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N4-Benzoylcytosine BP EP USP Pharma Grade: Insightful Commentary

Historical Development

N4-Benzoylcytosine didn’t pop up by chance. Early interest in modifying nucleobases began in the middle of the twentieth century, as researchers tried to untangle the secrets of nucleic acids and push the limits of synthetic chemistry. This compound drew attention because chemical tweaks on the cytosine skeleton offered footholds for wider applications, not just for molecular biologists but also for those developing active pharmaceutical ingredients. In classic research papers from Japan and Europe through the 1970s, several teams explored acylation methods to help shield amino groups, leading to more selective reactions downstream. Its application soon spread as pharmaceutical groups discovered that N4-acyl derivatives, like the benzoyl type, protected reactive sites and helped streamline later steps in drug synthesis.

Product Overview

N4-Benzoylcytosine pharma grade lands in a unique spot. As a cytosine derivative, its structure features a benzoyl group planted at the N4 position, which distinguishes it from plain cytosine. That extra group blocks certain reactions, steering chemists toward single products and making the compound useful as both an intermediate and a research standard. High-purity forms—those meeting BP, EP, and USP requirements—ensure that APIs made with this material won’t stray outside strict quality boundaries. This means lower batch-to-batch risk, which is something lab managers and regulatory teams tend to appreciate after a few uncomfortable audits.

Physical & Chemical Properties

N4-Benzoylcytosine appears as an off-white or light beige crystalline powder. It carries a melting point usually in the range of 210–215°C, based on batch purity and crystallinity. Its solubility pattern shows reasonable performance in dimethyl sulfoxide and dimethylformamide, but water barely registers on the chart, underscoring the effect of the added benzoyl group. Chemically, that N4-benzoyl makes the amine less nucleophilic, so reactions that target the 4-amino group on cytosine won’t happen until the group gets removed. Elemental analysis lines up with the molecular formula, and high-quality reference standards allow synthetic and analytical labs to match spectra against known fingerprints.

Technical Specifications & Labeling

Pharma-grade N4-Benzoylcytosine goes beyond minimum thresholds for impurities. Product sheets typically reference key tests like HPLC purity above 99%, loss on drying under 0.5%, and heavy metal content below 10 ppm. Labeling standards for BP, EP, and USP batches require traceability codes, clear expiry dates, and storage instructions to protect against temperature swings that might drive decomposition. I’ve seen plenty of lot certification paperwork that runs longer than a chapter book, but these rules matter when lives depend on what enters the drug supply.

Preparation Method

Synthesis usually starts with cytosine and benzoyl chloride as the main feedstocks. The process takes place in anhydrous solvents, with base present to absorb hydrochloric acid given off in the reaction. By running the process under controlled temperature, chemists avoid over-acylation or formation of unwanted byproducts. After completion, the product gets filtered and may see one or two recrystallization steps before heading to analysis. In some cases, upgraded processes swap out classical hazardous reagents for safer, greener options, aiming to check boxes for both environmental and regulatory goals.

Chemical Reactions & Modifications

N4-Benzoylcytosine serves as a blocking group in multi-step syntheses, particularly during the construction of modified nucleosides and oligonucleotides. After its protective job is done, the benzoyl group typically gets clipped off under mildly basic conditions, freeing up the original N4 position for further modification. I’ve watched teams in oligonucleotide labs weigh the trade-offs of different protecting groups, but the benzoyl type stands out for reliability—not too stubborn, not too labile. Derivatives have even cropped up in the design of enzyme inhibitors, hinting at untapped uses in chemical biology.

Synonyms & Product Names

This compound wears a handful of hats in standard nomenclature: 4-Benzoylcytosine, N4-Benzoyl-2-oxy-4-amino-pyrimidine, and plain old N-Benzoylcytosine show up across different supplier catalogs. CAS number and batch identifiers help pin down which compound you’re holding. Keep an eye out for international variation—certain European catalogs prefer the older pyrimidone designations, echoing naming conventions from earlier decades.

