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2-((3Ar,4S,6R,6As)-6-Amino-2,2-Dimethyltetrahydro-3Ah-Cyclopenta[D][1,3]Dioxol-4-Yloxy)Ethanol L-Tartaric Acid: An In-Depth Commentary

Historical Development

Chemistry hasn’t always followed a straight line, and molecules like 2-((3Ar,4S,6R,6As)-6-amino-2,2-dimethyltetrahydro-3Ah-cyclopenta[d][1,3]dioxol-4-yloxy)ethanol L-tartaric acid reflect such hard-earned progress. Pharmaceutical labs churned through the late 1900s and early 2000s in search of chiral intermediates and building blocks needing precise stereochemistry. Early synthesis routes involved laborious separation of racemates and costly purification, but pressure for cleaner drugs and better yields shaped the work. The fine-tuned stereochemistry in this compound benefited from better asymmetric synthesis, braver catalysts, and engineers pushing solid-liquid separation further. You can see big leaps in purity standards after regulatory shake-ups, especially as pharmacopeias like BP, EP, and USP tightened up what they’d allow from suppliers. Open access literature and shared patents helped new entrants jump in, turning what needed multi-kilo pilot runs into an almost routine production job.

Product Overview

This molecule sounds complex on paper, yet its primary value comes from its interplay of a cyclopentadioxole ring, a short flexible sidechain, and well-controlled chirality. In pharma circles, it’s considered part of that group of chiral auxiliaries and resolving agents—you’ll find it listed as a frequently used intermediate or salt former for active pharmaceutical ingredients where controls over enantiopurity shape the performance of the drug. Not many molecules check the right boxes for pairing with L-tartaric acid in a pharma grade, but this one slots in nicely where hydrogen bonding and precise orientation matter, from crystallization processes to final tablet production. Looking at product catalogs, you’ll find it in tightly sealed HDPE drums, accompanied by a stack of analytical data and batch release specs confirming identity, purity, and moisture.

Physical & Chemical Properties

A proper look at this compound underpins its use on the warehouse floor. White to off-white crystalline powder, low-to-moderate solubility in water, most solvents used in pharmaceutical manufacturing don’t break down the core structure easily. Melting point huddles between 180°C to 190°C—giving it the thermal stability needed for controlled processing and shipping. It carries an amino group, making it slightly basic, yet the tartaric acid keeps pH shifts moderate in most reactions, useful in handling notoriously finicky active ingredients. Chemists working on multi-step synthesis focus on its resistance to hydrolysis across a range of pH values, which removes a headache from work-up steps. Optical activity measurements confirm the stereochemistry, and IR/NMR spectra serve as routine proof against any slip in synthesis or handling.

Technical Specifications & Labeling

Buyers accustomed to BP, EP, USP labels know the deal—identity confirmation with chiral HPLC, residual solvent analysis to parts-per-million, heavy metal specifications below 10 ppm, and a microbial count that barely tips the scale. Labels won’t just read the compound’s chemical name; they’ll have code numbers, manufacturer batch data, production date, and shelf life. Regulatory teams watch for hazardous labeling such as GHS/CLP pictograms confirming the correct storage and transport class. Every drum carries documentation in the form of a Certificate of Analysis, linking each lot with its test results, which field audits regularly inspect during regulatory reviews. Pharmaceutical buyers won’t even cut open a drum without confirming the attached paperwork meets both local registration and import inspection standards.

Preparation Method

My own trek through synthetic chemistry taught respect for functional group tolerance and the pain points of scale-up. Making this molecule at a kilo scale involves a cyclization reaction building a cyclopenta[d][1,3]dioxole scaffold, followed by regio- and stereoselective amination. Each stereocenter builds stack by step—chemoselective protection, selective reductions, and occasionally an enzymatic touch for higher enantiomeric excess. The final assembly sees a coupling with L-tartaric acid in ethanol or another polar aprotic solvent, using careful temperature control to avoid side product formation. Industrial production ditches column chromatography (too wasteful), favoring crystallization and filtration, which bring the desired salt out in high yield, high purity. Wastes get incinerated or treated according to strict regulatory regimes, as pharma plants can’t afford even the hint of cross-contamination.

