(2R,4S)-5-([1,1'-Biphenyl]-4-Yl)-4-((Tert-Butoxycarbonyl)Amino)-2-Methylpentanoic Acid belongs to the family of amino acid derivatives, drawing attention in the pharmaceutical sector for its purity and regulatory compliance. This compound appears as either a crystalline solid with shining flakes, or as an off-white to pale powder in its standard pharma grade form. Its molecular formula, C24H29NO4, underlines its complexity as a raw material primed for use in synthesis of active pharmaceutical ingredients. Density values for this substance often reach around 1.16 g/cm³, though slight variations depend on batch-specific parameters and storage conditions encountered during transit. Chemical suppliers dealing with this molecule manage distinct material forms—solid pearl, powder, or crystalline bulk—depending on each application’s requirements and scalability in manufacturing.
Structurally, the backbone comprises a methylpentanoic acid scaffolding with two chiral centers, attached to a striking 1,1’-biphenyl ring at the 5-position and protected at the 4-position by a tert-butoxycarbonyl (Boc) group on the amino moiety. The presence of two stereocenters (2R,4S) is not just a matter for academic discussion; the orientation deeply impacts reactivity and biological function whenever the compound acts as a precursor or building block in peptide or drug manufacturing. Molecular weight clocks in at 395.49 g/mol, a critical value for both inventory management and accuracy in synthesis recipes. The substance maintains stability under recommended temperature and light conditions but should always be handled and stored to minimize exposure to humidity and direct sunlight due to Boc deprotection risk or hydrolysis.
In the pharma grade environment, conforming to British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) guidelines shapes every specification sheet or certificate of analysis. Impurity profiles, residual solvent thresholds, optical purity, and melting point (generally measured between 90°C and 110°C depending on the laboratory) receive strict monitoring. Heavy metals such as lead, arsenic, and mercury fall far below regulatory cut-offs, typically analyzed down to parts per billion with ICPOES or similar instruments. Stringent checks extend to optical rotation, ensuring product isomerism stays within defined limits, thus directly affecting downstream pharmacological performance.
Customs worldwide categorize this chemical under HS Code 292249 for other amino-acids and derivatives with a heterocyclic ring structure excluded from standard listings. For companies moving bulk shipments, knowledge of proper customs code and compliance paperwork prevents costly border delays and underpins trust across supply chains. Coordinating on transport documents, ensuring the right hazard statements appear on all external and internal labels, and verifying containers meet local regulatory standards, all tie directly back to knowing the correct HS Code and product classification.
Material appears mainly as a fine crystalline substance or flake-like powder—each form balancing ease of measurement and safety in handling. Pouring or transferring uses dust-reducing techniques for worker protection. Strict separation from acids and oxidizing agents ensures chemical stability throughout storage and handling. For those in production, gloves and lab coats remain standard; the potential to cause irritation or pose mild toxic hazards means users never ignore safety recommendations. Any accidental contact with mucous membranes or ingestion prompts emergency protocols, immediate medical consultation, and accurate reporting for post-incident review.
Material safety data sheets (MSDS) flag this compound primarily as an irritant, with low-level toxicity at relevant handling concentrations but warranting respect for potential harmful effects. Inhalation of dust, skin contact, or accidental ingestion should all be avoided—routes of exposure flagged by decades of experience in chemical safety and regulatory compliance. Adequate ventilation, full PPE, and reliable containment protocols minimize risk and form the baseline expectation in labs, pilot plants, or contract manufacturing organizations dealing with pharma grade amino acid derivatives. Fire hazards remain minimal as the substance rarely ignites at below-standard environmental conditions, but secondary hazards—like nitrogen oxides or carbon monoxide generation during combustion—always feature in risk assessments, so preparedness remains high.
Working in fine chemical supply management, I see how upstream quality or inconsistency impacts the reliability of a pharmaceutical process. This compound’s consistent bulk morphology, reliable solubility (commonly soluble in methanol, ethanol, and organic solvents, only slightly dispersible in water) and trace metal content all drive the efficiency of peptide coupling or subsequent derivatization steps in the pipeline. Sophisticated analytical routines, such as HPLC purity profiles and NMR verification, underpin every shipment, giving downstream manufacturers confidence in their documentation and avoiding costly batch recalls. As raw material stock, its deployment not only hinges on regulatory and physical parameters, but also on the trust built through years of dependable supply and verifiable purity.