Safety & Operational Standards

Handling N4-Benzoylcytosine in regulated spaces requires more than a simple dust mask. Safety data sheets flag potential skin and respiratory irritant properties. Full PPE includes gloves, goggles, and dust control. Storage stays dry and cool, usually in tightly sealed HDPE or amber glass, to fend off moisture and photodegradation. Waste gets handled according to hazardous organic protocols, especially during prep-scale operations. Auditors look for clear segregation and written standard operating procedures for everyone who touches the material, from receiving through to weighing and dispense.

Application Area

N4-Benzoylcytosine’s main job is to act as an intermediate in building nucleoside analogs. These find their way into antiviral and anticancer drugs, where precision at every step matters. In synthetic chemistry labs, it anchors protocols for assembling base-modified oligonucleotides, including those used as PCR probes or gene silencers. The reliability of pharmaceutical-grade supplies makes a difference here, since single-digit contamination can derail an entire batch or clinical study.

Research & Development

Current research leans heavily into optimizing preparation methods, with plenty of attention paid to yield, purity, and waste reduction. Teams in medicinal chemistry explore new derivatives by swapping the benzoyl with other aromatic groups to tune biological properties. Analytical groups focus on fingerprinting impurity profiles using mass spec and NMR, looking for anything different from the gold-standard reference spectra. Universities sometimes spotlight N4-Benzoylcytosine in upper-level lab courses, hoping future chemists get comfortable working at the interface between small organic molecules and nucleic acid biochemistry.

Toxicity Research

Public data on N4-Benzoylcytosine’s toxicity stays somewhat limited, mostly because it serves as an intermediate and doesn’t enter the body except as trace residuals in final drugs. In-house studies from chemical suppliers highlight low oral toxicity in animal models, but protocols still require risk assessments for possible skin and eye irritation. Once the benzoyl group comes off in subsequent reactions, end products enter much more intense scrutiny for mutagenicity and long-term effects. Regulatory authorities also require periodic reviews as part of ongoing pharmacovigilance efforts, particularly as analytical capabilities to detect lower residue levels keep improving.

Future Prospects

N4-Benzoylcytosine won’t grab headlines, but has a solid role in the future of drug synthesis and chemical biology. As demand increases for modified nucleotides—driven by new gene therapies and vaccine technologies—the need for high-purity intermediates only rises. Process chemistry teams figure out how to make preparations greener and safer, using continuous-flow setups and nontoxic reagents where possible. Digital quality tracking and machine learning help spot outliers before they interrupt production. As research digs deeper into bespoke oligonucleotide design, this old workhorse will likely find new jobs in areas nobody expects, all while standards keep tightening.




What is the primary use of N4-Benzoylcytosine BP EP USP Pharma Grade?

Key Active Ingredient for Antiviral and Anticancer Drug Discovery

N4-Benzoylcytosine doesn’t make headlines, but in chemical and pharmaceutical labs, its importance stands out for anyone serious about modern drug development. Picture this: a quiet white powder—seemingly unremarkable—becomes a central puzzle piece for chemists who want to tackle stubborn viral infections or some of the deadliest cancers. The pharmaceutical-grade version, made to the strictest BP, EP, and USP standards, doesn’t just add a layer of promising reliability; it allows real clinical progress.

Pharma manufacturers prefer N4-Benzoylcytosine for a simple, practical reason. In drug synthesis, it serves as a key building block. Take cytarabine, used to treat certain leukemias. Anyone who’s seen the struggle of patients battling aggressive blood cancers knows the desperate need for safe, effective medication. N4-Benzoylcytosine acts as a starting agent in the creation of cytarabine. The process takes precision, and pharma-grade ensures that everything from purity to consistency hits the mark.

