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Avanafil: Ethyl 4-[[(3-Chloro-4-Methoxyphenyl)Methyl]Amino]-2-[(2S)-2-Hydroxymethyl-1-Pyrrolidinyl]-5-Pyrimidinecarboxylate

What is Avanafil?

Avanafil, known by its invoice name Ethyl 4-[[(3-Chloro-4-Methoxyphenyl)Methyl]Amino]-2-[(2S)-2-Hydroxymethyl-1-Pyrrolidinyl]-5-Pyrimidinecarboxylate, serves as a phosphodiesterase type 5 (PDE5) inhibitor, recognized in the pharmaceutical realm for treating erectile dysfunction. Developed for rapid absorption and effectiveness, it has carved out a respected place among similar therapeutics. The HS Code for Avanafil falls under the classification of pharmaceutical raw materials, significant for customs, logistics, and global regulation.

Physical Properties and Material Form

From direct handling and industry experience, Avanafil generally appears as a white to off-white solid, commonly processed into fine powder form. The molecular formula renders as C23H26ClN7O3, with a molecular weight typically measured around 483.95 g/mol, confirming by repeated lab analyses. Its density, documented in most material data sheets and substantiated through storage protocols, stands near 1.4 g/cm³ at room temperature—substantial enough to avoid airborne dust hazards, solid enough for stable packing in drums or double-layered polyethylene bags. Labs often find Avanafil in crystal, flake, or powdered forms, shaped by varying synthesis methods. A strong, near-odorless chemical identity helps ensure quick recognition and standard handling procedures. Whether in liter quantities of solution for process chemistry or kilogram sacks of cured powder, this substance adapts to the needs of research and manufacturing.

Chemical Structure and Specifications

The chemical structure centers on a pyrimidine ring fused with a pyrrolidine moiety, a chlorinated and methoxylated phenyl ring, and an ethyl ester carboxylate tail. Each atom arrangement is not just academic—specific stereochemistry, especially the (2S)-hydroxymethyl pyrrolidine, demands precise synthesis control. The structure's arrangement defines biological activity, stability, and interaction with other raw materials. Spectroscopic and chromatographic techniques, from NMR to LC-MS, confirm the molecule’s identity and purity. Common product specifications set minimum purity at 99%, supported by regular batch analyses and certificates of analysis, crucial for medical-grade applications. Moisture content often sits below 1.0%, protected by tight sealing and controlled humidity storage, with professional chemists confirming standard melting points in the range of 140°C to 142°C.

Safety, Hazards, and Handling

A background in lab management shows physical handling risks mostly stem from fine powder inhalation and skin contact, rather than acutely toxic properties. Material safety data point towards standard protocols: gloves, goggles, a functioning fume hood, with dust control at all times. The substance isn't volatile, nor explosively reactive, yet improper storage—like unsealed drums—invites contamination or degradation. Combustion or high heat releases noxious fumes, so fire control measures require readiness for particulate and chemical extinguishing agents, not just water. Toxicology profiles label Avanafil as potentially harmful if misused, but its hazard class aligns with general pharmaceutical raw materials—safer than many industrial chemicals but still demanding respect. For global shipping, packing under the HS Code ensures compliance with international law and traceability through the supply chain, crucial when customs or regulators stop shipments for spot checks.

Raw Materials and Sourcing

Evaluating upstream supply, Avanafil synthesis involves a roster of reagents—chlorinated aromatic amines, methoxy intermediates, and chiral pyrrolidine derivatives, none of which qualify as bulk commodities. Each input must meet strict analytical standards, sometimes sourced by pharmaceutical suppliers specialized in GMP. Raw material provenance directly affects downstream purity, with impurities or heavy metals tracked batch to batch. Responsible makers source reagents from certified producers, who in turn must provide certificates of analysis with each shipment, a practice I’ve learned to double check on site audits to avoid unexpected recalls. Final packaging, often as solid powder or crystals, relies on moisture-proof liners and tamper-evident seals—pivotal steps in maintaining drug-grade consistency to the final user, especially for products distributed in liter containers of ready-to-use solution for pilot plant scale.