Chemical Reactions & Modifications

A stroll through the literature finds this compound pulled or tweaked in dozens of syntheses. N-alkylation of the amino group modifies the hydrogen bonding profile, while selective protection or removal lets chemists test alternative routes to analogs that slide more smoothly into a final API. Under mild acidic or basic conditions, it’ll hold together, but push the system hard and the backbone opens up—useful if chasing analog libraries or breaking down imprecise mixtures. Reactivity studies focus on stability under light, heat, and varying pH, all essential in drug formulation, since breakdown products must meet tough limits on mutagenic impurities and process-related contamination.

Synonyms & Product Names

This chemical sports a formidable systematic name, but around warehouse benches and industry emails, you’ll hear shorthand like “tetrahydro-cyclopenta dioxole L-tart salt,” or even just “LCAT base” among technical teams. Product codes depend on the manufacturing site, and pharma catalogs might tuck it under “API intermediate—chiral platform.” Synonyms matter because supply chain managers and analytical testers need to match certificates and chromatograms, and mix-ups carry real regulatory implications. Naming conventions drift between regions, shaped by the main governing authority BP in the UK, EP for European projects, and USP for North America—each adjusting documentation standards and compliance expectations.

Safety & Operational Standards

Handling a pharma grade intermediate brings safety up front. Material safety data sheets flag it as a slight irritant, so operators in production lines pull on nitrile gloves and safety glasses before a bag even opens. Powder transfer hoods and laminar flow benches keep air clean, and routine monitoring for VOCs or airborne dust ensure chronic exposure doesn’t creep up. Spills and off-spec product get swept up, incinerated, or neutralized following hazardous waste protocols. Every move ties back to regulatory mandates, as batch mishaps or handling incidents risk not just worker health but workflow stoppage and regulatory inspection. Storage goes in dry, sealed containers at moderate temperature, away from incompatible acids or peroxides.

Application Area

Talk to colleagues in pharma development and you’ll hear this molecule crop up in the context of chiral salt formation, where matching the geometry of L-tartaric acid with a given lead candidate pulls just the right stereoisomer into a useful crystalline salt. That selectivity helps squeeze higher yields in chiral resolution, reducing material waste and process time. Some newer drug candidates design-in this skeleton for prodrugs meant to break down in the body’s mild alkaline environment, releasing active forms gradually. Process R&D engineers like it as a control agent for crystallizing out troublesome byproducts, leaving the desired material in the reactor. Those chasing generics monitor this material’s route patents and regulatory filings, as regional approvals either block or open major markets.

Research & Development

Active R&D keeps refining the synthesis route to this product, driven by both cost pressure and new green chemistry guidelines. Recent patent filings highlight biocatalytic routes that skip hazardous reagents, while custom catalyst developers push for asymmetric processes using cheaper, less-toxic metals. Academic labs track new solid-state forms and co-crystals, looking for humidity and thermal stability improvements. As analytical instruments sharpen, the purity and trace analysis requirements stretch labs to new levels; with regulators in the US and EU calling for ultra-trace detection of process-related impurities and even trace metals picked up from pipework. This space attracts startups with expertise in continuous flow chemistry, spinning reactions tighter and faster versus classic batch vessels.

Toxicity Research

Regulatory teams must stamp “pharma grade” only after reviewing a gauntlet of toxicity studies. In vivo assays in rodents and cell lines set the bar for oral and dermal safety, while bacterial mutagenicity screens look for red flags in breakdown products or intermediates. Acute exposures placed this molecule in the low-to-moderate hazard category, with high oral doses producing transient symptoms and no organ damage in standard models. Chronic repeat-dose tests come out clean when the compound lands in oral solid dosage forms, with no bioaccumulation and steady excretion profiles. Regulatory agencies pour through toxicity data and demand genotox profiles—making sure trace impurities in commercial lots don’t exceed tight thresholds, often set below 1 ppm for mutagenic risk.

