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Much has changed in chemical manufacturing in the last forty years. Early explorations into cyclopropanamine derivatives came from basic curiosity about strained rings and their unique reactivity in organic synthesis. As pharmaceutical research shifted focus to smaller, more rugged molecules capable of binding tightly to biological targets, chemists took a closer look at cyclopropane cores, especially those bearing electron-deficient aromatic groups. In this landscape, (1R,2S)-2-(3,4-difluorophenyl)cyclopropanamine hydrochloride rose in prominence. The synthesis of enantiomerically pure amines, once a feat reserved for advanced labs, now forms the cornerstone of modern custom synthesis services, driven by relentless improvements in chiral catalysts and resolution methods. Pharmaceutical compendia like BP, EP, and USP list this compound, pointing to its dependable utility in regulated sectors, and fueling a steady demand from international research communities.
At its core, (1R,2S)-2-(3,4-difluorophenyl)cyclopropanamine hydrochloride consists of a cyclopropane ring fused strategically with a difluorophenyl group at the 2-position, offering a clever balance between chemical stability and biological activity. The hydrochloride salt finds favor in pharmaceutical research because it resists atmospheric moisture and dissolves well in both water and common polar aprotic solvents, a property not shared by all amine derivatives. The precise stereochemistry—(1R,2S)—plays a determinative role. Chiral molecules behave differently in living systems, affecting everything from bedrock receptor affinity to metabolic half-life. Pure, well-labeled product ensures that what researchers study in the lab remains consistent with what regulators demand and clinicians request.
This compound typically forms a white to off-white crystalline powder, odorless to the average lab technician, packing a noticeable density that makes weighing easy on most balances. With a defined melting point often observed within a 10°C range—specific values hinge on salt content and drying technique—quality control teams can spot deviations linked to impurity or incorrect isomer ratios. Solubility extends comfortably into water, methanol, ethanol, and DMSO. Chemically, the cyclopropane ring shrugs off mild acids or bases, catering to diverse reaction conditions. At the same time, the fluoro substituents on the phenyl ring provide metabolic resilience. Fluorine atoms shield the aromatic system against enzymatic oxidation, creating opportunity for longer-acting medicines.
Manufacturers supply this amine hydrochloride to pharma standards under the guidance of BP, EP, or USP monographs. Labels don’t just list the common name—they detail stereo-configuration, batch number, assay value (often NLT 98%), residual solvent limits, water content by Karl Fischer titration, and heavy metal test results. Each technical data sheet spells out all the physical parameters alongside gradient methods for impurity profiling by HPLC, spectral identity by NMR and IR, and, crucially, chiral purity by chiral HPLC or capillary electrophoresis. Reputable suppliers provide certificates of analysis with every lot, so that every downstream lab or formulation house knows exactly what reaches their bench. These documents serve as legal guarantees for GMP, making sourcing as transparent as possible.
Crafting such a molecule rarely proves straightforward in bulk. The usual synthetic route starts with the difluorobenzene precursor, sets the cyclopropanation using a Simmons–Smith reaction or a diazomethane route, then introduces the amino functionality with selective hydrogenation or an azide reduction pathway. Each step demands close monitoring, as yields and diastereoselectivity turn on fine-tuned temperature, solvent choice, and the order of reagent addition. Analytical chemists always favor precise NMR and GC-MS to affirm structure and purity before proceeding to salt formation. Crystallization from alcohols or ether ensures a material that packs well, stays stable, and is easy to handle during formulation. None of this happens by accident; seasoned process chemists refine every batch based on in-process controls and analytical data, with robust process safety guidelines shaping every scale-up.
This amine sits at an interesting crossroads for further elaboration. Reductive amination, N-acylation, and urea formation work without skipping a beat, since the primary amine stands eager for modification. Electrophilic aromatic substitution on the fluoro-phenyl moiety proceeds sluggishly, as those fluorines stubbornly block common attacks. On the flip side, the ring system resists most radical-mediated fragmentation—this opens the door for late-stage diversification, where medicinal chemists chase new analogs without dismantling the scaffold. For anyone exploring SAR (structure-activity relationships) across CNS or cardiovascular indications, the core can handle a fair bit of molecular tinkering.
