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Butyl P-Hydroxybenzoate BP EP USP Pharma Grade: Physical Characteristics and Industry Significance

What is Butyl P-Hydroxybenzoate?

Butyl P-Hydroxybenzoate, better known in the industry as butylparaben, belongs to the family of parabens, substances widely used for their preservative qualities. Factories, pharmaceutical makers, and cosmetic companies often rely on this compound for its ability to prevent fungal and bacterial growth. Butylparaben appears in finished formulations in everything from pharmaceuticals to personal care items. Understanding its core features and the science behind its role tells you why so many global workshops and quality labs depend on high-purity batches, made to BP, EP, and USP grades.

Molecular Structure and Formula

Chemists recognize Butyl P-Hydroxybenzoate by its chemical formula C11H14O3. At the molecular level, its design brings together a phenolic ring with a butyl ester group, creating a structure that resists degradation in a wide range of environments. The International Union of Pure and Applied Chemistry places its systematic name as Butyl 4-hydroxybenzoate. Take a closer look and you'll see an aromatic ring with a para-hydroxy substitution, which connects via an ester link to a straight-chain butyl group. This configuration ensures performance, shelf life, and safety in pharmaceutical and cosmetic applications.

Physical and Chemical Properties

Butylparaben usually shows up as a white crystalline powder, though flakes and occasionally small pearls turn up during high-volume processing. Feel it, and its texture runs smooth rather than gritty, giving it an advantage when dispersing in a cream base or tablet blend. Its melting range lands between 68°C and 72°C—a factor that ensures stability at room temperature yet allows easy integration into melted formulations. Solubility challenges pop up in water, as it dissolves only sparingly, around 0.04 g per 100 mL at 25°C. Move to common solvents and you'll see much greater compatibility; ethanol, acetone, and ether handle this molecule well. The density sits near 1.13 g/cm³, important for dosing and quality control. Its seemingly straightforward makeup hides a well-engineered combination of hydrophobic and hydrophilic properties, which help strike a balance between effective microbial action and compatibility in water or oil-based preparations.

Specifications and Raw Material Handling

Industry standards for BP, EP, and USP grades demand limits on organic impurities, identity confirmation, and compliance with purity requirements. Residual solvents or heavy metals can’t slip into the finished product. Typical assay values land between 99 and 100.5 percent, checked by high-end analytical equipment such as HPLC or titration. Moisture content stays below 0.5 percent, so the powder never clumps or cakes during storage. The HS Code for Butyl P-Hydroxybenzoate usually falls under 2918.23, lined up among carboxylic acid derivatives. Professional storage keeps this raw material in tightly sealed drums or bags, away from direct light and moisture, usually at temperatures below 30°C. This attention to logistics keeps big production lines running smoothly without quality incidents.

Material Safety and Health Considerations

Safety always matters when handling bulk chemicals. Butylparaben delivers moderate toxicity levels if swallowed or inhaled, so plant workers always follow protocols and use proper personal protective equipment. Repeated skin contact might set off allergic reactions for some, but it presents much less risk than more aggressive preservatives. Its hazard designation ranks as irritant rather than corrosive or acutely toxic. GHS labeling typically includes exclamation marks and advice on rinsing with water on contact. Environmental studies show that butylparaben, like other parabens, breaks down slowly in waterways, so some countries regulate discharge and disposal carefully to cut down on ecological impact.

Typical Forms and Pharmaceutical Relevance

The pharma grade usually comes as a free-flowing powder, but bona fide suppliers stock it as flakes, sometimes pearls, or even in crystalline form for precise weighing and transfer. In the plant, you might see it being measured by the drum or decanted into smaller lots for R&D. Its defined melting point, density, and moisture limits support strict needs for process validation. The pharma industry doesn't give passes on quality, so producers send samples for independent verification, making sure not just the active percentage, but also critical parameters like purity, trace metals, and residue solvents make the cut. Its role as a preservative links directly to enhanced product shelf life, giving finished drugs or creams a warranty against spoilage. That keeps end consumers safe and cuts costs for manufacturers wary of losses from returns or recalls.

Industry Solutions and Ongoing Research

Stepping into 2024, more companies search for greener alternatives and safer preservation solutions after hearing concerns around potential health risks of parabens. Studies haven't confirmed serious issues at pharmaceutical concentrations. Still, regulatory agencies in regions like the EU and the US ask for transparency and full disclosure of concentrations. Manufacturers and formulation experts keep tabs on emerging research, exploring possibilities like blending several preservatives to use lower overall concentrations. Meanwhile, improved synthesis routes reduce residual solvents, trim down heavy metal content, and slash water use in manufacturing. These efforts, combined with tight control over grade, form, and packaging, drive up safety and sustainability for Butyl P-Hydroxybenzoate moving forward. If the industry holds to strong science and open dialogue, this molecule will stay a mainstay at least for the foreseeable future.