Future Prospects

The road ahead for this chemical looks shaped by both regulatory trends and the pace of pharma innovation. Cost pressures drive continued process optimization, and advances in green chemistry signal new demands for cleaner, less wasteful routes. The push for higher purity, lower environmental impact, and broader chiral scaffold applications means demand from research and generic manufacturers stays robust. As new therapies demand tighter enantiomeric control and more adaptable salt forms, companies developing new analogs based on this skeleton could open further medical applications. With each new patent filing, process refinement, or novel application, the landscape for such molecules shifts, making experience and robust technical understanding just as crucial as chemical know-how on the bench or production line.




What are the main applications of 2-((3Ar,4S,6R,6As)-6-Amino-2,2-Dimethyltetrahydro-3Ah-Cyclopenta[D][1,3]Dioxol-4-Yloxy)Ethanol L-Tartaric Acid BP EP USP Pharma Grade?

Real Role in Drug Creation

Looking at the name, it might feel like something reserved only for chemists. The truth is, this compound shows up in the recipes behind plenty of familiar and life-saving medicines. You find it sold in pharma grade quality up to global standards: BP, EP, USP. Those three letters are no small oversight — they mean the compound matches the tests and purity needed for pills, injectables, and other uses tied to your health.

Most chemists, from my experience, value this sort of molecule because it helps engineer active pharmaceutical ingredients (APIs). It acts as either a key intermediate during synthesis or a stabilizer for complex molecules that can be stubbornly unstable otherwise. When researchers are trying to build out new antivirals or investigational drugs, a backbone like this provides an anchor. Drug developers want to keep the process predictable, with no wildcards during manufacture, and obtaining certified pharma grade material matters.

Building Modern Medicines

Therapies built for modern healthcare lean heavily on reliable raw materials. Take the world of antivirals and antibiotics. Some major names start from intermediates with cyclopenta[d][1,3]dioxole rings, especially where you need chirality and precise molecular structure. This is exactly where this compound steps up — bringing stereo-control and clean conversion during synthesis. The L-tartaric acid salt helps improve solubility, making downstream reactions go, or acting as a chiral counterion for separation of drug forms.

A chemist working on next-generation HIV meds or antifungals might grab this compound to help twist the molecule into just the right shape, so it locks onto biological targets and resists breakdown in the body. Small differences at the molecular level can change a drug’s safety, so using pharma grade material prevents unwanted side products. It also helps keep regulatory flagging to a minimum, which speeds up development.

Pharma Grade Matters for Patient Safety

Some say purity is only one piece of the puzzle, but after seeing recall after recall for poor ingredient sourcing, my experience tells me quality is everything. Using a pharma-grade compound with BP/EP/USP certification means fewer impurities and lower safety risks for patients. Every tablet, capsule, and injectable that relies on these intermediates depends on the repeatability of that starting material.

The broader truth is, most companies can’t risk a single contaminated lot. Double-checking against major pharmacopeias builds trust with both regulators and end-users. L-Tartaric acid versions of these molecules, specifically, grant a good salt form for studies and formulation, and can mean better performance for the final drug whether it's going to sit on a shelf or get administered by IV.

Moving Toward Smarter Manufacturing

With new medications rolling out faster than ever, scalable, well-documented intermediates prove their worth. Looking at routes that use this compound cuts down on waste and off-target byproducts, which supports both cost savings and cleaner production. Companies working in regulated spaces need reliable supply — and by choosing materials with high traceability, process validation gets easier. With growing demand for specialty APIs, compounds like this support innovation without sacrificing patient safety.

What are the storage and handling instructions for this product?

Why Storage Has a Direct Impact on Product Quality

People often skim right past storage instructions printed on packaging, trusting the basics: keep it cool, keep it dry. But storage isn’t just a box-ticking routine. Let’s say we’re talking about a medical supply—something like insulin, or even a simple over-the-counter ointment. The way it sits on a shelf can make the difference between a safe, effective remedy and a useless or even hazardous product. Keeping pharmaceuticals at room temperature can sound easy, but swing by a blistering hot warehouse in July and you’ll see just how fast a product’s integrity slips away.

