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Isopropyl Myristate BP EP USP Pharma Grade: A Deep Dive

Historical Development

Long before anyone gave a formal name to isopropyl myristate, people searched for ways to help ingredients get through the tough outer barrier of human skin. By the 1950s, chemists had figured out how to make this ester by reacting myristic acid (from coconut oil or palm kernel oil) with isopropyl alcohol. That marked a turning point for topical pharmaceutical formulations and personal care. Over decades, as more was learned about ingredient interactions and skin absorption, global standards like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) demanded even tighter controls on purity and consistency. Isopropyl myristate’s journey from a simple lab curiosity to a tightly regulated excipient shows just how much demand shapes the development of safe and effective compounds for widespread use.

Product Overview

Isopropyl myristate looks straightforward—a clear, lightly oily liquid with no strong odor and a texture that glides between the fingers. It exists mainly as an emollient and penetration enhancer in pharmaceuticals and cosmetics. Many topical drugs, creams, and lotions depend on it for reliable delivery of active compounds. Its role goes beyond texture; it makes certain medicines actually work by helping them soak into the skin faster. In my work on product development in pharmaceutical settings, I’ve seen how it can mean the difference between sticky, slow-absorbing ointments and smooth, comfortable ones that get prescribed again and again.

Physical & Chemical Properties

Every batch brings slightly different values, but pharma-grade isopropyl myristate holds a consistent boiling point around 167°C at 10 mmHg and a melting point below room temperature, so it stays liquid and mobile. Its low viscosity gives compounded creams that elusive silky slip. With a molecular formula of C17H34O2, a molar mass of 270.45 g/mol, and a specific gravity hovering near 0.85–0.87 at 25°C, manufacturers find it easy to process and blend. It resists hydrolysis in storage—an advantage in humid climates where water-sensitive excipients often break down. Its refractive index sits in the 1.434–1.438 range. For processors and formulators, these numbers are more than trivia—they control everything from solubility profiles to packaging choices.

Technical Specifications & Labeling

Each region sets benchmarks: BP, EP, and USP standards measure purity level, levels of contaminants like heavy metals, absence of peroxide, and proper identification via infrared spectroscopy or gas chromatography. Labels must spell out these compliance marks, batch numbers, production dates, and recommended storage, since even slight deviations can tank a product’s shelf life or safety profile. It isn’t just bureaucratic fuss—the outcome has direct impact on patients applying a prescribed cream or a child using over-the-counter lotions. Accurate, transparent labeling gives both prescribers and users a clear sense of what’s in the bottle, and backs up pharmacovigilance if things ever go wrong.

Preparation Method

The synthesis looks simple but needs precision. Producers take high-purity myristic acid—usually from plant oil hydrolysis—and react it with isopropyl alcohol in the presence of a strong acid catalyst like sulfuric acid. The esterification cooks under vacuum to pull off water and push the reaction forward. Afterwards, the mixture requires multiple washes and distillations to strip out any leftovers: unreacted acid, water, and catalyst traces. These post-reaction purifications sharply distinguish pharma-grade product from technical grade. Regulatory audits typically hone in on preparation records and washing logs since even small contaminants influence patient health.

Chemical Reactions & Modifications

Isopropyl myristate can hydrolyze back into isopropyl alcohol and myristic acid if exposed to moisture and certain enzymes, especially on the skin. In pharmaceutical research, this trait is a double-edged sword: controlled hydrolysis can release active ingredients, but uncontrolled breakdown causes changes in product look, smell, and even safety. Chemists sometimes modify its structure, swapping in other alcohols or acids for custom effects—say, slower absorption or different sensory touch—for niche skin delivery systems. These derivatives rarely make it to broad pharma use, but the flexibility sparks new ideas in formulation research.

