Azone Powder BP EP USP Pharma Grade: Description, Properties, and Key Information

What is Azone Powder BP EP USP Pharma Grade?

Azone Powder BP EP USP Pharma Grade stands out as a chemical compound designed for use in the pharmaceutical world. Its presence in medical formulations traces back to a role in enhancing the penetration of drugs through skin barriers, a breakthrough for transdermal therapies. The material doesn’t just serve as an additive; it shapes the entire way some medications function by increasing access to the tissues that need treatment. In labs and manufacturing settings, the Azone form often defines the success of new delivery systems for both topical and transdermal drug products, shifting the boundaries of bioavailability.

Physical Characteristics and Product Forms

Most commonly, Azone powder appears as off-white to pale yellow crystalline flakes or fine powder, holding a density close to 0.94 g/cm³ at 25°C. Certain batches arrive in solid chunks or as granular pearls, depending on the source and process used during manufacturing. Its melting point hovers near 62-66°C, so in warmer conditions, the compound tends to soften but not liquefy until subjected to higher heat. Some suppliers deliver Azone as a solution, typically dissolved in ethanol or propylene glycol, which eases mixing for specific liquid or semi-solid product formulations. Amid industry trends for more efficient drug delivery systems, Azone’s solid, stable form helps guarantee a reliable shelf life—crystals store well when shielded from excess light and moisture.

Chemical Structure, Formula, and Molecular Properties

Azone’s chemical name, laurocapram, reflects its layered structure: a cyclic amide ring attached to a dodecyl chain. Its molecular formula is C18H35NO, giving a molecular weight around 281.47 g/mol. The key structural element—a seven-membered lactam ring—means the compound has both hydrophilic and lipophilic characteristics. That duality explains why it works so well as a penetration enhancer, slipping between lipid bilayers and temporarily disrupting the skin’s barrier for drug molecules to move through. By closely studying this structure, chemists developed new approaches for dosage forms.

Specifications and Technical Data

Pharmaceutical-grade Azone powder meets strict requirements. Impurities remain under tightly regulated limits. Loss on drying stays under 0.5% to prevent excess water, and identification tests match published spectra for purity confirmation. Heavy metals in certified lots appear well below thresholds set by major pharmacopeias (BP, EP, USP). Packing Azone for pharma use means sealed containers, usually lined with polyethylene bags to block contamination and moisture. The HS Code for Azone Powder sits under 29242995, tracing its trade worldwide as a pharmaceutical raw material and chemical intermediate rather than as a finished medicinal product.

Safety, Hazard, and Handling Considerations

Like all pharmaceutical raw materials, Azone powder carries its own safety profile. Direct skin or eye contact can cause irritation, and dust inhalation during manufacturing warrants respiratory protection. Despite its importance in drug delivery, the material demands careful attention—gloves, goggles, and dust masks should stay within arm’s reach in workspaces using this compound. Some chemical safety sheets warn about combustion risks in finely powdered form. Storage calls for cool, dry places, and any spills get cleaned with adsorbent materials while preventing airborne particles. Azone’s “hazard” category scores low on acute toxicity when handled properly, but the label “harmful if swallowed” persists due to its chemical structure and concentration.

Applications in Pharmaceutical Formulation

Pharmaceutical scientists lean on Azone to solve an old challenge: getting drug molecules past the natural blocks set up by skin. Classic examples include topical creams, gels, and solutions, aiming for faster or more consistent effects. By acting on the stratum corneum, Azone increases fluidity in skin lipids, creating temporary microchannels for medication transit. This property transforms the formulation strategy for anti-inflammatory drugs, hormone replacements, and pain medications alike. It also works in veterinary medicine and cosmetic products, where deep absorption creates a measurable difference in results. For many, Azone powder provides the missing link needed to launch successful new therapies that were once limited by skin absorption issues.

Facts and Insights for Formulators and Buyers

Large-scale buyers regularly ask about the stability of Azone powder—long-term results confirm the compound holds together well over time when protected from humidity and air. In genuine manufacturing scenarios, working with crystalline powder eliminates complications from liquid carrier systems. The purity of pharmaceutical grade, especially under BP, EP, or USP standards, can mean the difference between product approval and shipment rejections in tightly regulated markets. The raw material cost often jumps with certification, but this investment lines up directly with confidence in formulation outcomes. As global sourcing expands, compliance with the proper HS code and exact documentation limits customs issues. These practical details signal just how vital it becomes to choose the correct grade, supplier, and storage practices for Azone powder.