Temperature Swings: More Than Just a Nuisance

Too much heat speeds up chemical reactions most people never notice. Creams split, pills break down, and foods spoil before their dates. One hot afternoon in an uncooled storeroom can undo months of careful manufacturing. I’ve seen it happen. I once lost a few vials of a vaccine because someone thought “cool” meant any air-conditioned room. The loss wasn’t just about money. Every spoiled product means someone down the line misses out or gets hurt. A simple rule works well here: Track the temperature. Use thermometers, and don’t trust memory or wishful thinking.

Humidity’s Sneaky Role

Moisture in the air sounds harmless, but it’s a quiet destroyer. Humid storage shortens shelf life and turns powders clumpy and tablets mushy. I learned this lesson while helping a friend run a small bakery. The summer humidity seeped into the storage area and bags of flour turned into bricks. It wasted inventory and cost us whole trays of baked goods. Using sealed containers, desiccant packs, and installing a basic dehumidifier kept things in check after that mishap.

The Cleanliness Factor

Dust and dirt invite bigger issues: bacteria, mold, pests. If one storage shelf picks up a problem, it usually spreads quickly. Regular cleaning isn’t glamorous but paying attention saves bigger headaches down the line. I’ve worked in kitchens and factories where a dusty corner hid a ruined batch of goods. Marking clear dates for cleaning, rotating supplies, and keeping spills tidy should form part of everyone’s regular checklist.

Safe Handling Protects More Than Products

Thanks to labels and training, most people know about protective gloves or masks when dealing with hazardous chemicals, but casual handling can still cause problems. Mistakes happen when workers skip steps—mixing incompatible items, storing strong-smelling goods with sensitive ones, using food containers for non-food products. Direct training, clear signage, and serious follow-through make all the difference. At home, kids can get into products stored under bathroom sinks—a little lock or high shelf keeps everyone out of trouble.

Improving Systems Helps Everyone

Manufacturers and retailers both set examples here. Barcodes that track batches, automatic alerts that warn about temperature changes, and packaging with easy-to-read instructions all lift the standard. In my experience, customers trust companies more when these systems are in place and working. Products stay fresh, shelf lives stretch, and safety issues drop. Clear communication—through websites, labels, or customer service—closes the last gap, helping users store things right from day one.

What is the typical purity and assay specification for pharmaceutical-grade material?

Looking at Purity Beyond the Label

Most folks picture drug purity as just a technical percentage on the blister pack. People in the lab obsess over those numbers for a reason. Purity goes hand in hand with safety. Getting purity wrong means more than a bruised reputation; patients trust their health to those little white tablets.

Clear Numbers in a Crowded Space

Pharmaceutical-grade material, by definition, isn’t a rough guess. Most active ingredients need to hit a chemical purity above 99.0%. Occasionally, standards loosen up to about 98.0%, especially for things that just can’t be cleaned up further because of how they’re made. This isn’t a shot in the dark. For something like acetaminophen, pharmacists expect at least 99% purity, confirmed by specific pharmacopoeia, like the USP or Ph. Eur.

Assay specification sets a boundary. It doesn’t just say “close enough.” Assay defines how much of the desired compound exists in the sample compared to any extras that sneak in during manufacturing, transport, or storage. Published assay specs for pharmaceutical ingredients usually read from 98.0% to 102.0%. Anything lower or higher starts raising red flags with regulators and, worse, doctors and patients who see recalls happen all too often.

Why Sticklers Get Hired

It’s easy to brush off a percentage here or there—until an impurity changes how the medicine works or someone gets sick. Allergen traces, leftover solvents, metal fragments, or even tiny changes in chemical structure shift a product from life-saving to dangerous. The thalidomide tragedy underscored the cost of impurities, teaching regulators and scientists that precision isn’t a luxury—it's protection.

