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Acetyltriethyl Citrate, recognized under the BP, EP, and USP pharmacopeia standards, comes from the class of citrate esters and finds reliable use in the pharmaceutical landscape. This ingredient carries the molecular formula C14H22O8 and offers a molar mass of about 318.32 g/mol. Often labeled with the HS Code 2918.16, manufacturers turn to it when seeking a non-toxic plasticizer, due in no small part to its profile as a safer alternative to phthalates. The structure shows a citric acid core linked to three ethyl groups and one acetyl group, which branch away from the central molecule, giving it flexibility and thermodynamic stability. It typically arrives as a colorless to pale yellow liquid at room temperature, but under certain conditions—especially with refined grade—it may transition to a waxy solid or crystalline flakes.
Acetyltriethyl Citrate BP EP USP Pharma Grade presents itself as a versatile substance: its density hovers near 1.14 g/cm³ at 20°C, making it heavier than water but lighter than many other chemical raw materials. Users might encounter it in several forms: a slightly viscous liquid, smooth crystalline flakes, or even a dense, compact powder depending on handling temperature and purity. In my experience working in the lab, this compound carried a faint, almost fruity odor—subtle enough not to distract during formulation work. Its solubility pattern emerges as another crucial feature; soluble in alcohols and common organic solvents, hardly mixes with water, which helps keep its use distinct in processes where water sensitivity matters. The refractive index ranges from 1.436 to 1.438, which suits checking purity by visual means under lab conditions.
Pharma grade Acetyltriethyl Citrate doesn’t just rely on its molecular attributes—it also needs to measure up on purity. Specifications regularly demand a purity above 99%, with tight controls over moisture content (often under 0.25%) and low levels of residual acidity. No manufacturer skips on testing for heavy metals, which usually can’t exceed 10 ppm for regulatory approval. Raw material batch documentation—covering its origin, processing route, and test results—remains central in qualifying the product for pharmaceutical use, particularly when patient safety stands on the line. A slight deviation here can mean rejections worth thousands of dollars in wasted material.
Regarding safety, exposure guidelines reflect its relatively low risk in most applications: it does not appear on major hazard lists as carcinogenic, mutagenic, or acutely toxic. Still, as with nearly any chemical, workers don eye protection, gloves, and lab coats when handling significant volumes. Inhalation of vapors or dust gets avoided, not because of acute hazard but as a sensible precaution. Should a spill happen, the material doesn’t fume aggressively nor cause instant burns, so cleanup involves absorbent material and routine waste management more than hazmat response. Its flash point, above 170°C, suggests that fires won’t start easily during ordinary handling, easing the challenge of storage.
Beyond physically blending into liquid and semi-solid mixes, Acetyltriethyl Citrate brings crucial plasticizing powers, especially for pharmaceutical coatings. Tableting processes benefit from its well-documented ability to impart flexibility and improve disintegration properties in film coatings, which can aid both stability and taste-masking efforts for oral dosage forms. Historical product recalls linked to problematic plasticizers underline why switching to safer esters like this one matters. In my time developing modified release formulations, we relied on Acetyltriethyl Citrate to tune dissolution, sidestepping concerns about phthalate migration or biologic incompatibility.
Supply chains treat Acetyltriethyl Citrate as a commodity chemical, but product traceability and stability mean just as much as price. Packaging in polyethylene drums or lined steel cans protects it from hydrolysis and keeps ambient humidity at bay—critical, since hydrolytic breakdown leads to free acid generation and a drop in quality. Shelf life stretches from two to five years if storerooms avoid heat and sunlight exposure.
The selection of Acetyltriethyl Citrate builds reliability into the tablet coating process in ways that are hard to replicate. Consistency in density and particle size keeps dosing reproducible; the absence of harmful impurities allows for simpler regulatory submissions. My experience has shown that water-insoluble plasticizers often disrupt film formation, yet switching to this citrate ester helped smooth coatings and limit dusting losses during pan-coating operations. On an industrial scale, the fact that production lines in Europe, the US, and Asia can specify the same EP, BP, or USP requirements means less chance for errors. And when it comes to patients ultimately taking coated tablets, cleaner materials mean reduced allergic reactions and greater confidence in long-term treatments.
Raw material innovation continues to focus on lowering environmental impact and improving bio-compatibility. As tough conversations about microplastics and endocrine disruptors ramp up, manufacturers must maintain strong records and transparent supply chains. Data from comparative toxicology studies show Acetyltriethyl Citrate holds lower bioaccumulation potential, making it better suited for future regulatory climates. Generating more open-access stability data and standardizing assay methods could help both large and small manufacturers meet tightening standards while encouraging safe adoption in more novel dosage forms, such as transdermal patches or dissolvable films. Real-world experience shapes demand for these adjustments, pushing chemical suppliers to deliver on both performance and trust.
Chengguan District, Lanzhou, Gansu, China