Roles Beyond Blood Cancers: Expanding the Toolbox

Scientifically speaking, the benzoyl group in N4-Benzoylcytosine protects sensitive sites on the cytosine ring during synthesis. Anyone mixing batches in a lab can tell you what a headache it is to deal with chemical breakdown or unwanted by-products. By starting with a protected form, chemists keep unwanted reactions at bay and end up with cleaner, more potent final products. This benefits not just research teams, but also the patient waiting for therapy that truly works.

Pharmaceutical development today leans heavily on building blocks like this compound, especially for making pyrimidine analogues. These analogues don’t just stop at cancer. Their structure can block viral enzymes, which is why research teams across the globe use N4-Benzoylcytosine in their hunt for new antivirals. Modern lab results show that keeping contaminants out of these intermediate chemicals can be the difference between success and a failed batch—no minor issue when lives depend on new treatments reaching the market.

Regulations, Safety, and the Push for Consistency

Sourcing quality chemicals impacts everything from bottom-line costs to the health outcomes for real people. Pharma-grade compounds come backed with data sheets and certifications that reassure regulatory agencies. There’s enough uncertainty in the world of illness and medication without worrying whether your starting chemical will introduce new risks. This accountability, laid out by BP, EP, and USP protocols, gives drug makers and their customers peace of mind.

For anyone who has ever spent time around a clinical trial, the journey from laboratory to hospital bedside means every gram of input material must be traceable and as pure as possible. Subpar chemicals can derail years of research, spoil promising therapies, or worse, compromise patient health. Pharma-grade N4-Benzoylcytosine often costs more than its industrial cousins, but the investment pays back through increased safety and a smoother path through regulatory review.

Looking Forward: Meeting the Challenges in Drug Manufacturing

The push for better, faster, and safer medicines runs up against global challenges—from unstable supply chains to ever-present regulatory scrutiny. Reliable, pharma-grade intermediates like N4-Benzoylcytosine are the quiet backbone supporting headline-making discoveries. By prioritizing high standards, the pharmaceutical industry increases its odds of landing new cures in real clinics, helping patients who need them most.

What are the storage conditions and shelf life for N4-Benzoylcytosine BP EP USP Pharma Grade?

Keeping N4-Benzoylcytosine in Top Shape

Storing pharmaceutical ingredients isn’t just a matter of tossing a drum on a shelf. Take N4-Benzoylcytosine at BP, EP, and USP grades for example. A facility that pulls this compound off the loading dock and just sticks it in a stockroom risks ruining both its quality and the money invested.

Job one is temperature. Set the dial on the cool side, right around 2°C to 8°C. Most controlled-room storage hovers in this range, and this small change has a big impact. Heat quickens the pace for impurities to show up, kicking off degradation faster than most realize. My years in pharma production taught me that even short exposure to steamy or stuffy storage can cut shelf life and raise the chance the powder fails quality specs.

Next up is humidity. Humidity and cytosine derivatives clash. Water creeps into containers and prompts hydrolysis or clumping. Unsealed bags sag. The solution is to use airtight, light-resistant packaging, usually high-density polyethylene or amber glass bottles, and keep humidity low, generally under 60%. Those desiccant sachets stuffed into every package aren’t just a nuisance on the floor—they’re a frontline defense.

Anyone who’s seen a batch exposed to sunlight knows that UV rays ruin more than beach days. Light, specifically the high-energy part of the visible and ultraviolet spectrum, accelerates chemical changes in N4-Benzoylcytosine. Opaque containers reduce the risk, and dark storage spaces outperform brightly lit labs every time. During one especially painful audit, I saw two drums left by an open window; neither batch made it to production.

While most suppliers recommend shelf lives of two to three years under proper storage, those numbers count for little if the product sits uncapped or in humid, hot spaces. In my own experience, product tested after 36 months in a tightly controlled vault performed nearly as well as fresh—it’s neglect that shortens lifespan, not the calendar page.

Why These Details Matter

Pharma quality depends on every link in the chain. A breakdown at storage means purity drops and patients pay the price. In the last decade, several recalls traced back to simple mistakes—leaky containers, sunlit warehouses, skipped humidity checks. These avoidable errors add up, and every chemist or warehouse manager who’s seen a waste drum fill with lost API knows the frustration.