I’ve watched teams spend months hitting these purity marks. Pharmacies only buy materials that come with certificates of analysis. Any vendor with inconsistent purity gets dropped. It isn’t personal—it’s business with lives in the balance.

Setting and Meeting Assay Specifications

Assay means more than a lab test. Regulators dictate a range—say, 99.0% to 101.0% for an antibiotic. That window takes into account some measurement wiggle room, but doesn’t make space for meaningful contamination. If a lab reports assay outside this zone, the product stays on the shelf—no matter how urgent the shortage.

The science backing these numbers isn’t static. Newer analytical techniques pick up lighter and lighter traces. Liquid chromatography, for example, now finds contaminants at the parts-per-million level. Today's “clean” label sometimes looks dirty by old standards.

How Companies Deliver

Keeping material pure starts long before the pill finds a bottle. Companies stick with trusted suppliers and test their inputs batch by batch. Big manufacturers run validation after every major change in process or supply chain. Inspections and certifications do more than fill a checklist; they set a hard line between trustworthy material and risky shortcuts.

Over the years, I’ve seen supply chains falter from poor oversight. Pipes corrode, solvents degrade, and new suppliers pop up with good sales pitches but no track record. Cutting corners leads to import bans and product recalls. The cleanest operations fix problems before they pile up.

Raising the Bar

As treatments get more complex, purity expectations only rise. Biotechnology and precision medicine demand sharper assays because even tiny setbacks mean bigger consequences for fragile patients. Labs and regulators must constantly ask: do our current purity and assay practices still protect patients? It’s pressure, but one the pharmaceutical world can’t afford to ignore.

Are there any known incompatibilities or hazardous reactions with this compound?

Why Chemical Compatibility Matters

Anyone who works around chemicals—whether in a lab, a factory, or even a cleaning crew—has probably heard a story or two about a close call. Some folks think of chemical incompatibility as just a technical issue. Truth is, it’s often a matter of life and death. I remember one night years ago, a janitor mixed “just a little bleach” with ammonia-based glass cleaner. Before he realized his mistake, the chemical cloud in that small restroom knocked him flat. That’s not a rare story. Mixing the wrong substances can turn harmless ingredients into a situation nobody wants.

Common Incompatibilities and Hazards

Plenty of compounds carry risk when combined. Take oxidizers, for instance. Pairing them with organic materials like paper, oil, or even dust often sparks fast, dangerous fires. Peroxides, chlorates, and nitrates all fall into this camp. Acids and bases, two staples of chemistry, can unleash a violent reaction when blended. Just look at hydrochloric acid and sodium hydroxide: add them together, and you’ll get a lot of heat and splashing.

Let’s think about another common danger—mixing acids with cyanide salts or sulfides. That can let out toxic gases such as hydrogen cyanide or hydrogen sulfide, both deadly with just a breath or two. Storing these sorts of materials together isn't just risky. It's reckless. Even “stable” chemicals can cause a stir if stored in certain temperatures or exposed to sunlight for too long.

Why Real-World Stories Matter

People trust labels and safety sheets. But accidents tend to happen when someone overlooks small print or assumes a little mixing won’t hurt. I worked with a crew responsible for hospital sterilization. We always checked the cleaning products list, yet mistakes still sneaked in during busy shifts. One afternoon, new staff scrubbed with bleach and followed up with acidic restroom cleaner. The whiff of chlorine set off the smoke alarms and left two folks coughing outside for an hour. Most injuries from chemical reactions aren’t dramatic explosions, but they can still scar lungs and skin for years.

Science Behind the Danger

Chemistry rests on bonds and energy. Release that energy the wrong way, and you face heat, flames, toxic fumes, or even metal fragments flying around. Some substances act as catalysts, speeding up unexpected reactions. Water, for example, reacts dangerously with sodium or potassium metals, creating caustic soda and hydrogen gas ready to explode from the tiniest spark. Even seemingly safe plastics will break down in contact with certain solvents, dripping goo into a drum and contaminating everything inside.

