Chengguan District, Lanzhou, Gansu, China sales01@liwei-chem.com 1557459043@qq.com
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Azone Powder BP EP USP Pharma Grade: A Grounded Look

Historical Development

People working in pharmaceutical research during the late 20th century realized early on that making drugs more effective sometimes meant getting them through skin, not just through a pill. That practical need led to deeper work around substances called penetration enhancers. Azone, known in chemistry texts as laurocapram, stood out during the 1980s. Researchers tested it in labs and saw dramatic changes—medicines passed through skin layers with more ease, not only for pain relief creams but also for hormone patches and localized treatments. Agencies in Europe and the United States took notice, so official quality standards developed in the BP, EP, and USP pharmacopeias. My own time in the lab taught me that the path from chemical curiosity to pharmacopeia listing isn’t smooth. Study after study, batches tested, unexpected impurities discovered—getting Azone powder recognized as BP EP USP grade required lots of persistence.

Product Overview

Azone powder doesn’t look remarkable at first glance: a pale, waxy solid, little to no smell, much like so many inactive pharmaceutical ingredients. Dig deeper, though, and every researcher sees its value as a true enhancer for skin absorption. Its registration under BP, EP, and USP marks means that major health authorities have defined what high-grade Azone is supposed to be—free from traces that cause harm, showing reliable purity, and produced with tight controls. Most suppliers keep these standards at the top because failing quality checks sets projects back months, even years. In practice, pharmacists rarely use Azone by name with patients, but when compounding creams and gels for long-term skin treatments, they rely on it. The powder form makes it easy to measure accurately, vital when formulating products where precision affects safety.

Physical & Chemical Properties

Azone’s chemical makeup—N-dodecylazepan-2-one—isn’t just a technical detail. I’ve handled it in the lab, and its waxy consistency helps it melt around 62-66°C. Solubility shows up as a practical point: it mixes with most organic solvents, including ethanol, isopropanol, and propylene glycol, while it barely dissolves in water. This seems limiting until we remember that most topical drug carriers are semi-solid or oil-based. Azone’s low vapor pressure means evaporation doesn’t complicate formulations during mixing. Its chemical stability handles typical temperature variations a pharmacy sees, avoiding surprises during storage or transport. True, you won’t find it in every over-the-counter cream, but dermatologists and compounding pharmacists favor stable, predictable ingredients, especially with sensitive skin issues.

Technical Specifications & Labeling

Specifications spell out what separates pharma from industrial quality, not just paperwork but real-world confidence. Each Azone BP EP USP batch carries a clear label: purity above 98%, controlled moisture content, well-documented melting point. Tests rule out heavy metals, unwanted byproducts, and microbial contamination. Anyone in pharmaceutical production rolls their eyes at unclear labeling, so trusted suppliers post full specifications online, with batch-specific COAs. The importance of these details can’t be overstated—anything less puts patient safety and product reliability at risk.

Preparation Method

Azone’s route from lab idea to powder in a jar involves a careful process. Professional producers start with raw laurylamine, reacting it with caprolactam derivatives. The process needs precise temperature and pH controls so unwanted side reactions don’t tank the yield. This step, repeated thousands of times in industrial settings, highlights the gap between chemical theory and large-scale practice. After reaction and purification steps—often distillation and recrystallization—the final powder achieves pharmacopeia-grade purity. Chemists working with Azone know every shortcut risks introducing instability or residual solvents. Strict documentation trails follow each finished lot so hospitals and compounding pharmacies can trace its quality back to every step.

Chemical Reactions & Modifications

Azone powder, once isolated, handles mild conditions. Chemically, it tolerates typical pharmaceutical formulation steps, rarely decomposing unless extremely strong acids or bases are present. Researchers in drug delivery sometimes tinker with its structure, tweaking the alkyl chain length, or blending with other permeation enhancers. They hope these changes fine-tune its impact, whether boosting effect or cutting irritation to sensitive skin. I’ve seen recent research focusing on hybrid chemical modifications, attaching polymers or combining Azone with nanocarriers, aiming to help stubborn drugs cross the skin without harming its layers. The bulk of the industry sticks with the unmodified grade, proven by studies and patient records, because each change brings more regulatory steps.