It’s not just about avoiding waste, either. Most regulatory bodies want documented evidence that the material’s spent life in ideal conditions. If storage slips, every downstream process comes under suspicion, which ties up good product and ruins supply schedules. Shelf life loses all meaning if warehouses cannot support temperature and humidity logs.

What Works in the Real World

Automated monitoring saves effort and limits surprises. Remote sensors catch a spike in temperature or humidity before it ruins weeks of inventory. Clear SOPs and a simple sign-off sheet make staff responsible for checking seals and replacing desiccants. Instead of guessing whether a drum has spent months in the wrong spot, a proper log gives confidence to everyone, from auditor to formulator.

Stick with airtight, sealed, and fully labeled containers. Educate anyone on the floor about why the storage room stays locked, cold, and dark. Every month, sample retained batches and run spot-checks for color or texture shifts. These steps don’t cost much but prevent far more expensive rejections or recalls.

N4-Benzoylcytosine gets the same respect as any valuable medication component. The attention paid to storage outclasses any technical fix later. Solid storage isn’t just a GMP checkbox; it’s the backbone of well-tested, reliable pharma production.

Is N4-Benzoylcytosine BP EP USP Pharma Grade compliant with BP, EP, and USP pharmacopeia standards?

Real-World Pharma Standards: BP, EP, and USP

There’s no shortcut when working with pharmaceutical ingredients. Every manufacturer of N4-Benzoylcytosine that calls their material “BP/EP/USP Pharma Grade” makes a promise to doctors, patients, and regulators. These acronyms—BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia)—point to the highest expectations, not just in purity, but in how a substance gets produced, tested, and traced.

I’ve navigated countless specifications in pharmaceutical projects and have seen what happens when companies claim full compliance while only ticking off the basics. BP, EP, and USP standards aren’t checklists that suppliers rush through. They draw strict lines around impurities, establish requirements for identification, and demand precise limits for assays and residual solvents.

Actual Commitment Versus Box-Ticking

It’s easy to slap a pharmacopeia label on technical paperwork. Real compliance shows up in detailed certificates of analysis and open-door audits. One time, a seemingly reputable supplier submitted paperwork for N4-Benzoylcytosine that looked impressive on the surface. A closer look revealed substitute methods, like using non-pharmacopeial solvents for crystallization. This shortcut might not show up on a basic HPLC reading but could introduce subtle risks that hurt patients down the line.

These pharmacopeias set their own procedures for things like melting range and related substances. USP’s approach might differ from EP’s on residual solvents. There’s a difference here between “meeting the label” and “meeting the standard.” Companies that take quality seriously document everything—they provide full batch traceability, impurity profiles, and reference spectra, not just a summary page.

Why the Details Protect People

Cutting corners in the pharma supply chain often starts with vague language around standards. Some vendors assume that passing a few major tests means a clean bill of health. But N4-Benzoylcytosine goes into chemical processes that end up in people’s bodies. Missing a trace impurity, ignoring a limit on heavy metals, or skipping an identity confirmation test all invites risk: failed regulatory audits, batch recalls, or, worst of all, harm to patients.

One industry friend told me about a manufacturer who believed visual inspection covered identification tests. Regulators rejected a vaccine batch because the supplier had skipped BP’s thin-layer chromatography identification—a simple, cheap test. This wasn’t just a paperwork error; it meant lost medicine, wasted work, and compromised patient trust.

Fixing Compliance Gaps

Solving this isn’t about adding more forms—it’s about building a traceable, transparent supply line. Suppliers must share genuine lab data for each relevant pharmacopeia, matched with batch-specific reports and clear proof their methods align with official protocols. Auditing suppliers in person, testing random samples in a third-party lab, and insisting on full disclosure of test results catches issues early.