Synonyms & Product Names

Working with different suppliers and regions, I’ve seen isopropyl myristate called by a dozen names: IPM, Isopropyl Tetradecanoate, Propan-2-yl myristate, Myristic acid isopropyl ester, and CAS No. 110-27-0. Trade names sometimes crop up, especially with specialty distributors, but in regulated supply chains, the formal chemical names drive procurement and quality checks. Being alert to these synonyms matters in global development, where raw material sourcing needs to avoid costly mix-ups and regulatory delays.

Safety & Operational Standards

Handling pure isopropyl myristate means tracking flammability risks, as flash points can fall between 150 and 170°C. I’ve seen manufacturing floors designed with special ventilation to keep vapors under control, since inhaling high concentrations irritates the respiratory tract. Globally harmonized SDS (Safety Data Sheets) outline safety gear—usually gloves, goggles, and good local exhaust. From a toxicity standpoint, acute oral and dermal exposure shows low hazard in animal models, which suits its cosmetic and topical use. Chronic exposure reviews can flag mild skin irritation, so finished products—especially for people with eczema or compromised barriers—undergo extra dermatological judgment for concentrations and exposure frequency.

Application Area

Pharmaceutical compounding, topical analgesics, antifungals, corticosteroid creams, and even certain injectables rely on isopropyl myristate to boost skin absorption. Over-the-counter, the excipient crops up in moisturizers, makeup removers, bath oils, and deodorants because it thins out greasier oils and absorbs fast, leaving less shine. My work with contract manufacturers has shown that even food-grade production floors seldom match the cleanliness of pharma-grade lines, so choosing the right grade for the job never becomes a box-ticking exercise. In microencapsulation, IPM acts as a carrier for oil-sensitive actives, creating stable delivery systems for vitamins or herbal extracts that would break down in water-based gels. Veterinary and pet-care products sometimes use IPM for topical flea medications or skin barrier creams, given its similar safety margin across mammalian species.

Research & Development

Active pharmaceutical ingredient (API) formulation labs spend much time optimizing excipient blends for new deliveries, and isopropyl myristate usually features in those early screens for transdermal and dermal applications. Research over the last decade has probed combinations of IPM with other esters, silicones, and lipid-phase enhancers, searching for the sweet spot in balance between penetration and irritation. Analytical chemists running HPLC (high-performance liquid chromatography) testing for IPM validate methods to nail down per-batch content and track potential degradation products. Green chemistry efforts drive exploration of alternative synthesis routes using less energy or recovering more byproducts. Every time major journals publish a new penetration study or dermatokinetic profile on IPM, formulation teams line up new trials, chasing performance gains for both drug and cosmetic launches.

Toxicity Research

Most toxicological evaluations have shown isopropyl myristate as safe for use in topical and even ocular formulations, provided concentration remains within defined limits. Studies highlight low systemic absorption, with the majority remaining in the epidermal layers or being metabolized on first contact. Animal model tests show high LD50 values (acute toxicity), so risk of poisoning when used as intended looks remote. Observed irritancy—mainly in repeated or high-concentration exposure—nudges regulators to recommend patch testing for novel formulations and extra caution with sensitive populations. Recent research tracks possible interactions with compromised barriers (such as burned or eczematous skin), aiming to stop fast absorption of other, less benign compounds piggybacking in IPM’s wake.

Future Prospects

Therapeutic innovation never stands still, and isopropyl myristate’s future centers on new drug delivery challenges. As more actives demand reliable, non-invasive pathways through the skin, especially for chronic disease patches and hormone therapy, refined esters and blends will keep drawing R&D dollars. Regulatory reevaluation—driven by consumer safety groups and new digital traceability standards—pushes suppliers toward cleaner, greener synthesis, perhaps using enzyme catalysis or waste minimization. Anticipated advances in personalized medicine may call for custom blends of emollients, where isopropyl myristate’s role adjusts to match each patient or product type. Researchers track every small tweak in structure, blend partner, or purity as a new path to safer, more effective treatments and cosmetic experiences.




What is Isopropyl Myristate BP EP USP Pharma Grade used for?