Synonyms & Product Names

Azone doesn’t only show up by its main name. Industry insiders recognize synonyms like laurocapram, 1-dodecylazacycloheptan-2-one, and sometimes trade names such as Epaderm. Pharmacopeia listings keep the main chemical name for standardization, but compounding references and global suppliers may rotate between these terms. For anyone ordering Azone, misreading a name risks buying the wrong grade—raw technical powder instead of pharmacy quality, or vice versa. That confusion brings real safety dangers, not just paperwork errors.

Safety & Operational Standards

Azone powder, like any active chemical, demands respect in handling and safety. Published MSDS materials point to the need for gloves, goggles, and well-ventilated mixing areas, especially when working with large amounts. Inhalation at powder stage can cause mild irritation; skin contact in concentrated form occasionally leads to redness or itching. Over the years, careful blending with carrier oils or base creams prevents almost all unintended side effects. Regulatory inspections—for labs, production lines, even pharmacies—demand full records of storage, batch testing, and cleaning procedures. Failing to meet these standards leads to shutdowns or license loss. My own lab experience taught me to never assume with chemicals; checking lot numbers and expiry dates really matters.

Application Area

Azone’s reputation in pharmacy rests almost entirely on its knack for making medicine work through the skin, not through the gut. It features in transdermal patches used for pain relief, contraception, hormone therapy, and in compounded topical creams for chronic inflammatory conditions. Prescriptions for eczema and psoriasis frequently contain Azone to get active ingredients where they’re needed fast. In veterinary medicine, professionals value its effect in minimizing the amount of active drug needed to treat surface infections. Fewer side effects, better patient compliance—those aren’t abstract goals but what makes prolonged topical treatment sustainable for real people.

Research & Development

Drug delivery researchers focus a lot of time and resources on improving transdermal formulations. Recent work shows interest in combining Azone with novel nanoparticles, microneedle systems, or layered patch technologies for controlled drug release. Laboratories at leading pharmaceutical companies and academic institutions publish studies that measure how Azone interacts with different molecular weights and lipid compositions in creams. Most pharmacy students learn about it in the context of pharmaceutics and formulation science courses, often getting hands-on training blending model drug gels with and without Azone to see the impact directly.

Toxicity Research

Safety research forms the main foundation for accepting any new pharmaceutical excipient. For Azone, the past thirty years brought plenty of investigation. Animal toxicity trials monitored skin irritation, systemic absorption, and long-term exposure effects. Most studies reported only mild skin reactions unless extremely high doses were used, and systemic toxicity remained low in comparison to other enhancers. A few reported cases of allergic contact dermatitis in sensitive groups, highlighting the need for patient monitoring during long-term use. Regulatory agencies continue tracking possible rare adverse outcomes, using pharmacovigilance data from hospital and retail settings. Anyone formulating with Azone for pediatric or elderly patients sees these toxicity profiles as essential reading.

Future Prospects

The next decade looks bright for Azone, but change happens incrementally in pharmacy. Strong demand for smarter drug delivery pushes ongoing innovation in Azone combinations and modified forms. Companies experiment with advanced liposomal carriers, pH-sensitive hydrogels, and digital health devices that measure drug delivery through skin in real time, often powered by Azone’s strong permeation effect. Public health pressures—antibiotic resistance, rising rates of chronic skin disorders—drive interest in improving on established topical treatments rather than starting from scratch. From a practical standpoint, the standardization enforced by BP EP USP lays a safe path for continuous quality assurance, even as research teams push the boundaries of how Azone powder improves patient outcomes.




What is Azone Powder BP EP USP Pharma Grade used for?

Why Azone Powder Matters in the Medical World

Azone powder, bearing names like BP, EP, or USP grade, pops up everywhere in pharmaceutical conversations for a good reason. As someone who tracks how drug innovation keeps people healthier, I’ve seen firsthand that laboratories treat this chemical as their secret sauce. No, it’s not the magic behind a miracle cure, but it deserves some respect for the work it does—especially in making transdermal medicines useful, predictable, and efficient.