Group purchasing contracts should require direct confirmation that batch-specific N4-Benzoylcytosine meets every standard in BP, EP, and USP, not just a generic promise. If suppliers start falling short, buyers should switch to vendors who show real data rather than handwaving about compliance. The pharma world moves too fast, and mistakes travel too far to settle for anything less.

Trust Built on Data, Not Hype

N4-Benzoylcytosine holds its place in critical synthesis routes. The only way to guarantee safety is through full, honest compliance with pharmacopeia standards. Actions beat words every time. Lab testing, clean batch histories, and transparent supply chains keep the industry—and the patients who rely on it—protected from shortcuts and empty assurances.

What are the available packaging options for N4-Benzoylcytosine BP EP USP Pharma Grade?

The Realities of Pharmaceutical Packaging

Packaging makes a huge difference for any pharmaceutical compound, including N4-Benzoylcytosine. You only need to spend an afternoon in a quality control lab to understand how much trust gets placed in sturdy drums and well-sealed bottles. There’s no room for careless handling—not when the safety of a whole production batch rests on how well the raw materials stay protected.

Drums Built for Bulk

Large-scale buyers often look at steel or high-density polyethylene (HDPE) drums. These drums, usually available in 25 kg or 50 kg sizes, protect against moisture and avoid contamination. I’ve seen what happens if a drum’s seal isn’t perfect: the powder can clump, or worse, turn unusable. Pharma operations can’t afford to risk even minor degradation, so manufacturers put a lot of faith in tamper-evident, FDA-approved linings. As more requirements focus on traceability, barcoding labels and serial tracking have become standard parts of these drums, not afterthoughts.

Triple-Layer Bags: An Industry Staple

Triple-layer bags set inside fiberboard drums can keep N4-Benzoylcytosine away from direct contact with air and light. I’ve seen colleagues in procurement push for this packaging, especially if material will sit in storage for a few months. The polyethylene inner lining offers peace of mind against leaching, and the outer kraft paper gives enough strength for rough handling during shipping. With some facilities working in humid or damp regions, switching to moisture-barrier bags inside the drums has lowered rejected lots and claims about product spoilage.

HDPE and Amber Glass Bottles: For Sensitive Workflows

Research labs usually need smaller quantities. HDPE bottles, sometimes amber in color, show up often in these settings. These bottles resist shattering, block light, and hold up well under cold storage. I remember one incident where a bottle cracked in a -20 °C freezer—it was a cheap generic, not an HDPE pharma bottle—and the resulting lost material set an entire project back by days. It’s not just about containing the powder, but making sure it still works six months later. Amber glass remains a classic choice where chemical interactions raise concerns with plastic, especially for sensitive or regulatory-heavy uses. Even 100-gram amber glass containers pop up on order sheets for reference standards or custom syntheses.

Vacuum-Sealed and Inert-Gas Packaging

Some compounds react with oxygen or water vapor, so vacuum-sealing or using inert nitrogen-flushed bags adds a safety net. I’ve had suppliers argue the cost, but after seeing oxidation ruin a kilo of a key intermediate, the extra steps start looking a lot more sensible. These options limit the material's contact with air through months of storage and help meet the purity specs that regulators target. Cost aside, a reliable vaccum seal can mean the difference between a “pass” and “fail” in the final QC results.

Improving Packaging Choices

Everyone in the supply chain, from QA to dispatch, gets a say in packaging upgrades. I’ve watched teams debate switching from metal drums to lighter, recyclable plastics, or switching out old-style seals for modern, induction heat-sealed options. Regulatory changes push the industry to review what’s used every couple of years. The real winners listen to feedback from all ends—synthesizers, shippers, and storage crews—before settling on one package over another. Some vendors even offer trial runs, letting end users stress-test the containers in real-world conditions.

Moving Forward with Confidence

Packaging demands attention to real-world handling, local climate, regulatory pressures, and production needs. Better packaging doesn’t just keep the chemist happy—it stops lost inventory, wasted hours, and expensive recalls. In the world of pharma-grade N4-Benzoylcytosine, well-chosen packaging gives the entire process a fighting chance at success.

