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Diethyl Phthalate BP EP USP Pharma Grade: Properties, Structure, and Specifications

What is Diethyl Phthalate BP EP USP Pharma Grade?

Diethyl Phthalate, often found under the names BP, EP, or USP Pharma Grade, comes from the phthalate family. It features a clear, colorless liquid form under standard laboratory conditions. Chemically, this compound uses ethanol esterified with phthalic acid, bringing the molecular formula C12H14O4 and a molecular weight of about 222.24 g/mol. The liquid shows low volatility and a faint, slightly floral odor, known to those familiar with chemical labs. Whether it lands in a pharmaceutical, cosmetic, or industrial setting, this compound shares a consistent appearance: transparent, free from visible foreign matter, and neither oily nor tacky to the touch. Diethyl Phthalate, regulated by BP, EP, and USP monographs, must maintain high purity and follow strict guidelines on heavy metals, water content, and acid value.

Physical and Chemical Properties

Diethyl Phthalate, in pharma grade, stands out with a specific density ranging between 1.117 and 1.121 g/cm3 at 25°C. This density gives it a palpable weight that laboratory glassware reveals in practice. It melts only below freezing, with a measured melting point close to -3°C, and boils around 298°C, making it robust in liquid form throughout the manufacturing process. With solubility properties favoring organic solvents rather than water, Diethyl Phthalate dissolves easily in ethanol, ether, and acetone, but only sparingly in water, which matters in mixture preparation and phase separation. Its viscosity remains moderate, and the refractive index falls between 1.500 and 1.504, more noticeable during quality checks with refractometers. This compound remains quite stable when stored away from heat, oxidizers, and flames.

Material Forms and Appearance

Almost always, Diethyl Phthalate BP EP USP Pharma Grade arrives as a pure, clear liquid, neither powdery, crystalline, nor pearlescent. The clear liquid makes it easy to filter and check for contaminants, both visually and with instrumentation. Though phthalates sometimes show as flakes or solids in industrial-grade chemistry, pharma grade Diethyl Phthalate stays liquid for dosing accuracy. Its flow, viscosity, and handling properties set it apart from sticky or powdery materials, making spills easier but calling for careful handling to prevent inhalation or skin contact.

HS Code and Regulatory Status

Traders and logistics specialists use HS Code 2917.39.90 for Diethyl Phthalate. This code classifies it alongside other esters of phthalic acid, covering customs control and regulatory reporting in the global trade of pharmaceutical raw materials. This particular compound, classified under various national and international rules, gets scrutiny from regulatory agencies that oversee import, transport, and manufacturing, especially in applications touching medical, food, or hygiene sectors. Compliance means sticking to everything from purity specifications to safe packing and documentation. The product’s documentation typically lists batch analysis certificates, residual solvent levels, and data about toxic elements, protecting manufacturers and users throughout the supply chain.

Structure and Molecular Formula

A closer look at the chemical structure shows two ethyl groups attached to the aromatic phthalate ring through ester linkages. Each molecule consists of a benzene ring with carboxylic acid esters on the ortho positions, each bonded to an ethyl chain, making the molecule both flexible and hydrophobic. This structure changes how the compound interacts with other substances, especially in drug formulation, flavor encapsulation, or plastics plasticizing. The chemical structure also means the molecule can act as an inert carrier or solubilizer for some sensitive pharmaceutical ingredients. Handling the raw material safely requires understanding that its ester bonds, though stable, can hydrolyze under strong acid or base, but not under neutral conditions, making storage and formulation less complicated than some alternatives.

Safety, Hazards, and Material Handling

Working with Diethyl Phthalate in pharma environments puts safety into sharp focus. The liquid is not considered acutely toxic, though it still carries hazard statements about skin and eye irritation, especially after repeated exposure. Direct inhalation of vapors or prolonged direct contact can irritate human tissue, especially for laboratory or factory workers spending full shifts near open containers. It lacks flammability under normal conditions, but like many organics, it burns with enough heat—making good storage away from ignition sources important for large volumes. The Safety Data Sheet (SDS) describes standard precautions: wear nitrile gloves, use protective goggles, work in a well-ventilated area, and avoid direct contact. Waste management should meet local environmental rules, as this chemical, while less persistent than some longer-chain phthalates, can break down slowly in groundwater or soil, bringing eco-toxicological concerns.

Applications and Raw Material Use

Diethyl Phthalate BP EP USP Pharma Grade functions mostly as an excipient, solvent, or plasticizer in pharmaceuticals. Its use in oral drug coatings or capsules calls for a product free from unwanted impurities, giving patients a safe route for medication intake. In perfumes or topical formulations, its mild odor and compatibility with other organics make it a steady carrier for fragrances or actives. I have seen this compound take center stage in lab benches where professionals want solutions that dissolve quickly but leave no sticky residue or aftertaste. In tablet films and controlled-release matrices, its behavior under pressure and heat delivers precise dosing and shelf stability. Sourcing the raw material must focus on keeping batch-to-batch variation low, since even small levels of contamination can threaten product safety.

Quality Specification and Analytical Methods

Quality tests for Diethyl Phthalate pharma grade involve many analytical checks, including water content by Karl Fischer titration, acid value by standard titration, and GC-MS to catch impurities. Specifications under BP, EP, and USP standards include color, odor, specific gravity, refractive index, and chromatographic purity. Pharmaceutical manufacturers depend on these details to match formulas and regulatory expectations. For end uses involving human health, every supplier batch comes with a Certificate of Analysis showing results for each critical test, reducing risks for manufacturers and end users.