The Science of Better Drug Delivery

Doctors keep asking for safer, faster-acting skin creams and patches. Azone succeeds here because it breaks down the natural barrier of skin just enough to let drugs slip through without causing chaos. Anyone who’s tried to use a topical medication knows how frustrating it feels not to get relief due to poor absorption. Studies published in the Journal of Controlled Release show that Azone increases the movement of large molecules, letting them actually reach the spot doctors target.

Azone looks boring—a white powder you’d probably ignore if you saw it outside a surgical mask-filled laboratory. But in the hands of researchers, it changes the rules. It modifies the lipids in the outer layer of skin (the stratum corneum) so drugs can squeeze in more easily. This isn’t about just mixing chemicals; it’s about controlling where medicine goes, at what speed, and how safely it gets there.

Helping Patients With Chronic Conditions

Anyone managing chronic pain or long-term skin problems wants simple, dependable treatments. Here’s where Azone comes in. Topical steroids, hormones, painkillers, and anti-inflammatory drugs don’t always work well on their own. Add a pinch of Azone, and research from Clinical Pharmacology & Therapeutics points to better results. People see faster relief, lower side effects, and more consistent help across stubborn skin patches or inflamed areas.

The real winner? Patients who cannot swallow pills or those who want to avoid stomach upset. Imagine women on hormone therapy or elderly folks needing non-invasive options. For them, Azone technology offers dignity and a break from unnecessary discomfort.

Safety, Regulations, and Honest Conversations

Pharma-grade means Azone meets strict guidelines set by bodies such as the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. Every batch goes through careful screening for contaminants. You want these assurances in your prescriptions because purity impacts your health directly. Worries about toxicity have surfaced, leading to ongoing studies. Current data tell us that low, controlled levels are safe for ordinary use. Oversight only grows tighter as regulators push for more clarity, better labels, and transparent clinical testing.

What Needs Fixing?

Transparency around ingredient sourcing and long-term exposure still doesn’t meet everyone’s expectations. I hear this all the time from patients with sensitive skin or allergies: “What exactly am I putting on my body?” Pharmaceutical companies should listen closely and offer patient-friendly guides. Doctors also need better education about rare sensitivities.

If manufacturers lean harder on data and direct communication, trust in skin-applied treatments will keep rising. Patients get fewer side effects, medical teams enjoy more predictable tools, and makers avoid costly recalls. Honest effort pays real dividends here—both in patient safety and day-to-day care.

Is Azone Powder safe for use in pharmaceutical formulations?

Understanding Azone Powder’s Role

Azone Powder, known to scientists as laurocapram, shows up in plenty of research papers about improving how drugs pass through the skin. In simple terms, it acts as a chemical helper to boost the ability of a medicine to get where it needs to go, especially in creams and patches. Companies often turn to it for its proven record at making certain active ingredients more effective when absorbed by the body’s largest organ—our skin.

What Research Says About Safety

Dig into toxicology reports and you’ll find a pattern: low toxicity and rare side effects at common concentrations. The U.S. Food and Drug Administration (FDA) placed Azone on a list of substances that are generally recognized as safe, but only for external use. International research backs this up. One study published in the journal “Pharmaceutical Research” tracked its use over ten years in experimental skin care products. No patterns of long-term irritation or allergic responses appeared, even among sensitive groups. I remember working in a pharmacy and seeing very few products recall reports involving Azone, which speaks to its safe track record when used as intended.

Potential Risks and Gray Areas

No ingredient checks every safety box, no matter its benefits. Azone Powder’s main risk pops up in higher concentrations: cases of redness, mild inflammation, or a tingling sensation have surfaced in clinical trials using levels well above standard industry practices. European agencies have flagged chronic exposure as an area needing further research, particularly for compromised skin or infant patients. Years ago, a dermatologist I spoke with cautioned against using high-Azone experimental creams on open wounds, pointing out lingering gaps in published research. That conversation has stuck with me, reminding me to look beyond the label and consider who will actually use the product.

Why Oversight Matters

Nobody wants shortcuts in products we rub on our skin, especially when they’re promises to heal or treat illness. The FDA and European Medicines Agency demand rigorous safety and stability data whenever a new drug formulation introduces an absorption enhancer. Manufacturers must prove that Azone won’t trigger allergic responses, break down into unwanted byproducts over time, or collect in the body. The most reputable firms will also test how Azone interacts with other common excipients. That kind of scrutiny keeps bad surprises off pharmacy shelves. Trust grows from sound data and open communication about ingredients. Patients deserve to know if a compound used by their favorite drugmaker measures up to modern safety expectations.