Can you provide the certificate of analysis (CoA) and safety data sheet (SDS) for N4-Benzoylcytosine BP EP USP Pharma Grade?

The Real Value of Transparency in Pharma

Asking for a Certificate of Analysis (CoA) and a Safety Data Sheet (SDS) has become second nature for those working with ingredients like N4-Benzoylcytosine at the BP, EP, or USP Pharma Grade. Some folks shrug these documents off as paperwork—just more files to cross off in a compliance checklist. I've spent years watching how deeper trust between pharma producers and buyers doesn’t begin and end with a stamp. It often comes down to how openly you share information and what’s actually inside the documents you hand over.

What You’re Really Getting With a CoA

The CoA isn’t just a summary of numbers and test results. It offers a direct look at quality control and how seriously manufacturers take their responsibility. It shows exact test results for things like purity, water content, pH, and specific impurities. This gives the pharmacist or scientist a clear sense of what’s in the barrel or bottle. If someone skips this step, questions naturally surface: Are impurities documented? Could a contaminant slip through that wrecks a batch downstream? Data from the U.S. Pharmacopeia has shown that controlling just one contaminant early on can prevent millions in recalls and failed studies. Nobody wants to run assays in a lab only to discover that a single out-of-spec batch ruined months of work.

The Hidden Work Behind the SDS

Working with lab chemicals, most scientists have seen at least a few scary accidents in their time. The SDS sometimes gets tossed into drawers or buried in emails, but suppose an incident happens—like a spill during preparation or someone receives unexpected exposure. Suddenly, the SDS isn’t just more paperwork. It's a lifeline, spelling out fire hazards, reaction risks, disposal steps, and emergency medical tips. N4-Benzoylcytosine sits within a class of cytosine-derivatives known for medical potential, often used in drug formulations. While it usually behaves itself, handling any pharma-grade compound calls for upfront knowledge about what to do during emergencies. The SDS gives the full breakdown—routes of exposure, stability, recommended personal protective equipment, and what’s needed to keep the lab and wider workplace safe.

Trust Built on Data: Earning Confidence

Regulators keep tightening expectations for traceability, and both buyers and sellers must keep their guard up. There’s been a rise in counterfeit raw materials and tainted lots making their way into global supply chains. In this landscape, a rock-solid CoA matched with an up-to-date SDS isn’t just a “nice to have”—it’s how companies protect their people and their reputation. Skipping documentation means some people will walk away, unwilling to gamble on unknown risks. Even the FDA's warning letters spell out that lack of traceability remains a top reason for enforcement actions in the pharma sector. Proper paperwork protects business relationships and provides a safety net when things get unpredictable.

Making Information Sharing the Norm

Some suppliers already set a high bar by uploading these documents into order systems before the first shipment arrives. Others drag their heels, relying on email requests that slow things down. Strong partnerships form around open access, where documentation is always a click away and up to date. My best experiences in the field have come from transparent, no-hassle collaboration—where a quick look at a CoA or SDS means confidence in the next step, not anxiety or second-guessing.

What Still Stands in the Way

Some holdouts worry about sharing sensitive technical details, citing competitive fears or trade secrets. Truth is, much of this information has to flow if we want to stop contamination and guarantee the integrity of any medicinal product. Cooperating fully on documentation doesn’t just keep regulators happy; it saves lives, money, and careers, too. Anyone dealing with batches of N4-Benzoylcytosine—no matter how “routine”—deserves up-to-date, plain-spoken support through easy access to CoA and SDS paperwork. Getting that right is just how sound science, safety, and trust get built for the long haul.

N4-Benzoylcytosine BP EP USP Pharma Grade
Identifiers
3D model (JSmol) `3D model (JSmol) string` for **N4-Benzoylcytosine**: ``` CC1=NC(=O)N(C(=O)N1)C2=CC=CC=C2 ```
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N4-Methylcytosine
Benzoyl chloride
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