristics. In direct compression processes, its flaked form offers easy handling, while powder or pearl shapes allow for simple blending in high-shear mixing. This substance has a faint, neutral odor, ensuring no taste or smell interference with oral medications. The chemical remains stable in ambient temperatures and resists oxidation or hydrolysis, securing a long shelf life under proper storage conditions.
Glyceryl Behenate carries the molecular formula C69H134O6 and a molecular weight of approximately 1079.8 g/mol. Its structure supports a unique combination of hydrophobic long-chain fatty acids and the glycerol backbone, leading to finely tuned melting points and viscosity. Typically, it shows a density close to 0.95 g/cm3 at 20°C, which impacts granule flow, compaction, and the final architecture of tablets and pellets. This density, lower than many inorganic excipients, helps maintain controlled-release features by moderating water penetration and drug dissolution rates after administration.
Available in a range of forms for industrial scalability, glyceryl behenate appears as flakes, fine powder, solid masses, and occasionally as pearl-like granules. These various forms stem from specific production techniques, driven by the target dissolution rate and dosage form design. The melting point generally falls between 69°C and 74°C. The substance remains insoluble in water but dissolves readily in organic solvents like chloroform and hot ethanol. This insolubility means glyceryl behenate creates effective barriers in controlled-release matrices and lipid-based coatings. The material’s texture and crystalline stability support robust tableting without risk of capping, lamination, or friability in compressed forms.
Hygiene and safety matter to every operator who comes into contact with pharmaceutical additives. Glyceryl behenate BP EP USP qualifies as a non-toxic and non-irritant compound, supported by both pharmacopoeial and toxicological assessments. Under normal conditions, it does not count as a hazardous material by major regulatory standards. No significant vapor emission or dust toxicity occurs during handling, making personal protection measures straightforward: gloves, dust masks, and clean work areas. Manufacturing lines see minimal risk of worker exposure or process contamination. The compound’s classification as food-grade and pharmaceutical safe confirms its acceptance by agencies such as the US FDA and the European Medicines Agency.
Manufacturing certifications and specifications give reassurance to buyers and pharmacists about the consistency and safety of the excipient. Products meeting BP, EP, and USP standards exhibit acid value between 2 and 6 mg KOH/g, saponification value from 180 to 195 mg KOH/g, and a melting point as noted before. The residue on ignition stays well under 0.1%, indicating minimal impurity by weight. Heavy metals remain undetectable or within safe concentration thresholds defined in global monographs. No solvents or volatile organics appear at harmful concentrations in finished batches. Certificates of analysis and regulatory dossiers often supply detailed analysis for every lot shipped, offering full traceability and confidence in quality control processes.
For international logistics and compliance, glyceryl behenate carries the HS Code 2916.39, classifying it within the group of esters with pharmaceutical and cosmetics applications. Reliable coding supports easy customs clearance, freight calculations, and tariff declarations. This clarity simplifies global supply chain management, especially since many of the world’s pharmaceutical manufacturing operations source their raw materials from multiple locations in Europe, Asia, and North America. HS coding also ties into import-export documentation, shipment tracking, and risk management across jurisdictions.
Raw material quality shapes every pharmaceutical excipient’s performance. High-purity behenic acid feeds the esterification process, typically derived from natural plant oils such as rapeseed and peanut. Food-grade glycerol, sourced from vegetable or animal fats, rounds out the key ingredients. Responsible manufacturers emphasize traceable supply chains, renewable agriculture, and controlled processes, showing a commitment to environmental protection and product integrity. This approach supports not only safety and label compliance but also strengthens market trust for companies marketing “clean label” or sustainable pharmaceutical ingredients.
In active use, glyceryl behenate BP EP USP shapes the foundation for extended- and controlled-release tablets, pelletized dosage forms, and medicated granules. Its ability to slow water ingress and modulate active ingredient release lets pharmaceutical chemists fine-tune a patient’s absorption profile. This feature reduces the peaks and valleys in plasma concentration, leading to fewer side effects and improved therapeutic results. In taste-masking, glyceryl behenate forms a lipid matrix around bitter actives, making medications more palatable to children and sensitive adults. In topical and cosmetic formulations, the compound acts as a thickener, emollient, and stabilizer, adding value to diverse personal care products outside of medicine.
Glyceryl behenate BP EP USP Pharma Grade stands out for its robust functionality, safe profile, and adaptability in pharmaceutical manufacturing. From the chemical structure, physical form, and solubility to the regulatory standards and international movement codes, every property answers real needs in modern drug development and delivery. The reliability of supply, rigorous specifications, and the ongoing trend toward sustainable sourcing only add to its standing as an industry staple. Key to advancing reliable, consistent, and safe medicine, glyceryl behenate continues finding new uses and playing a crucial role in patient health and well-being as pharmaceutical science evolves.
Chengguan District, Lanzhou, Gansu, China