Pathways to Better Assurance

Mistakes and gaps in science don’t have to spell disaster. More transparency in clinical reports, longer-term tracking in diverse patient groups, and clear labeling can bridge the trust gap for consumers. Healthy skepticism from doctors and pharmacists can spark smarter studies. Regulatory agencies should work with industry to tighten limits on concentration in over-the-counter products and alert practitioners to safety updates. My own experience reading patient feedback reinforces the need for plain language on labels—a little education goes a long way.

Azone Powder has earned its spot in many pharmaceutical solutions, but it still deserves the eye of experts and thoughtful questions from those of us who use it.

What is the recommended concentration of Azone Powder in topical applications?

Why Azone Powder Gets Attention in Topicals

Azone Powder, known to scientists as Laurocapram, pops up often in discussions about skin creams and gels. I remember first seeing it listed next to high-powered actives and wondering why such a quiet ingredient gets so much attention from formulators. Azone works behind the scenes, coaxing other ingredients to sink deeper into the skin. Pharmacies and cosmetic labs see it as a game-changer for products that rely on actives reaching the right layer of skin.

The Recommended Range for Azone Powder Concentration

Over the years, I’ve seen a lot of curiosity—and confusion—about how much Azone to include in a topical mixture. Clinical studies and published guidelines usually point to a range between 0.5% and 5% by weight. More frequently, formulators lean towards the lower end, often settling near 1% to 3%. Studies back this up, showing products at 1% perform well for boosting absorption without risking irritation.

Why Too Much Can Backfire

Formulators sometimes get tempted to push the percentage higher, thinking more Azone will put absorption on overdrive. But there’s no free ride. Data from dermatology journals reveal that concentrations above 5% tend to cause redness and stinging, even in people without sensitive skin. Some folks develop dryness or a mild rash when using more than needed. That’s why sticking to tested concentrations matters, especially when making creams for over-the-counter sales.

Benefits and Risks: Walking the Line With Any Additive

Any time I read about an ‘enhancer’ ingredient, memories come back of watching my own skin react to new products. The cool thing about Azone: it helps actives like retinol, vitamin C, or anti-inflammatory extracts penetrate better, potentially making the product work smarter. Dermatologists, including expert panels in journals like Skin Pharmacology and Physiology, routinely highlight this benefit. They also point out the risk—go too high, and the skin’s natural barrier can lose its balance.

Safe Mixing and Sensible Use

Mixing Azone needs caution. I remember one seasoned compounder who always started his creams with 0.5% and moved up only if testing showed no irritation. This stepwise approach allows for safe scaling—the skin gets time to adapt, and individuals can spot warning signs early. Trusted cosmetic brands publish results from patch tests, adding confidence for people who want safety data before they try a new lotion.

Transparent Labeling and Informed Choices

Clear labeling makes a real difference. Back in the day, few products told you exactly how much Azone showed up in the bottle. Current good manufacturing practices call for openness, and reputable brands respond by listing the percentage or at least the full ingredient deck. Anyone with sensitive skin should check those labels and consider patch testing before full use.

Moving Forward With Evidence

Azone Powder’s strong reputation comes from decades of careful study and real-world experience. Science says: keep the concentration low, don’t treat it as a magic solution, and stay aware of skin reactions. Relying on evidence and transparency helps people trust what they put on their skin, and science-backed guidelines support better results for everyone—whether you’re mixing creams in a lab or picking up a tube at the store.

How should Azone Powder BP EP USP Pharma Grade be stored?

Why Focus on Storage?

Strong science and quality control turn raw ingredients into reliable medicine. Azone Powder sits in a special category: it’s used as a penetration enhancer, and its job is to help other drugs pass through the skin more effectively. That task only works if the powder stays pure and stable, so storage decides if a batch lives up to strict standards or not. Experience in pharmaceutical work has shown me there’s never a shortcut when shelf life and quality are on the line. Mishandling can mean months of work end up wasted.