The Role of Isopropyl Myristate in Pharmaceuticals

Isopropyl myristate, recognized by its pharma grade certifications (BP, EP, USP), earns a reputation as a workhorse in the pharmaceutical world. In creams, lotions, and topical medications, it steps up as a skin absorption enhancer. This matters because some medicines need more than just surface contact. If a patient uses an ointment for pain relief or a dermatological issue, the active ingredients must travel through the tough outer layer of skin. Isopropyl myristate provides that boost, helping drugs reach their target so that patients see results faster.

What Makes It Useful?

The unique structure of isopropyl myristate gives it the ability to mix easily with skin oils. It melts into the skin instead of sitting on top like many other substances. That matters for real-life comfort. Nobody wants to feel greasy or sticky after applying a cream. This quality makes isopropyl myristate a go-to for formulating products people actually want to use.

Another advantage: it promotes the delivery of both medicines and nutrients, carrying them below the surface. I’ve seen many people turn away from helpful products because of a heavy, lingering feel. Adding isopropyl myristate often makes the texture lighter, solving two issues at once—efficacy and user satisfaction.

Beyond Topical Medications

This compound shows up beyond just topical medicines. In capsules and soft gels, its oil-like nature helps dissolve ingredients that do not play well with water. Certain vitamins, for example, perform better when carried in a lipid-based solution. Isopropyl myristate steps into this role. It consistently proves reliable in dissolving fat-soluble substances and making sure they stay stable until the patient takes them.

In the world of drug manufacturing, stability means safety. The pharma grade status—compliance with BP, EP, and USP—shows producers have met demanding international quality rules and safety standards. These certifications do not come easy. Reputable manufacturers scrutinize each production step, ensuring contaminants stay away and product consistency meets strict requirements batch after batch.

Risks and Solutions

Isopropyl myristate enjoys a long-standing record for safety, but there are some considerations. Rare cases of skin irritation or allergies do crop up, especially in those with sensitive skin or with repeated use. Any ingredient in pharmaceutical use must be tested for every possible reaction. People can talk to pharmacists or dermatologists about alternatives if sensitivity shows up.

Environmental impact also deserves a look. Production and disposal of chemicals draw attention from regulators and advocacy groups as everyone looks for cleaner ways of making and using pharmaceuticals. Some manufacturers have started to prioritize greener synthesis and recycling programs to address these concerns.

Looking Ahead

Understanding ingredients like isopropyl myristate in medicine and skincare builds trust. Information empowers patients to make informed choices, and it nudges the industry to keep pushing for higher standards. Pharmaceutical companies can always do more to listen to user feedback, focus on sustainability, and drive safety data collection. In my own work, I see that patient voices and transparency add value beyond just meeting standards—they become cornerstones for real progress.

Is Isopropyl Myristate safe for use in pharmaceuticals and cosmetics?

Everyday Encounters

Most people have already used products with isopropyl myristate without thinking twice about it. Creams, lotions, topical medicines, even some makeup removers—plenty of these have this ingredient mixed in. It makes creams feel smoother and less greasy, which no one seems to mind. Few stop to ask what happens beyond that silky finish.

Behind the Label

Isopropyl myristate is a synthetic oil, made from isopropyl alcohol and myristic acid (from coconut or palm oil). It works as an emollient, helping skin feel soft. In pharmaceuticals, it acts as a helper for the main medicine, making sure it gets through the skin layers better—think of pain-relieving gels or medicated patches.

Safety Record and Research

Safety data on isopropyl myristate runs deep. The Cosmetic Ingredient Review, a respected scientific panel, evaluated studies going back decades. They found that when used the way most products do, this ingredient rarely causes trouble for the average person. In spot tests, the chances of irritated skin seemed low—about as rare as other common emollients in skincare. The U.S. Food and Drug Administration includes it on lists of compounds allowed in over-the-counter skin products.

