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Glycerol Monooleate BP EP USP Pharma Grade serves as a valuable material across pharmaceutical manufacturing. Made from the reaction of glycerol and oleic acid, this compound presents a unique molecular structure. With a chemical formula of C21H40O4 and a molecular weight of 356.54 g/mol, glycerol monooleate takes the form of a monoglyceride ester. CAS Number 25496-72-4 further identifies the material for regulatory and quality purposes. As someone who has spent years watching labs and processing facilities handle a wide range of excipients, I have seen professionals rely on this raw material for its functional properties, blending capacity, and compatibility with modern formulations. Its physical characteristics make it a favorite for many teams handling solid and semi-solid dosage forms.
You’ll encounter Glycerol Monooleate BP EP USP Pharma Grade in several forms—most often as flakes, powder, pearls, or a viscous liquid. These visual cues give insight into the handling and storage needs of the material. With a specific density usually sitting around 0.96–0.98 g/cm³ at 25°C, its structure consists of an ester bond between a single fatty acid (oleic acid) and the glycerol backbone, which supports emulsification and surface activity in finished pharmaceutical products. Melting points typically land in the 34°C to 38°C range, keeping the product soft, waxy, or oily depending on storage conditions. This flexibility enhances processing, especially in the production of ointments, creams, suppositories, and coated tablets. Seeing formulation scientists use flakes for rapid incorporation or liquids for ease in mixing confirms the versatility rooted in its physical makeup.
A standout feature of Glycerol Monooleate BP EP USP Pharma Grade lies in its multifunctionality. As an emulsifier, stabilizer, and solubilizer, it supports drug delivery and boosts bioavailability by improving the solubility of active ingredients. I’ve witnessed it facilitate the blending of oil and water phases, forming stable mixtures that hold up under storage, transport, and temperature shifts. Industry professionals appreciate that the substance aligns with global quality specifications outlined in pharmacopoeial monographs (BP, EP, USP), which set purity, residual solvent, and heavy metal criteria for safe use. Transparency from suppliers on batch testing and compliance often builds trust at every point in the supply chain.
Globally, Glycerol Monooleate is recognized with an HS Code of 38249090 under chemical preparations not elsewhere specified. This helps with smooth import/export and customs clearance, which saves time and reduces red tape in daily business. Pharmaceutical-grade designation means manufacturers carefully control its production from raw materials to finished product, monitoring for compliance and consistency. Professionals in quality assurance and regulatory affairs rely heavily on certificates of analysis, traceability documents, and safety data—resources that are as much about keeping patients protected as they are about ticking boxes for audits.
In my experience, clear communication about chemical safety always takes priority when evaluating excipients like Glycerol Monooleate BP EP USP Pharma Grade. The Substance is considered low-hazard with minimal acute toxicity. Yet, professionals don’t cut corners: gloves, goggles, and lab coats often remain standard during handling. SDS sheets highlight that, while Glycerol Monooleate does not present notable harmful or hazardous effects under normal use, contact with eyes or ingestion in large quantities may demand medical evaluation. This cautious approach keeps teams working safely and helps companies meet obligations for workplace health under regulations like OSHA or REACH.
Despite its generally safe status, the material is not free from all risk. Batch-to-batch consistency remains a challenge for anyone working with natural-sourced raw materials. Rigorous testing, supplier qualification, and ongoing monitoring give manufacturers tools to mitigate these risks. Another sticking point: sustainability. Sourcing glycerol and oleic acid responsibly can influence the market—watching the shift toward palm-oil-free production or greener processes shows the growing weight of environmental responsibility. As demand for clean label and biodegradable excipients rises, producers should keep aiming for transparency and continual supply chain improvement. Problems such as excessive reliance on a single source or region also spotlight the need for alternative sourcing strategies.
Recent trends in drug delivery—think lipid-based formulations and advanced carriers—underscore the steady demand for multifunctional excipients like Glycerol Monooleate BP EP USP Pharma Grade. Detailed understanding of its density, solution behavior, and compatibility allows formulators to explore complex release profiles or boost API solubility. In my observation, cross-disciplinary learning, with teams from R&D, procurement, and regulatory working together, often leads to better outcomes. Efforts to modernize documentation, automate quality checks, and maintain open communication between supplier and end-user can drive efficiency and safety. Encouraging continuous training and education on excipient science reinforces best practice and underpins product quality in the long run.
Chengguan District, Lanzhou, Gansu, China