Common Sense and Science in Storage

Many powders, especially those with a BP, EP, or USP grade label, share some basics: air, light, moisture, and temperature play the main roles in whether the material stays the way it should. Azone powder in particular holds up best in a cool, dry room, far from heat sources or any areas with big swings in temperature. Humidity can be a stubborn enemy. Even in a city where the weather stays steady, the room’s climate sometimes drifts out of the safe range during rainy weeks or high summer. A good storage setup uses a dehumidifier, silica gels in the container, or even room air conditioning set on a strict schedule.

Factories don’t store raw materials next to machines pumping out steam or places dealing with open water. The risk of cross-contamination is too high. For Azone Powder, storing near solvents or volatile chemicals invites trouble. One accident or spilled container could ruin a whole batch shelf.

The Right Container Makes a Difference

Not every plastic jar is created equal. The best option for Azone powder is a tightly sealed, opaque container. Glass jars work well since they don’t react with the powder or leach chemicals over time. High-quality containers prevent air from leaking in; a loose lid almost always means you’ll see moisture clumping the powder by the next check.

Personal experience in the lab taught me clear plastic containers age quickly, letting in just enough light to start changing the appearance of sensitive white powders. Azone likes the dark, so placing jars in a closet or dark storage rack adds another layer of protection.

Labeling and Rotation

A clean, visible label showing the product name, batch number, and date of receipt saves confusion down the line. More than once I’ve watched colleagues discover two identical jars where only one stays in-date. Using the oldest batch first—what some call “first in, first out”—keeps waste down and ensures the most stable powder supports the next round of formulation.

Pharmacies and manufacturers keep records on storage temperature, container checks, and inventory. These habits double as insurance against costly errors, and if anything looks off—a change in smell, color, or texture—pulling a batch out of use protects the whole operation.

Room for Improvement

Staff training plays a role here. It’s easy for new hires to overlook a slightly propped lid or leave a container too close to a window. Regular reminders and strong habits pay off, especially during busy production cycles.

Modern storage solutions use digital controls and alarms. Not every lab can afford automatic climate systems, but even low-tech tools—humidity cards, daily checks, locked cabinets—keep the risks manageable.

Getting storage right for Azone Powder comes down to respect for details. Clean containers, steady climate, and careful handling aren’t just best practices. They mean safe and effective products for patients, and fewer headaches for those who work behind the scenes.

What are the compatibility and stability considerations for Azone Powder in formulations?

Understanding Azone Powder’s Role

Azone Powder pops up in a lot of topical and transdermal products, usually because it helps certain ingredients make it through the skin. Its use brings up more than a few questions about how well it gets along with other ingredients, and how long it keeps working as expected. For anyone formulating with Azone, or using a product containing it, there’s a lot more at play than just mixing chemicals together.

Mixing Azone with Other Ingredients

Some folks might think all powders blend the same way, but Azone tells a different story. This ingredient has a knack for improving skin penetration, but it also brings risks of unintended reactions. Some excipients, like certain high-fat bases and highly unsaturated oils, don’t always play nicely with Azone. They can change how Azone interacts with the skin or break it down over time. Pairing Azone with alcohol-based solutions works well, and I’ve noticed that creams using lower water content tend to keep its qualities stable longer.

Azone handles mild acids or non-ionic surfactants with little fuss, though strong oxidizers and a handful of preservatives can trip it up. I’ve seen formulas thicken or even separate when these partners get added. This can mess with the appearance and how the cream or gel goes on, making people less likely to trust or use the product consistently.

Azone’s Stability Over Time

Shelf-life often gets overlooked. Azone won’t last forever, especially if heat or strong light sneaks into the packaging. There’s been research showing Azone degrades faster at higher temperatures. I remember a client who stored samples above room temperature—by six months in, potency had dropped nearly in half. Temperature control can’t be overstated, whether storing bulk powder or finished formula.

Water content is another headache. Azone likes to wander if too much water is present—hydrolysis starts, and the active gets chipped away. Keeping water percentages low, and shielding the product from repeated opening or humidity, goes a long way. Antioxidants sometimes help, but don’t expect miracles if humidity stays high. Pack design makes a difference, too. Opaque, airtight containers slow down breakdown, especially for sensitive forms like gels.