Researchers and regulatory submissions refer to this molecule by several names, adding to the confusion unless documentation stays strict. Typical aliases include (1R,2S)-2-(3,4-Difluorophenyl)cyclopropan-1-amine hydrochloride, Difluorophenyl cyclopropanamine HCl, DFPCPA HCl, and various manufacturer trade names. Proper usage in method validation, regulatory filings, and pharmacopoeia references hinges on aligning these synonyms with unique CAS and catalogue numbers.
Safety isn’t just a checkbox in modern laboratories. Anyone handling amine hydrochlorides must guard against inhalation and skin contact, since some cyclopropane amines can trigger sensitization or respiratory irritation. MSDS (Material Safety Data Sheet) guidance sets limits for storage, points to compatible PPE, and spells out spill control procedures. Companies invest heavily in closed transfer systems, localized ventilation, and LEV (local exhaust ventilation) to keep personnel protected. Waste disposal protocols comply strictly with EPA and ECHA rules, with regular training to reinforce best practices. Stability studies—accelerated and real-time—guide recommendations around shelf-life and storage conditions, reducing the risk of compound degradation before use.
Medicinal chemistry teams prize this compound as both a lead-like fragment and a late-stage intermediate. The cyclopropane motif appears regularly in anti-viral, CNS-active, and cardiovascular agents, with the difluorophenyl group lending selectivity at key biological receptors. Not every compound turns into a blockbuster, but for every hundred molecules screened, a handful show promise in in vitro or in vivo efficacy. Beyond drug discovery, analytical labs use this standard for validating metabolic pathways, calibrating LC-MS equipment, and preparing reference standards for bioanalytical studies. Fine chemical vendors and CROs build small custom libraries for client-specific screening programs, further growing the base of scientific knowledge around this versatile scaffold.
The pace of innovation in the pharmaceutical sector rests heavily on the availability of well-characterized building blocks like this one. Years spent working in R&D only increased my appreciation for solid data and reliable supply chains. Custom synthesis groups continually experiment with greener, more efficient synthetic protocols for these chiral amines. Technologies like continuous-flow reactors, asymmetric hydrogenations, and high-throughput parallel synthesis have changed timelines and the scale at which chiral intermediates come to market. Collaborative research projects, especially the push toward AI-guided compound design, further expand the universe of potential analogs derived from the core amine. What matters most is sharing detailed analytical data, stability information, and route-of-synthesis notes, not just to speed discovery, but to ensure reproducibility and fidelity in both academic and commercial work.
No one stakes future investment on a molecule without understanding its safety profile. Rigorous studies draw on standardized protocols—acute oral, dermal, and inhalation toxicity studies in rodents, genotoxicity assays, and repeat-dose toxicity on cellular and tissue models. The difluorophenyl substitution often helps reduce oxidative metabolism, translating to lower reactive metabolite formation. Early reports from screening assays indicate that at well-characterized doses, off-target toxicity remains manageable, especially once formulators buffer the hydrochloride salt in development batches. Nevertheless, the data remains routinely updated as more in vivo and clinical information emerges, especially since small stereochemical changes can tip the safety balance in unexpected ways.
Future work aims to push boundaries in several directions: more sustainable synthesis routes, higher selectivity in asymmetric catalysis, and improved safety data packages to inform both regulators and the public. As drug targets grow more complex, chemists reach for structurally robust and bioactive scaffolds. This amine fits the bill—a fact not lost on biotech start-ups and multinationals alike. Better collaboration between process chemistry, analytics, regulatory teams, and clinicians will keep unlocking new therapeutic uses, especially across neurodegenerative and psychiatric indications where small rings and halogenated aromatics continue to play outsized roles. Open data sharing and direct researcher feedback will continue to shape how this molecule is made, tested, and ultimately applied in medicine and beyond.
Every time a pharmaceutical grade compound enters a lab or manufacturing plant, purity isn’t just a line on a certificate—it’s the backbone of safety and trust. I’ve seen research ground to a halt because a single impurity appeared in the sample analysis. For (1R,2S)-2-(3,4-Difluorophenyl)cyclopropanamine hydrochloride, purity sheds light on identity, patient safety, and the integrity of finished medicines. Glitches like minor contaminants or unexpected byproducts aren’t minor for pharmaceutical teams; they’re reasons for costly recalls or painful regulatory delays.