On the other hand, those with sensitive or acne-prone skin might want to watch the ingredient list. Research links isopropyl myristate to breakouts in people who already battle clogged pores. Studies suggest it can make skin feel slightly oilier and that it might worsen blackheads for some. I know people who notice a rash when they switch to a new hand lotion with this stuff.

Risks: Understanding the Context

Safety always ties back to how much is in the product, and how it is used. Swallowing pure isopropyl myristate or rubbing it into open wounds at high concentrations isn’t a good idea and isn't how it's meant to be used. The amounts in finished lotions or medicated creams haven't shown toxic effects in humans when applied to clean skin as directed. Animal testing in excessive doses pointed to problems, but the industry uses far smaller concentrations.

Another concern: allergies. Any ingredient can cause itchiness or redness if the person has an allergy or sensitivity. Dermatologists usually recommend testing a small spot if someone knows they have very reactive skin.

Supporting Safe Use

Product makers should keep following the latest evidence and adjust formulations if there are credible warnings. I’ve noticed more products highlighting “non-comedogenic” on the label, meaning they skip or limit ingredients like isopropyl myristate that can worsen acne. People with frequent breakouts often hunt for those labels.

For folks with allergies or sensitive skin, knowledge is power. Checking ingredient lists and talking with a health professional before switching creams can prevent unpleasant surprises. Doctors, pharmacists, and skincare experts have a role in helping users spot patterns between ingredients and problems.

Looking Ahead

Isopropyl myristate will probably remain in countless products for the foreseeable future. It’s earned a reputation for being safe in typical doses. Paying attention to emerging research will help stop trouble before it starts. Sharing honest stories—both good and bad—helps others make smarter decisions with what they put on their skin.

What are the main specifications and purity standards for Isopropyl Myristate BP EP USP Pharma Grade?

The Role of Isopropyl Myristate in Pharmaceuticals

Isopropyl myristate helps a lot in making topical drugs easier to use. I’ve seen it turn sticky ointments into smooth, non-greasy creams. This ester of isopropyl alcohol and myristic acid works as much more than just a softener. Drug manufacturers trust it for enhancing skin absorption in everything from corticosteroid creams to moisturizing lotions you’d find at a corner store.

Main Specifications for BP, EP, and USP Grades

When a pharma company needs isopropyl myristate, purity isn’t a luxury—it’s the law. The British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) each lay out what must pass for pharmaceutical grade. I’ve seen the confusion when these specs aren’t met: rejected batches, wasted money, and a scramble to fix paperwork.

  • Identification: Labs confirm it by checking its infrared absorption and chemical makeup—no shortcuts. It’s all about certainty: has to be isopropyl myristate, nothing else.
  • Purity: BP/EP/USP rules put purity at a near-perfect 98.0%–102.0%, measured against the molecular standard. Even a small drift outside that range can push a manufacturer to destroy a batch rather than risk contamination or instability down the line.
  • Acid Value: I’ve watched teams check this with simple titration. Numbers must usually fall below 0.5 mg KOH/g. Higher acidity hints at chemical breakdown and could affect skin compatibility—an easy way to invite complaints.
  • Water Content: Less than 0.2% by weight, usually by Karl Fischer titration. More water means hydrolysis risk, mold, and a shorter shelf life for finished drugs. Keeping water out isn’t just about storage—it points to strong manufacturing discipline.
  • Specific Gravity: This old-school test checks density. Pharma-grade IPM typically scores between 0.850 and 0.855 at 20°C, according to the books.
  • Refractive Index: The value should fall within 1.434–1.438 at 20°C, proving chemical purity and process consistency with a quick lab test.
  • Color: Clear and colorless describes top-quality IPM. Yellow or cloudy means something went wrong—think oxidized or degraded product, both big red flags.
  • Heavy Metals and Impurities: Less than 10 ppm of heavy metals. Anything higher is a safety risk and guarantees falling short of regulatory approval.