Supporting Azone in the Formula

From what I’ve seen, lab testing and real-world stability studies save plenty of headaches. Involving a skilled chemist often uncovers silent incompatibilities that don’t show up for weeks or months. For businesses, cutting corners on compatibility checks often backfires— failed batches or complaints pile up fast.

Manufacturers do well to tweak formula pH, stay away from unnecessary oxidizing preservatives, and follow industry storage guidelines. Using fresh, well-characterized Azone powder directly from trusted suppliers lowers the chance of early breakdown or contamination.

Improving Results for Everyone

With Azone, what looks simple on paper rarely stays simple inside a bottle. Every ingredient plays a role, and their flow together, or lack of it, impacts not just lab results but a consumer’s experience and safety. Once, a formulation error with Azone led to skin irritation in a small group of product testers. Digging deeper, a reactive preservative was the culprit. Paying attention to known incompatibilities helped us fix the problem, restore confidence, and rethink future formulations.

In short, Azone can be a reliable performer when handled with care— teaming it up with supportive excipients, giving it covers against heat and light, and staying honest about product testing. A well-matched formula protects consumers, supports reputation, and lets Azone do the job it was meant for.

Azone Powder BP EP USP Pharma Grade
Names
Preferred IUPAC name **1-dodecylazacycloheptan-2-one**
Other names laurocapram
Azone
1-dodecylazacycloheptan-2-one
N-dodecylazacycloheptan-2-one
1-laurylazacycloheptan-2-one
Pronunciation /ˈeɪ.zɒn ˈpaʊ.dər ˌbiːˈpiː ˌiːˈpiː ˌjuːˈesˈpiː ˈfɑː.mə ɡreɪd/
Identifiers
CAS Number 136-14-7
Beilstein Reference 3622224
ChEBI CHEBI:90728
ChEMBL CHEMBL1516
ChemSpider 17553
DrugBank DB06750
ECHA InfoCard 03e8e9a7-3a1c-4da9-bd03-07dc70bfe8ac
EC Number EC 246-934-2
Gmelin Reference 93513
KEGG C07087
MeSH D02AE14
PubChem CID 5361045
RTECS number WY2806000
UNII 41K73Q682Z
UN number UN3077
CompTox Dashboard (EPA) DTXSID60940618
Properties
Chemical formula C12H25NOS
Molar mass 282.47 g/mol
Appearance White or almost white crystalline powder
Odor Odorless
Density 0.94 g/cm³
Solubility in water Insoluble in water
log P 3.6
Vapor pressure 0.0025 mmHg at 25°C
Acidity (pKa) 8.8
Basicity (pKb) pKb: 3.6
Magnetic susceptibility (χ) -12.4×10⁻⁶
Refractive index (nD) 1.475
Viscosity Viscosity: 9.0 - 12.0 mPa.s (10% in water at 20°C)
Dipole moment 0.88 D
Thermochemistry
Std enthalpy of combustion (ΔcH⦵298) -393.5 kJ/mol
Pharmacology
ATC code D11AX
Hazards
Main hazards Oxidizing solid, harmful if swallowed, causes skin irritation, causes serious eye irritation, may cause respiratory irritation.
GHS labelling GHS07, GHS08, Warning, H302, H315, H319, H335, H361, P261, P264, P270, P271, P280, P308+P313, P405, P501
Pictograms GHS07
Signal word Warning
Hazard statements H302, H315, H319, H335
Precautionary statements Store in a cool, dry place. Keep container tightly closed. Avoid contact with skin and eyes. Use personal protective equipment as required. Do not breathe dust. Wash hands thoroughly after handling.
NFPA 704 (fire diamond) Health: 2, Flammability: 0, Instability: 0, Special: -
Flash point > 113°C
Autoignition temperature > 230°C
LD50 (median dose) LD50 (median dose): 500 mg/kg (rat oral)
PEL (Permissible) 10 mg/m³
REL (Recommended) 10 mg
Related compounds
Related compounds Azone HCl
Azone Base
Oleyl alcohol
Oleic acid
Isopropyl myristate
Dimethyl sulfoxide (DMSO)
Propylene glycol
Dodecyl 2-(N,N-dimethylamino)acetate
Laurocapram analogs
N-methylpyrrolidone