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1,3-Butanediol BP EP USP Pharma Grade defines a specific purity level of 1,3-Butanediol, shaped to meet the standards of British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). Each standard demands low impurity levels, clear documentation, and consistent performance. Used widely in pharmaceutical manufacturing, skincare formulation, and specialty raw goods, 1,3-Butanediol presents as a colorless, nearly odorless liquid with a mild, sweet taste. The consistent viscosity and fluidity make it easy to handle in both laboratory and industrial settings. This chemical supports multiple applications, acting as a humectant, solvent, and intermediate. Pharmacies and large healthcare manufacturers rely on its stable molecular structure to deliver reliable results batch after batch, maintaining safety and efficacy for end users.
The molecular formula of 1,3-Butanediol reads as C4H10O2. Looking closer, the structure holds two hydroxyl (–OH) groups attached to a four-carbon backbone at the first and third positions. This arrangement gives the molecule its diol characteristics—offering both water solubility and chemical reactivity. At a molecular weight of about 90.12 g/mol, the compound fits squarely within the range required for versatile synthesis or direct use in complex solutions. Every batch undergoes rigorous analysis, confirming the arrangement and consistency within tight boundaries defined by pharma-grade specifications. These standards, aligned with BP, EP, and USP, lower the risk of variable reactions or contamination. People in chemical processing or raw material sourcing appreciate the reliability this structure provides—ensuring their end products consistently meet quality demands.
1,3-Butanediol stands as a highly water-soluble liquid, showing complete miscibility with water and many organic solvents, including ethanol and acetone. The refractive index sits typically around 1.4400 to 1.4470 at 20°C, demonstrating optical clarity prized in analytical and formulation work. Thermal stability covers a broad range—most often, the boiling point falls near 207°C, with a melting point slightly below room temperature, making it convenient for both ambient and moderately elevated temperature processing. The density measures about 1.004–1.007 g/mL at 20°C. That density ensures predictable dosing in both gram and liter measurements, supporting formulation work on any scale. Its low vapor pressure at room temperature limits evaporation loss, a feature appreciated by those who must keep inventory tightly monitored. Surface tension hovers around 30–40 mN/m, granting smooth mixing into water-based solutions or gels. The degree of purity, often hitting numbers above 99.5%, rules out most trace contaminants or by-products that would otherwise hinder fine pharmaceutical manufacturing.
Often, 1,3-Butanediol appears as a clear, viscous liquid, though some suppliers provide flakes, solid pieces, tiny pearls, fine powders, or crystalline forms, each supporting unique handling setups. The solid forms tend to pack tightly to maximize storage, while liquid batches pour quickly and integrate easily in blending tanks or reactors. Tactile feeling can range from slippery for the liquid to chalky or granular if formed as a powder or flake. For pharmaceutical-grade lots, the product shows complete absence of visible particulate or color, marking purification steps that set it apart from industrial or technical grades. Some users require the liquid for direct blending; others choose crystals or powders to assess precise solubility or avoid unwanted dilution. Transportation often involves sealed polyethylene drums for liquids or robust bags and containers for solids, marked by their hazard warnings and batch lot numbers for traceability.
Specification runs tightly controlled: Purity often tests at ≥99.5%. Water content, measured by Karl Fischer titration, stays minimal, typically under 0.5%. Acidity, determined by titration, reads almost neutral, seldom above 0.05% as acetic acid equivalents. Metals and residual solvents follow strict cutoffs, reflecting official compendia, protecting both end-user safety and downstream quality. Appearance, residual impurities, specific gravity, refractive index, and other analytical data stay consistent, enabling traceability and compliance for regulatory audits. Laboratories and factories depend heavily on these numbers, anticipating regulatory scrutiny or batch repeats.
The density—about 1.004 to 1.007 grams per milliliter for liquid; bulk density may shift for powder or crystal forms—dictates not just packaging but also flow characteristics in pipelines or mixing machines. Density guides dosing, especially when high-precision batches must be measured and dispensed by volume rather than mass, or vice versa, depending on equipment at hand.
Shippers and customs agents assign 1,3-Butanediol the HS Code 29053990 under the broader family of diols, still keeping it specific enough for traceability. This code follows the Harmonized System, making reporting and import-export documentation simpler and trusted worldwide. Distributors and buyers can track every pallet, every shipment, and every customs declaration through this identifier, helping ensure the product fulfills every labeling and compliance requirement across different jurisdictions.
In everyday processing, 1,3-Butanediol works as a foundational raw material, serving in active pharmaceutical ingredients, excipients, and intermediates for synthesis. The product bridges raw material and finished ingredient roles. Chemists seeking performance often prefer it over other diols due to the balance of hydrophilicity and workable viscosity—easy to dissolve, easy to meter, slow to degrade. Its hygroscopic character means it’s good for moisture retention in creams or gels, and as an intermediate, it reacts predictably with acids or acetals. As a raw material, it supports soap-free emulsions, fine-tuned drug-delivery vehicles, or as a carrier in new excipient development. Raw material buyers keep close tabs on batch traceability and supply chain integrity, especially when the product moves between regions or regulatory bodies.
1,3-Butanediol BP EP USP Pharma Grade, though safer than many solvents, still demands careful attention. Inhaling mists or vapors for extended periods can irritate eyes, lungs, and skin. Adverse effects seldom occur at routine exposure levels, yet chronic contact or excessive ingestion carries risk, potentially impacting central nervous function or causing gastrointestinal upset. No one can ignore storage guidelines: the chemical stores best in tightly closed containers, far from heat, direct sunlight, or oxidizing agents. Spills or leaks need speedy clean-up using standard absorbent materials—wipes, sand, or spill kits. Facilities should always post Safety Data Sheets (SDS) and train staff on best response to accidental exposure. Gloves, goggles, and lab coats reduce skin or mucous membrane contact. Waste disposal follows chemical waste regulations, ruling out sanitary or storm drain disposal. Environmental teams track all discharges, knowing regulations penalize improper disposal—especially for products tagged as hazardous under global treaties or local law.
Use of 1,3-Butanediol in pharmaceutical settings often meets tight environmental controls. Release into the environment stays limited—not just by internal company policy but also by regulatory agencies that demand full tracking from shipment to end use. Both the EU and FDA review impurities and residual solvents for each batch, watching for risks to consumers and workers. As a raw material, it doesn’t persist long in air or water, but responsible handlers limit emissions regardless. Safe disposal, controlled use, and diligent record-keeping remain industry standards, not just guidelines. Audits, both surprise and scheduled, keep facilities alert to lapses or oversights. Waste streams get sampled, monitoring for minute traces that might escape routine filters.
For many years, supporting safe and cost-effective use of 1,3-Butanediol meant adopting strict quality assurance systems, embracing digital lot tracking, and investing in regular third-party audits. Modern facilities build closed-loop transfer systems, limiting airborne exposure and spills. Training remains consistent—new hires get onboarding courses covering chemical hygiene, and seasoned staff refresh knowledge through drills and courses. To reduce risk further, some companies design in secondary containment for storage tanks or keep neutralizing agents ready in storage bays. Laboratories run continuous cross-checks for product purity and specification alignment well beyond regulatory minimums. This approach keeps recalls rare and customer trust high. Clean labeling, accurate SDS data, and direct supplier relationships all buffer against supply chain disruptions or the appearance of unverified inputs. People who ship or store the material stick with clear labeling and secondary locks, lowering unauthorized access risk.
Chengguan District, Lanzhou, Gansu, China
