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N-[(1R)-2-[1,1'-Biphenyl]-4-Yl-1-(Hydroxymethyl)Ethyl]Carbamic Acid 1,1-Dimethylethyl Ester BP EP USP Pharma Grade: An Examination of Properties, Structure, and Application

What is N-[(1R)-2-[1,1'-Biphenyl]-4-Yl-1-(Hydroxymethyl)Ethyl]Carbamic Acid 1,1-Dimethylethyl Ester?

This chemical, commonly known by its longer IUPAC designation, stands as a vital raw material across the pharmaceutical spectrum, appearing in many research and production settings. The substance carries the molecular formula C20H25NO3, bringing a molecular weight of about 327.42 g/mol. Years in a laboratory environment has shown me that items like this, known for their structural clarity and consistent behavior, offer stability in formulation work. Its structure contains a 1,1'-biphenyl core with a hydroxymethyl group joined to an ethyl chain and an ester moiety, which delivers unique physical and chemical stability demanded in pharmaceutical synthesis.

Physical Characteristics and Properties

This compound appears as a solid at room temperature, often presenting itself as flakes, powder, or small crystalline pearls depending on processing and storage conditions. The density hovers around 1.18 g/cm³, which falls within an expected range for materials of similar aromatic character and ester content. Some batches flow loosely, resembling loose powder, while others exhibit a more compact, crystalline appearance that suggests high purity and minimal contamination. The material’s melting point usually sits comfortably, making precise handling possible for both research and production environments. As a solid, it stores well, resists caking in dry environments, and dissolves in organic solutions suitable for further chemical manipulation.

Specification, Purity, and Standard Compliance

Suppliers who cater to the pharmaceutical world produce the BP, EP, and USP grades of this ester, aligning the product with essential global compendial standards. These standards guarantee high levels of purity; generally, purity specifications rest at 99% or above on a dry basis, ensuring it poses no risk of unwanted byproducts in formulation. Residual solvents—often a concern with aromatic carboxylic derivatives—are kept below tight thresholds, with HPLC and GC testing routinely conducted to verify the absence of hazardous trace substances. From my perspective, finding consistent quality that aligns with international standards builds trust in process scalability and validates the safety profile of finished products.

Chemical Structure and Molecular Formula

The structure of this chemical includes the biphenyl skeleton, an area often exploited for its rigid, planar properties and its ability to lend new compounds both hydrophobic and electronic features. The carbamic acid ester group, married to the biphenyl platform, boosts the molecule’s pharmaceutical utility, offering reactivity points for drug synthesis and modification. This architecture means the product is well suited for complex synthesis, both as an intermediate and, in certain settings, as a final or near-final API component. The typical molecular formula C20H25NO3 mirrors this dual nature, balancing functional group activity with overall molecular bulk.

HS Code, Material Safety, and Environmental Impact

For customs, international shipping, and trade purposes, the proper HS (Harmonized System) Code for N-[(1R)-2-[1,1'-Biphenyl]-4-Yl-1-(Hydroxymethyl)Ethyl]Carbamic Acid 1,1-Dimethylethyl Ester most frequently falls under 2933.99, which covers heterocyclic compounds with nitrogen hetero-atom(s). The presence of the biphenyl system, paired with an isopropyl carbamate group, prompts transport authorities to treat the item with due diligence. Many facilities flag this raw material as potentially hazardous or harmful if mishandled. During years working in chemical storage and compliance, I’ve seen a variety of best practices: ample ventilation, storage below 30°C, and the use of chemical-resistant gloves all rank among the measures that protect staff and maintain product integrity. Spill containment materials and correct waste disposal methods prevent contamination and minimize any chance of environmental release, satisfying both internal protocols and regulator scrutiny.

Forms: Flakes, Solid, Powder, Pearls, Liquid, and Solution

The product’s flexibility in physical form brings clear advantages across manufacturing scenarios. As a solid powder, it transitions well into solutions or suspensions for chemical processing stages. Pearl and flake formats, less dusty and easier to weigh without loss, suit both manual and automated dispensing. On rarer occasions, solubilized versions find use, particularly in advanced laboratory environments or as stock solutions for analytical work. My direct experience with all these forms has made clear that choosing the correct form can streamline workflow, boost workplace safety, and minimize waste at every touch point in the supply chain.

Handling, Hazards, and Health Considerations

Chemicals of this nature, especially those defined for BP, EP, and USP requirements, must be handled with an awareness of their potential health effects. Many institutions require Safety Data Sheets (SDS) clearly displayed and available, naming any potential inhalation, ingestion, or dermal exposure risks. Eye protection, lab coats, and fume hoods become standard elements in any workspace where this substance is measured or manipulated, since esters, by their reactive nature, may irritate sensitive tissues if contact occurs. Disposal meets both local and international hazardous waste regulations, especially where bulk processing or repeated small-volume use increases aggregate risk. Companies that take these steps see improved worker health metrics and fewer incidents.

Role as a Raw Material in Modern Pharma Production

As a raw material, this ester has shifted roles across the changing pharmaceutical landscape. Once a specialty item, it now features in the mainstream pipeline, valued for its precise stereo-chemistry and reliable functionalization during drug development. Known intermediates like these enable the production of high-profile therapeutics with rigorous reproducibility, essential for regulatory filings and global supply chains. Process chemists and manufacturing managers regularly depend on tightly specified supplies, since a single off-spec delivery can disrupt both research and revenue — a lesson I’ve learned from both planned trials and unexpected deviations. Shortages or interruptions ripple far beyond the immediate lab, affecting entire batches, project timelines, and ultimately patients awaiting critical therapies.

Moving Toward Safer, Sustainable Use

With regulatory landscapes tightening and customers demanding both transparency and safety, producers have begun sharing detailed traceability data for each batch, linking certificate analysis to source materials and production lots. Sustainable chemistry initiatives now look at solvents used in production, emissions at each stage, and post-use disposal plans, all aimed at reducing the environmental impact. Some suppliers work with clients to return empty containers or reprocess unused chemicals, lowering total hazardous load. Ensuring safe shipment — with robust secondary containment, clear labeling, and strict adherence to international protocols — protects both people and the planet, and signals a long-term approach to responsibility.

The Importance of Trust, Quality, and Ongoing Innovation

Relying on N-[(1R)-2-[1,1'-Biphenyl]-4-Yl-1-(Hydroxymethyl)Ethyl]Carbamic Acid 1,1-Dimethylethyl Ester means working with a substance at the heart of modern drug discovery and production. Its specification, consistency, and safety profile shape outcomes from the moment of delivery to the final finished product at the patient’s bedside. Chemists, procurement officers, safety managers, and regulatory specialists all look to see not only that today's batch meets published requirements, but that tomorrow’s improvements can further reduce risk, raise quality, and serve society’s need for safe and effective medicines. Reliable sourcing, transparency, and interaction with innovation partners create the foundation for lasting progress in science and human health.