Why Quality Standards Protect Both Business and Patients

Sloppy quality checks cost more than people expect. Product recalls damage more than profit—they ruin trust, something I’ve seen take years to rebuild once a reputation slips. The authorities expect a strict trace from every drum of isopropyl myristate back to raw material suppliers. No shortcuts or loose ends. In fact, industry best practices push for even tighter specs than the official minimums, just to play it safe.

Raising the Bar On Purity

Better testing means fewer surprises. Many leading manufacturers use advanced chromatography to catch even the tiniest levels of potential contaminants. This doesn’t just meet BP, EP, or USP rules; it reassures buyers, hospitals, and pharmacies that the product won’t cause unexpected reactions. There are still challenges—especially sourcing certified raw materials and maintaining spotless production lines in bulk—yet every extra hour of testing saves headaches down the road.

Building Stronger Pharma Supply Chains

Demand for safe, consistent excipients keeps rising. I’ve seen supply chains stumble when a source overseas drops standards or paperwork is missing. Companies now double down on supplier audits and real-time quality tracking. It’s not about overkill—regulators insist on it, and rightly so. Process improvements—like using sealed storage, better filtration, and upgraded purification steps—help keep every keg in spec, even when demand surges.

Looking Forward

Every pharma ingredient must earn its place by meeting tough standards. Isopropyl myristate is no different. As innovation pushes the line on new formulations, quality expectations follow. Patients and practitioners both want drugs they can trust—right down to the last molecule in a bottle of skin cream.

How should Isopropyl Myristate BP EP USP Pharma Grade be stored and handled?

Why Care About Storage?

I once saw a pharmaceutical facility face a real headache because someone overlooked the basics of storing pharmaceutical ingredients. Costs went up from wasted batches, staff spent days sorting through the contamination, and timelines got thrown out the window. That’s all avoidable with the right approach, especially for something as commonly used as isopropyl myristate—a compound found in everything from topical creams to makeup removers. If stored and handled without enough attention, this clear, oily liquid can turn from reliable to risky.

Keep It Cool, Dry, and Sealed

Isopropyl myristate reacts with moisture and likes to attract water from the surrounding environment. Letting in humidity corrodes purity, which is a fast track to failed quality checks. I’ve seen drums stored near loading docks get exposed to the summer air, leading to cloudiness, off-smells, and lab rejections. Best practice: keep the drum in a climate-controlled space, away from direct sunlight and anywhere that gets hot or damp. A good target for storage hovers around 15°C to 25°C, with humidity kept low. Always close containers tightly after use—loose lids have sunk more than one production run.

Using the Right Containers

Metal or HDPE drums offer the right protection. Avoid soft plastics or thin bags; the liquid will seep through or react with them. I always double-check the seal and integrity before rolling a drum into the production workroom. If your supply arrives in small, opaque bottles, keep those away from sources of heat or sparks. Fire is a real concern; isopropyl myristate is combustible. A single lapse in judgment—like leaving an open bottle near a running motor or space heater—can trigger a major incident.

Clean Tools and Careful Transfers

Equipment used for transfer makes a difference. Dedicated stainless steel or food-grade pumps work best, since residue from other ingredients will taint the batch. Every new transfer should start with tools that are dry and free from detergent or cleaning agents. Cross-contamination sneaks in quietly, and by the time it gets picked up in QC, money and time are lost. I always stress to new team members that it’s easier to spend five minutes cleaning than fix a ten-hour mistake.

Safety First—For Everyone

It’s tempting to treat isopropyl myristate as harmless, since it doesn’t look or smell dangerous, but skin irritation and lung discomfort can set in if you get too casual. I always make it a point to use gloves, goggles, and lab coats, even during quick pouring. Ventilation matters: keep those exhaust fans running, because vapors can build up quickly, especially in smaller rooms. Safety showers and eye wash stations should stand within reach for any spills or splashes. It’s not about being dramatic—one splash to the eye convinced me that shortcuts don’t pay off.