Pharmacopeias set the bar. The BP, EP, and USP each outline what “pharma grade” means, carving out not just minimum purity percentages but also spelling out thresholds for related substances, water content, and inorganic impurities. For this cyclopropanamine hydrochloride, pharmaceutical reference standards demand that purity exceeds 99% (HPLC, area normalization), which means that raw material suppliers and QC labs align their procedures with reference standards established by these pharmacopeias.
Any related substances, including structural analogs or process byproducts, usually cannot surpass the 0.1% to 0.15% mark each, and the sum of all impurities often has to remain less than 1%. This is more than regulatory paperwork. I’ve listened to scientists talk about how even trace contamination can trip analytical methods downstream, sending teams back to the drawing board.
Drug substance guidelines under BP, EP, and USP tighten restrictions on residual solvents. Each solvent has its own limits, assigned based on its toxicity and likelihood to stay in the product. Even if the compound’s synthesis uses a benign solvent, like ethanol, there’s zero lenience—a limit is a limit, often less than a few hundred ppm. Inorganic impurities such as chlorides, sulphates, or heavy metals get monitored, usually capped at micro-gram levels. Seeing a batch fail on metals testing often points to careless water or reagent handling in the process.
Clear purity criteria help manufacturers avoid expensive rework and ensure patient safety. Over the years, I’ve seen teams invest in better purification methods—crystallization tweaks, higher-performance chromatography, solvent recycling all make a difference. Many rely on robust, validated analytical methods, not just the basics like HPLC but NMR and LC-MS whenever there’s a need to confidently rule out unknown peaks.
Education matters in this space. Without continuous training in analytical science or data interpretation, even experienced teams can misjudge chromatogram spikes and risk releasing subpar product. Encouraging younger scientists to challenge unexpected results has led to breakthroughs, revealing new process impurities that weren’t listed in reference monographs.
Clean, unambiguous standards keep the pharmaceutical supply chain honest. Practicing robust risk assessment in raw material sourcing saves time, money, and protects patients. Each specification for this amine hydrochloride isn’t just a bureaucratic hoop—it stands for the real-world commitment to quality that modern pharma manufacturing demands.
Working in the pharmaceutical field, I often run into this question: is a product compliant with BP, EP, and USP standards? To some, it may sound basic or just another tick on a checklist, but it goes far deeper. These standards, set by the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP), represent layered safety, science, and trust at play. They aren’t just stamps on labels—each represents a batch of rules and tests drawn from decades of research, collaboration, and hard-learned lessons from past mistakes.
Pharmacopeias draw the line between products you can trust and those you simply shouldn’t. With a compliant product, you’re looking at controlled contaminants, proven assays, and directions for handling. I’ve worked on projects where failing just one parameter—like heavy metals—meant the entire batch had to be destroyed to keep patients safe. Each pharmacopeia sets limits, often similar but not always the same, and ignoring even a small difference can ruin a launch or, worse, put lives at risk.
Earlier in my career, our team handled a supply for both EU and US markets. One batch contained slightly higher levels of a residual solvent—not dangerous by EP standards, but above USP’s threshold. That one missed detail held back shipments for weeks, caused thousands of dollars in losses, and forced the team into months of regulatory back-and-forth. Problems like this feel more than technical; they hit morale, trust, and a company’s reputation.
Global markets aren't forgiving when shortcuts happen. Clients demand both consistency and transparency. If a product claims compliance, regulatory agencies in each region won’t hesitate to audit. In some cases, non-compliance can trigger recalls, public warnings, or fines that drag a small company under. Those standards serve as guardrails, stopping unsafe drugs before they even reach a pharmacy shelf.
For anyone manufacturing or sourcing pharmaceutical products, getting compliance means deep work on the ground. This starts with validated methods, regular internal audits, and detailed documentation of every batch’s test results. Real compliance shows up in paper trails—results for identity, purity, and microbiological limits—audited both internally and by third parties. Relying on outdated certificates, or testing just the minimum, isn’t enough.
Some manufacturers put in the extra work and invest in robust quality systems. I’ve seen companies set up their own in-house testing labs, partner with independent certifiers, and offer clients access to all test protocols and results. These extra steps often make the difference when regulators show up or clients ask tough questions. Customers trust brands that share not just end results, but also the methods used to get there.
No single set of standards covers all the questions. Pharmaceutical companies investing in quality usually cross-check BP, EP, and USP in the earliest phases of product development—not just at the marketing stage. Staff training, updated standard operating procedures, and third-party audits go far in closing compliance gaps.
