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Triethyl O-Acetylcitrate goes by several names in the industry, but most people in pharmaceutical manufacturing know this chemical as a trusted plasticizer or excipient. It comes from citric acid and helps tweak how everything from pills to packaging handles harsh environments. Its molecular structure is C14H22O8, straightforward enough for most chemists – three ethyl groups hanging off a citric acid core with an acetyl cap. This set-up gives it stability, flexibility, and the ability to dissolve a wide range of substances. It turns up as a colorless to pale yellow liquid, sometimes looking slightly oily, with a density that hovers close to 1.135 grams per cubic centimeter. That puts it right in the expected range for materials that blend well without causing clumping or caking in powdered mixes. When you pour it, it flows smoothly, no crystals or chunks getting in the way.
Let’s break down the specs that matter: Triethyl O-Acetylcitrate has a molecular weight of 318.32 g/mol, sitting comfortably in the range for materials that disperse evenly without evaporating too fast. The boiling point lands at around 402°C, well above anything standard pharmaceutical processes throw at it. It doesn’t freeze up until about -20°C, making it stable for transit and storage through most climates. Water solubility is low, so you won’t see it dissolve right into your aqueous mixes, but it blends well with alcohols, esters, and common organic solvents. This means it can do its job as a plasticizer without leaching out or compromising structural integrity. The product can show up in different forms: liquid remains the standard, though sometimes people see it marketed as a thick syrup or in pearls when dealing with large-scale industrial supply.
Pharmaceutical use demands attention to purity, especially in BP, EP, and USP grades. These certifications mean the triethyl o-acetylcitrate passes tests on heavy metals, residue on ignition, and acid value. Assay requirements demand a minimum content, usually no less than 98%, because impurities can compromise the safety profile of the finished drug. HS Code 29181500 classifies this compound under esters of citric acid, which simplifies regulatory paperwork for international shipments. Each batch needs a Certificate of Analysis to confirm it meets the pharmacopoeia specifications. In a real manufacturing setup, the certificate means less worry over contamination or unexpected reactivity.
Manufacturers rely on Triethyl O-Acetylcitrate for a reason: it softens brittle polymers in pill coatings, ensures tablets stay together during transit, and keeps capsules smooth enough to swallow. Anyone in the tableting business knows what happens when coatings crack – the whole batch can go to waste. This compound helps bind ingredients without interfering with the active pharmaceutical ingredient. Outside tablets, it serves as a plasticizer in medical polymers and even some bio-based packaging, extending shelf-life and protecting sensitive ingredients from moisture. It keeps the shape and resilience of medical devices, from diagnostic strips to certain types of IV bags, where flexibility and durability are key to preventing tears.
Safe handling stands front and center with any pharmaceutical raw material, and Triethyl O-Acetylcitrate is no different. On the safety data sheet, it does not fall under the hazardous or harmful category at the usual exposure levels – not flammable, no known persistent toxic effects, and not classed as a skin irritant under most modern guidelines. This lowers the risk of regulatory headaches during manufacturing. Still, it makes sense to use gloves and goggles, as with any raw chemical, to avoid direct skin contact and accidental splashes. Though spills don’t create a serious hazard, a good clean-up protocol keeps residues out of unintended places, especially if you’re running a cleanroom.
In the global supply chain, reliable access to Triethyl O-Acetylcitrate means looking for suppliers that understand stable storage. The chemical stays stable in standard drums or HDPE containers, as long as you keep it dry and away from direct sunlight. Long exposures to temperatures above 40°C can nudge it past its comfort zone, leading to gradual yellowing or degradation, so climate control matters. Whether you’re filling smaller bottles or unloading multi-ton shipments, attention to air-tight seals prevents any slow absorption of moisture that could affect its physical properties. In my experience, good communication with logistics partners and regular quality checks on incoming raw materials prevent production stop-gaps and keep compliance issues from creeping up.
Scaling for demand remains a challenge in pharmaceutical raw materials. Volatility in global sourcing, stricter product recalls, and new environmental standards all impact how companies approach their supply relationships. Establishing more regional hubs for quality certification and testing could help. At the same time, the market keeps pushing for alternatives with even higher biocompatibility and better lifecycle profiles. Ongoing research in green chemistry offers promise – improved synthesis routes for Triethyl O-Acetylcitrate could cut down on waste, greenhouse gases, and production costs. Companies investing in traceability systems find benefits in faster recalls, streamlined audits, and more resilient responses to sudden regulatory changes. It’s clear that beyond chemistry, a transparent and proactive supply chain builds real-world confidence and consistent quality for everyone – chemists, operators, and patients alike.
Chengguan District, Lanzhou, Gansu, China