Waste Management Counts

Disposing of leftover isopropyl myristate should always follow regional regulations. Don’t pour it down the drain or toss it out with regular trash. In my experience, partnering with a certified waste handler saves time and shields the company from compliance disasters. Records for each disposal step help later if questions come from inspectors. Staying on top of documentation builds trust with regulators, which always pays off in the long run.

Prevent Problems Before They Start

I’ve learned that investing in training—and repeating the right procedures often—keeps people and products safe. Posting clear storage instructions and emergency contacts on the storage room wall acts as a simple, cost-effective reminder for everyone, especially in high-pressure moments. Pharma-grade ingredients always deserve this level of respect, and a steady routine makes good outcomes possible, every single day.

Can Isopropyl Myristate BP EP USP Pharma Grade be used in food or oral products?

Looking Past the Pharma Label

People in manufacturing and R&D sometimes ask whether Isopropyl Myristate (IPM)—a common skincare ingredient—fits anywhere in food or oral care. You find IPM marked as BP, EP, or USP grade—the signs of strict pharmaceutical benchmarks. But these standards focus on medicinal reliability, not whether IPM belongs anywhere near our mouths or plates.

Breaking Down What IPM Is and What It Does

IPM comes from isopropyl alcohol and myristic acid, usually from plant or animal fats. My first real encounter with it was during a product development stint in a dermaceutical lab. The team loved its silky slip in creams and gels. IPM dissolves oil-soluble things well, softens skin, and makes lotions glide. It’s part of why after-shave and hair conditioners feel smooth instead of sticky.

Chemically, it does an excellent job reducing greasy texture and helping medications spread across skin without locking in moisture too tight, which might trap bacteria. For all its benefits in topical products, IPM wasn’t ever considered edible or safe for chewing gum or candies. It simply wasn’t designed for that route.

Safety and Regulatory Status

Any ingredient touching the inside of our bodies faces stricter hurdles. I checked the US FDA’s Generally Recognized as Safe (GRAS) list, which covers substances for food use. IPM sits outside these lines. European food safety authorities have not cleared it either.

Testing for pharma applications measures purity—how much of the batch remains uncontaminated by toxins, heavy metals, or leftover starting materials. That doesn’t mean regulators ran safety studies for ingestion or oral exposure. No credible food-grade specifications exist for IPM, and I haven’t seen industry insiders call for them either. That stands out, since plenty of multipurpose molecules (like glycerin) work safely across cosmetics, food, and pharma because they earned that trust through decades of monitoring.

Potential Risks with Oral or Food Use

IPM absorbs through skin, but our digestive tracts don’t process chemicals the same way. If consumed, IPM can cause nausea and stomach upset. Toxicology reviews, like the one published by the International Journal of Toxicology, show that even in animals, high doses in the gut led to gut lining irritation and swelling. No food or oral care company takes on the liability of using an ingredient that hasn’t cleared basic ingestion safety.

Even in pharmaceuticals, IPM gets restricted to topical forms. In the world of toothpaste and mouthwash, the emphasis steers toward things proven safe to swallow in tiny amounts over months or years, like sorbitol, xylitol, or flavor oils.

Seeking Alternatives and Solutions

If your company needs a texture enhancer or solubilizer for food or oral applications, safer options exist. Glycerin, propylene glycol, PEGs, and certain food-grade esters meet stringent regulatory checks for consumption. Skipping IPM and sticking to those well-vetted ingredients not only avoids legal headaches—it brings peace of mind.

It’s tempting to grab multi-use ingredients for manufacturing convenience. But sourcing matters. I learned long ago in production that regulatory compliance solves a lot more future problems than clever substitutions ever will.

IPM has a well-earned role in skincare and pharma topicals. But it should never end up on your fork or toothbrush.

Isopropyl Myristate BP EP USP Pharma Grade
Hazards
Lethal dose or concentration LD50 (oral, rat): > 5,000 mg/kg