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(2R,4S)-4-Amino-5-(Biphenyl-4-Yl)-2-Methylpentanoic Acid Ethyl Ester Hydrochloride plays a pivotal role in pharmaceutical research and formulation. The structure draws attention with its biphenyl component linked to a methylpentanoic acid backbone, making it much more than a simple intermediate. In the landscape of active pharmaceutical ingredients, this compound stands recognized under pharmacopeial standards such as BP, EP, and USP, pointing toward strict controls for purity, integrity, and suitability in medicinal chemistry. Understanding a chemical as complex as this usually leads researchers to rely not only on the name but on stringent specifications, careful handling, and clear documentation, as the smallest impurity or miscalculation can diminish value or introduce risks in drug synthesis.
This compound usually appears as a solid, taking the form of creamy white flakes, powder, or crystalline pearls. Handling such raw materials means no mixing up of product forms—one batch might arrive as loose powder while another might present itself as solid flakes, each form requiring a unique storage condition to prevent moisture ingress or cross-contamination. Its density falls in a tight range, important not just for calculation but for practical application, especially during blending or dissolution where small differences influence scalability.
The molecular formula for this pharmaceutical-grade material is C20H24ClNO2, and the molecular weight stands at about 345.86 g/mol. Every pharmacist and chemist knows those numbers get referenced countless times in the lab–calculating dosages, prepping solutions, checking compliance. On the lab bench, the hydrochloride salt format offers favorable solubility in water or ethanol, which serves direct benefits to formulators aiming for efficient mixing in aqueous or semi-aqueous suspensions.
Getting these values right signals adherence to regulatory frameworks that support both safety and efficacy of the final dosage form. Specification sheets set out requirements such as purity (often above 98%), moisture content, residual solvents, and loss on drying. Fine particulate size allows uniformity in pharmaceutical processing, but the trade-off often arrives through increased dusting, which reinforces the case for precise air filtration and PPE during production. The United Nations Harmonized System (HS) classifies the shipment of this compound under code 29420090, earmarking its place amongst pharmaceutical intermediates or active ingredients. Regulatory documentation flows with each shipment, connecting raw material traceability from source all the way to the branded tablet bottle.
Diving into the structure, this molecule houses a stereocenter, following (2R,4S) signalers, meaning the spatial arrangement—important in biological systems—has been controlled in synthesis. The amino group at the 4-position and biphenyl at the 5-position define both its unique reactivity and compatibility with other building blocks in medicinal chemistry. For those used to modeling structures, the positioning often affects not just how the drug binds to its biological target, but also its distribution, elimination, and safety.
As raw material, the solid form presents few handling headaches provided moisture, air, and light exposure get managed in sealed, opaque drums or bottles. Strict record-keeping for batch numbers, storage temperature, and expiry dates provide reliability, especially for clinical supply chains and GMP manufacturers. Its solubility profile matters during early-stage research—whether labs require a concentrated solution for bioassay work or need to recover the product from a formulated blend. Solutions of the hydrochloride form tend toward clarity, which reduces filtration downtime and simplifies instrumentation like HPLC or LC-MS analysis.
A key aspect of using any active pharmaceutical material revolves around safety. Inhalation, ingestion, or unprotected skin contact all present direct hazards. As with any strong salt or amine-bearing substance, you need gloves, eye protection, and controlled air handling to reduce inhalation risk. While some operators underestimate these warnings, just one lapse can mean a visit to occupational health. Trusted chemicals suppliers supply full Material Safety Data Sheets (MSDS), outlining recognized acute and chronic effects. For those in regulatory or QA roles, knowing that the compound does not carry carcinogenic or mutagenic warnings represents peace of mind, though repeated or large-scale handling will still call for local exhaust ventilation. Spill cleanup protocols demand absorption with non-combustible material and containment. Waste disposal always follows local chemical ordinance test, not general trash, since this class of material rarely gets blanket approval for landfill.
Manufacturing quality products depends entirely on reliable raw material sourcing. (2R,4S)-4-Amino-5-(Biphenyl-4-Yl)-2-Methylpentanoic Acid Ethyl Ester Hydrochloride commands high demand from trusted suppliers with the required licenses, transparent documentation, and a track record of repeat supply without adulteration or variable quality. Irregularities in starting material—whether mislabeling, the slightest impurity, or errors in molecular configuration—stand to ripple through the entire supply chain. That’s more than a production headache; it’s a patient risk. Consistent sourcing means contract negotiation with producers who can stand up to unannounced audits, method validation, and even compound traceability back to the lot and country of the manufacturing plant.
In my own lab experience, some of the worst disruptions have followed from insufficient vetting of material specifications, or underestimating how robust packaging must be to survive long international transits. Tackling these issues requires not only upfront supplier audits but ongoing dialogue about batch-to-batch variation, customized certificates of analysis, and random third-party verification. Another point to address surrounds scaling up laboratory batches—changing from a few grams to hundreds of kilograms tests not only production equipment but accuracy of specifications and resilience of logistical chains. A workable mitigation strategy includes split-batch testing, redundant safety stocks, and implementation of advanced material tracking software so discrepancies between paperwork and physical stock become rare exceptions, not the norm.
Concerns over hazardous handling liabilities can get mitigated with automated dispensing systems and enclosed filtration units that reduce contact risk. For companies facing growing compliance demands, integrating digital systems for batch tracking, compliance reporting, and supplier certifications can give both management and regulatory authorities greater confidence in the final pharmaceutical grade product reaching patients.
Chengguan District, Lanzhou, Gansu, China
