Chengguan District, Lanzhou, Gansu, China sales01@liwei-chem.com 1557459043@qq.com
Follow us:



Ethyl 2-((Ethoxycarbonyl)Amino)-4-Methyl-5-(4-Nitrophenyl)Thiophene-3-Carboxylate BP EP USP Pharma Grade

What is Ethyl 2-((Ethoxycarbonyl)Amino)-4-Methyl-5-(4-Nitrophenyl)Thiophene-3-Carboxylate?

Ethyl 2-((Ethoxycarbonyl)Amino)-4-Methyl-5-(4-Nitrophenyl)Thiophene-3-Carboxylate shows up in the pharmaceutical world as a finely engineered raw material following strict BP, EP, and USP grade standards. This compound slots into chemical processes where purity cannot take a back seat, and each detail in its structure plays a direct role in its performance. Sometimes, the full name comes across like a challenge, but breaking it down shows roots in thiophene chemistry, the backbone supporting plenty of modern drug molecules. Each segment in the name points to a particular group: the ethoxycarbonylamino tail, the 4-methyl cluster, and the 4-nitrophenyl branch all carry weight, determining solubility, reactivity, and pharmaceutical compatibility. During my benchwork years, handling pharma-grade intermediates meant dealing with specs like these—fine powders, sharp melting points, and rigid batch-to-batch consistency.

Physical Properties and Structure

Looking at the molecule, the arrangement tells its own story. The thiophene ring, connected at three and five positions to a carboxylate and nitrophenyl arm respectively, holds the skeleton together. Peering at the yellow flakes or pale crystalline powder, you notice density figures generally near 1.32 g/cm³, often measured at standard lab temperature. Solid at room conditions, this material pours easily in lab trays, neither sticky nor liable to agglomerate under casual handling, which makes precise dosing manageable. Crystallinity helps during quantification, a lesson I learned after losing a weekend fighting with amorphous chunks during a scale-up run. Its solubility leans toward polar aprotic solvents, so DMF, DMSO, and ethyl acetate tackle dissolving tasks. Water solubility sticks low, reflecting the non-polar portions and bulky aromatic side. A clean, nearly white to yellowish powder means trace impurities stay out of sight, but that does not replace lab confirmation—any speck out of place hints at failure in earlier purification steps.

Specifications and Quality

Working under BP, EP, or USP pharma grades, this compound runs through a battery of specifications. Assay often targets above 99%, with allowed residues nudging no more than a fraction of a percent for related substances. Loss on drying sits underneath 0.5%, and heavy metal screening looks for even smaller traces. Maximum tolerated levels for chlorides, sulfates, and iron can add up to regulatory hurdles, especially since customers (rightly) demand batch certificates with every shipment. My memory calls up days spent pouring over COAs, making sure spectral purity lined up with expectations. Morphology—flakes, powder, or tiny crystals—links straight to intended use; pharma manufacturers might call for specific particle sizes, and bulk density figures (say 0.40-0.60 g/cm³, depending on grain shape) fine-tune handling and transport. Standard specification sheets detail melting point, sometimes in the range of 102°C to 110°C. For every kilogram, suppliers trace lot numbers down to the finest granule, with stability data locked away for audits.

Chemical Properties and Formula

Molecular formula C16H16N2O6S sets the elemental backdrop: sixteen carbons, sixteen hydrogens, two nitrogens, six oxygens, with one sulfur holding the thiophene ring together. A weight topping 364.37 g/mol lines up with how much cargo factors into bulk purchases. That nitro group, sitting at the para position on the phenyl ring, pulls on electron density, so careful mixing with strong nucleophiles or bases needs attention. Anyone in process chemistry learns the hard way that handling nitroaromatics brings its own risks—potential for dust, a touch of toxicity, demand for chemical fume hoods, and strict PPE rules on the factory floor. The ethoxycarbonyl group (COOC2H5) at position two plays a game with reactivity, providing a handle for downstream functionalization. This is not the kind of material you toss into any old flask. Every reaction step demands attention to stability, compatibility, and byproduct formation.