Solutions: Training, Storage, and Respect

No amount of fancy gear will fix a cavalier attitude. The best solution starts with better training. Regular safety drills and chemistry refreshers make a real difference. Clear, color-coded labels and closed, segregated cabinets keep risky combinations apart. Emergency eyewash and showers by every workspace give people a shot at minimizing injury if something goes wrong. For businesses, routine updates to Safety Data Sheets—digital or paper—help everyone keep up with changing knowledge as new risks get discovered.

People rely on chemistry every day for cleaner homes, safer cars, and better medicine. That trust only gets earned by putting safety first, learning from mistakes, and respecting rules written in sweat and, unfortunately, sometimes worse. Work doesn’t stop, but neither should the focus on chemical compatibility—for everyone’s sake.

Is there documentation available, such as Certificate of Analysis (CoA) and Material Safety Data Sheet (MSDS)?

Trust Starts With Information

Walking into a lab or a facility, it helps to know exactly what’s in each bottle or drum. That kind of confidence comes from good documentation, especially things like the Certificate of Analysis (CoA) and Material Safety Data Sheet (MSDS). Years of working alongside chemists and quality control folks have made that clear for me. No one wants to discover a surprise impurity later on. The CoA spells out exactly what’s inside and how it measures up to the standards—like checking if your flour is really just flour before you bake a loaf for someone with allergies.

Authenticity Starts Before the First Test

Suppliers who hand over full documents right away, instead of dragging their feet, know their stuff. That attitude saves everyone a headache and often points to a more trustworthy partner. People, myself included, have learned the hard way what happens when reports are missing. You pour resources into a project, then trip over details that should have been caught at the start. The MSDS, for example, describes how to handle chemicals safely and what to do in an emergency, right down to cleaning up a spill or treating skin exposure. A fire marshal and several safety officers I know won’t let any material into the building without it—and for good reason.

Transparency Lowers Business Risk

Plenty of companies want to avoid downtime or liability. One wrong move with an unknown or misrepresented chemical can bring everything to a halt. Attorneys might get involved. Regulatory penalties rack up quickly. Regulators expect evidence that folks actually checked what they’re working with. That’s why organizations like OSHA and ISO have clear rules about documentation, and ignoring them can actually lead to criminal charges if someone gets hurt.

Supporting Good Science and Honest Products

Without solid paperwork, research can go south fast. I’ve seen a team spend weeks running an experiment, only to scrap results after realizing the main ingredient was off-spec. The original CoA would have helped catch that. Pharmaceutical firms depend on rock-solid documentation as part of their quality assurance: if a drug batch causes side effects or fails, investigators follow the paper trail back to the source. Gaps in that chain mean somebody, somewhere, cut corners. That gets noticed not just by regulators, but by customers and patients as well.

Accessible Solutions

A lot of folks in the field advocate for more open systems. Secure digital platforms make it quicker to track down CoAs and MSDS files, instead of hunting through dusty file cabinets or drawn-out email threads. Training programs teach new hires exactly what to look for in these forms, making it less likely mistakes slip through. Some chemical marketplaces flag suppliers who post documentation by default, which I’ve seen steer buyers away from vendors who try to skip steps. Governments and professional organizations post templates or minimum requirements online, so small operations and big factories both know how to comply.

Everyone Benefits From Strong Documentation

No one walks into a project hoping to cut corners, not on purpose. CoAs and MSDSs close off that risk. They protect everyone—scientists, workers, end users, even folks down the supply chain. A culture of transparency and accountability starts with straightforward paperwork like this. Getting the details and sharing them is the least people can do if they care about safety, quality, and honest work.

2-((3Ar,4S,6R,6As)-6-Amino-2,2-Dimethyltetrahydro-3Ah-Cyclopenta[D][1,3]Dioxol-4-Yloxy)Ethanol L-Tataric Acid BP EP USP Pharma Grade
Identifiers
CompTox Dashboard (EPA) DTXSID30898667