In practice, open dialogue with suppliers helps uncover risks before they become disasters. Every person on the quality team should feel empowered to flag potential issues without fear. Creating a culture of continuous improvement and shared responsibility shapes long-term trust in the product, the company, and, ultimately, the medicines that patients rely on. Pharmacopeial compliance isn’t simply about ticking boxes. It’s about building safety, day in and day out, into every step of the process.
Anyone working with chemical compounds knows controlled storage is more than a box-ticking exercise. Small mistakes snowball. A few degrees off target and you risk losing purity or even creating dangerous breakdowns. Experience shows temperature swings open the door to contamination and unexpected reactions. Cold storage does not guarantee safety if humidity seeps in. Moisture, often overlooked, activates slow changes—especially for hygroscopic or hydrolyzable substances—sometimes long before the product smells or looks wrong.
A real example comes to mind from grad school. We rushed a synthesis, left the product in a cabinet for a weekend, thinking the cap sealed tight. Monday greeted us with sludgy disappointment. Open contact with air robbed our work of potency. Some may say a desiccator is only necessary for highly reactive materials, but such thinking underestimates how sneaky oxygen and moisture can be. Research backs this up: according to the American Chemical Society, about 20% of lab mishaps relate to improper storage or unmonitored chemical aging.
Labels with “best before” imply certainty, but shelf life’s more dynamic than dates suggest. Exposure starts a clock before shipments even reach the lab. Even small temperature jumps during transit slowly trim usable life. Keeping logs pays off; noticing odors or color changes early means fewer wasted experiments. It's smart to ask vendors about batch-specific shelf life, not just catalog entries, since organic batches—from vitamin powders to pharmaceutical intermediates—can vary depending on synthesis route or storage additives.
Data on stability helps, but anecdotal evidence matters too. In pharmaceutical work, a compound on the shelf for years sometimes passes all identification tests, yet fails actual biological assays. Companies such as Sigma-Aldrich or Merck recommend storing organics in amber glass to guard against light degradation, and for some chemicals, even “room temperature” is too warm, especially in tropical labs. Some friends in developing countries found portable fridges or air-tight containers packed with silica gel made a night-and-day difference in product longevity and batch repeatability.
Start with smart labeling. Notes about opening dates, transfer events, and observed changes beat generic batch notes every time. Organize products not by alphabet, but by storage requirements—keep moisture-lovers together, acids away from bases, and oxidizers as far as possible from organics. Even in tight spaces, separating volatile from non-volatile substances proves wise.
Investing in proper containers pays off. Amber bottles for light-sensitive materials cost a bit more but save hours lost repeating failed experiments. Add a few silica packets to organics, and rotate stock based on usage patterns, not calendar months. For temperature-sensitive materials, small temperature loggers can spot trends in heat spikes that go unnoticed during weekends or power outages.
For critical compounds, document everything. Routine inspections with a checklist protect research—and lab staff—from surprises. If costs must be cut, limit it to quantities, not storage safeguards. Skimping on conditions might leave users with expensive dust instead of working science.
Climate, local infrastructure, and even lab layout change how quickly compounds deteriorate. Labs far from supply chains struggle more with storage, so buffer stock and periodic quality checks become essential. Human habits play a role too—teammates forgetting to re-cap or place vials in the right fridge can erase months of work. A culture of daily checks and open communication proves just as important as the fanciest storage tech.
Anyone who asks, “Can you provide the certificate of analysis and batch-specific documentation?” isn’t just being bureaucratic. They’re asking for proof. You’d be surprised how many times products on paper look great and then fall short in the real world. Years ago, I worked with a supplier who swore every shipment was to spec. After a customer flagged odd results, we requested the COA for that specific batch. The numbers didn’t match up. That’s not just a paperwork error—it’s a foundation for potential failures down the supply chain.
Certificates of analysis aren’t some regulatory hoop to jump through. They show what a supplier actually did—not just what they intended. For manufacturers, these documents mean you’re not setting your business or your clients up for nasty surprises. In food, chemicals, or pharmaceuticals, the stakes go way beyond brand reputation. The wrong numbers can mean contaminated food on shelves, medicine that doesn’t work, or even unsafe consumer products. The FDA and global regulatory bodies know this. That’s why traceability comes into play—batch numbers, test results, and specific analytical data form proof that someone checked, double-checked, and put their name on it.