HS Code and Global Trade Considerations

For international movement, HS Code 29349990 often captures compounds of this structure: heterocyclic compounds with nitrogen heteroatom(s) only, not elsewhere specified. This code matters, not just for taxes or tariffs, but for regulatory oversight. Shipping documents need clear labeling, batch traceability, and all the right declarations for customs and border safety. Years of shipping chemicals taught me the challenge of mismatched codes, which can mean paperwork nightmares or, worse, impounded batches and delivery delays. Pharma manufacturers must lean into these standards if they intend to play on global fields. Out-of-date documentation or missing information leads to seized barrels and rejected contracts.

Material Forms: Flakes, Powder, Pearls, and More

In the supply chain, Ethyl 2-((Ethoxycarbonyl)Amino)-4-Methyl-5-(4-Nitrophenyl)Thiophene-3-Carboxylate comes as powder, small flakes, rarely as crystalline pearls. Each form carries handling quirks. Powder sticks to spatulas and gloves, requiring antistatic setups or anti-caking agents (though only those allowed in pharma manufacturing). Flakes pour better and resist clumping under ambient humidity, cutting down on residue loss. Bulk users sometimes request custom particle size, shaped by final application—tableting, compounding, or blending into further reactions. Bulk storage needs dry, airtight containers. A stray drop of moisture brings clumping or worst-case, hydrolysis of the ester, robbing the product of utility.

Safety, Hazards, and Handling—A Real-World Perspective

This compound’s nitrophenyl and thiophene parts demand layers of caution. Safety Data Sheets outline the hazards: harmful by ingestion or contact, irritant to skin and eyes, with risks of sensitization on prolonged exposure. Inhalation of fine dust can bring headaches or allergic reaction; with this in mind, working professionals rely on proper goggles, gloves, dust masks, and ventilated enclosures. Storage stays away from sources of heat or ignition. I remember the strict routines put in place after one colleague’s encounter with nitro-compound dermatitis—those lessons stay with you. Bottles and drums must stay tightly sealed, away from acids, oxidizers, or bases that trigger decomposition. Training becomes crucial; every new material handling training reminds workers and managers of storage, disposal, and emergency procedures. Emergency eyewash stations and spill kits stand ready, never far from workbenches in any responsible lab or manufacturing space.

Raw Material Application and Industry Role

Ethyl 2-((Ethoxycarbonyl)Amino)-4-Methyl-5-(4-Nitrophenyl)Thiophene-3-Carboxylate operates as a raw material in pharma synthesis, giving medicinal chemists and process engineers a tagged intermediate for developing advanced therapeutic molecules. It finds its groove in producing segment-specific drug intermediates, especially those targeting unmet medical needs in the anti-inflammatory, oncology, or anti-infective spaces. Each time I’ve worked with a similar intermediate, the process required an unwavering focus: accurate weighing, double-checked batch records, meticulous traceability from raw material through intermediate and into the final active pharmaceutical ingredient. Production teams build protocols around this compound’s quirks: moisture control, temperature management, and left-to-right record keeping for regulatory inspection. Any deviation or contamination at this step risks failing downstream synthesis and losing tens of thousands in wasted reagents.

Pursuing Safer and Sustainable Practice

Chemistry never runs in a vacuum. The drive for greener, safer production nudges manufacturers toward alternative synthetic routes, closed-loop systems, and solvent recovery units. Nitrophenyl derivatives raise questions about environmental impact—byproducts must be captured, tracked, and treated before any waste leaves the plant. My experience at a pilot plant brought home the cost of unsafe disposal, both in environmental fines and reputational damage. More labs champion continuous monitoring, in-process controls, and closed transfer systems to cut worker exposure. Strong company culture around safety turns into lower incident rates and higher staff retention. Investing in robust documentation, transparent ingredient sourcing, and sustainable packaging earns long-term supplier trust, smoothing out the choppy seas of global supply chains. GMP-level auditing, third-party testing, and robust recall systems shore up confidence among regulators and final customers.