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Butylparaben BP EP USP Pharma Grade stands out as a high-purity chemical widely trusted across pharmaceutical, cosmetic, and personal care industries. This compound belongs to the family of parabens, used primarily as a preservative. Chemically known as butyl 4-hydroxybenzoate, it holds a molecular formula of C11H14O3 with a molar mass of 194.23 g/mol. The typical grade designed for pharmaceutical applications meets rigorous BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) quality standards. Each batch often comes with certifications that guarantee compliance with these standards, reflecting the focus on purity, identity, and safety required in medicine and high-care sectors.
At room temperature, butylparaben usually forms as a white or off-white crystalline powder, although suppliers can provide it as fine flakes or small solid pearls depending on process needs. Even though it shows a crystalline structure, it remains easy to crush or dissolve. The density typically hovers around 1.24 g/cm³ at 20°C, making it denser than most organic powders, with a melting point that falls in the range of 68°C to 72°C. The chemical structure includes a benzoic acid core bonded to a butyl ester, making this molecule both lipophilic and moderately soluble in alcohol or organic solvents, though its solubility in water remains on the low side. Material safety data will indicate moderate volatility, negligible vapor pressure at ambient temperatures, and a log P (octanol/water) value that gives insight into its partitioning behavior in different environments.
Butylparaben BP EP USP Pharma Grade serves multiple industries by providing reliable antimicrobial and antifungal activity, which helps products last longer and reduces the chances of microbial contamination. In the pharmaceutical sector, it works as an effective preservative in creams, ointments, and solutions, preventing the growth of bacteria and mold without breaking down or losing function over time. I have noticed in manufacturing environments that the consistent, high quality of pharma grade ensures the end product's safety, critical for medicines reaching vulnerable populations. Cosmetic manufacturers depend on butylparaben’s stability and neutral odor, supporting preservation in lotions, shampoos, and makeup, where microbial stability makes or breaks a brand’s trust among customers. Each manufacturer relies on the predictable behavior of pharma-grade material, knowing subpar quality can trigger recalls, regulatory action, or even harm to end-users.
The product arrives with complete documentation—Certificates of Analysis and Safety Data Sheets—clarifying details such as purity, typically above 99%, water content less than 0.5%, and specific identification results by infrared spectroscopy. The HS Code for butylparaben traded as a pharmaceutical raw material lands under 2918290090. Regulatory agencies in the European Union, United States, and beyond set strict limits on use levels in finished products. In the EU, for example, parabens like butylparaben hold allowable concentration limits, with close monitoring for potential sub-chronic exposure risks. The US FDA recognizes it as Generally Recognized as Safe (GRAS) for certain uses, provided concentrations align with guidance. All these checks ensure products leaving the factory remain safe throughout their intended shelf life and pose minimal risk when applied as directed.
Even though butylparaben’s toxicological profile is well understood, good handling procedures matter at every touchpoint. Direct exposure in powdered or particulate form can cause skin or eye irritation, so gloves and goggles become essential in production. SWA, OSHA, and ECHA advisories all highlight the importance of well-ventilated workspaces and the avoidance of fine dust inhalation. Environmental groups keep a close watch on parabens due to possible endocrine disruption in aquatic life. As a result, responsible manufacturers focus on effluent treatment and waste management to keep butylparaben out of rivers and groundwater. Packaging often includes tamper-evident closures and clear hazard labeling, teaching handlers and users to respect the material’s potential without fearing its routine, regulated use.
Sourcing butylparaben in pharma grade starts with rigorous selection of benzoic acid and butanol, the primary building blocks. Each undergoes esterification, a process that must be tightly controlled to prevent contamination and guarantee proper conversion. Facilities meeting Good Manufacturing Practices (GMP) use stainless steel reactors and continuous monitoring instruments to keep byproducts at bay. Supply chain transparency means every link provides traceability, allowing problem batches to be isolated before they can enter product lines. In my experience, the global move toward sustainable sourcing encourages more suppliers to invest in green chemistry routes, using renewables or lower-impact methods wherever possible to keep both the environmental and safety footprints as small as possible.
Concerns have risen around the long-term environmental impact of widespread paraben use, so companies explore alternatives or blends that lower the need for any one preservative. Continuous improvement in analytical techniques—like high-performance liquid chromatography (HPLC)—helps in detecting even minute impurities, giving quality teams faster response times to address deviations. I have seen forward-looking firms engage with academic research to find or develop safer, more biodegradable preservatives while maintaining the functional benefits of butylparaben. Open dialogue between regulators, producers, and the scientific community leads to shared best practices around safe use, improved labeling, and innovative formulation that meets both customer trust and environmental obligations without sacrificing product quality.
Chengguan District, Lanzhou, Gansu, China