A useful COA lays out exactly which batch got tested, clear identification, test methods, dates, reference standards, and a responsible signature. It can’t be a generic PDF; the document needs to tie directly back to the container that reaches the user. If you see a COA that has the supplier’s company name but no lot or batch number, or the same boilerplate test results for every delivery, something’s off.
People ask for batch documentation because they’ve seen things go wrong, and sometimes the cost is more than financial. A well-maintained supply chain must show that today’s batch meets the same bar as yesterday’s. Quality managers lose sleep over “just trust us” guarantees. With legal liability, customer safety, and brand trust on the line, relying on a vague promise isn’t enough—customers need proof.
Firms that try to hide or delay batch documentation eventually run into trouble. Open documentation protects producers and buyers alike. Technology can streamline this process, from digital batch tracking to automated test uploads. Upgrading IT systems to interface with regulatory databases pays off by catching small mistakes before they become lawsuits or recalls.
Real transparency isn’t just showing a document on demand — it’s creating an environment where documentation follows the product at every step. Leadership teams should treat batch documentation as a daily essential, not an afterthought for audits. With consumer expectations rising and testing technologies improving, it pays to go beyond the bare minimum. Anyone unwilling to share a proper certificate or relevant report is asking for trouble, one missing document at a time.
Packages shape every buying decision I’ve made in bulk—sometimes the product is right, but the packaging throws a wrench in things. You see it in warehouses and even at the smallest shop. The type of container, its weight, and how easy it is to move can make or break a deal. Bulk buyers care about the price per unit, but also how long it takes for the order to hit the dock. Someone filling a factory doesn’t want to move around fifty tiny boxes if one drum will do the trick. Meanwhile, smaller operations cringe at waste or extra paperwork when all they need is a manageable sack.
Boxed goods, sacks, drums, and totes all circle around the same challenges: cost, safety during shipping, and how much shelf space they chew up. Boxes range from five kilograms up to twenty-five kilograms, common in both food and chemical supply. Drums step in at the two-hundred-liter or fifty-five-gallon mark, part of daily routine for manufacturers and food processors. Sometimes, flexible intermediate bulk containers (FIBCs, “super sacks”) show up for materials leaving at one metric ton or more.
People I’ve worked with in agriculture lean toward sacks because they can carry them by hand or run them through a filling line. Food service buyers usually stick with boxes or plastic tubs in portioned sizes to avoid spoilage and mess. Bigger pack sizes cut down on labor, with one container feeding a whole line, but there’s always a limit. Spill one-ton sack and you’re looking at a costly cleanup, not to mention safety checks.
Ordering something in bulk often comes with this big question: how long is the wait? My experience with suppliers taught me that lead time depends on the size of the order, special labeling, and the distance between a warehouse and the customer’s door. Local stock shaves days off the wait; products coming from another country might bring a month-long delay, even more if customs decides to hold things up.
For in-stock goods in common sizes, lead time can fall between two and seven days. If somebody needs five pallets of a less common size or a special liner inside the bag, the supplier might quote two or even four weeks. Importers shipping raw material in containers often face extra days lost in transit, even without supply chain hiccups.
Everyone loves a promise of “fast delivery.” That promise sometimes crumbles during busy seasons, storms, or labor strikes. Last year, ports around the world slowed down due to staff shortages and ships stacked up at anchor. Grain producers told me they waited for packaging material that usually arrived in days, but delays stretched past a month—leaving them with nowhere to put harvested crops.
Some companies buffer against surprises by keeping more packaging in inventory, but that uses up capital and space. Good communication with suppliers keeps everyone realistic about what’s possible; emergency shipments can happen, but they carry a heavy price.
Matching the right pack size to storage, usage rate, and equipment seems obvious but gets overlooked. Checking supplier reliability, shipment tracking, and understanding both the cost and benefit of small versus large pack sizes makes a difference. Over a decade in logistics taught me that even the smoothest plan can hit a snag, so building in some flexibility—ordering a little earlier, considering a different pack size or source—pays off.
Transparency, a trusted supplier network, and a real understanding of your own consumption keep surprises—and extra costs—to a minimum.
| Identifiers | |
| ChemSpider | 15760764 |
| RTECS number | VX8223000 |
Chengguan District, Lanzhou, Gansu, China
