Turning back the clock, Methyl Myristate didn’t always enjoy the prestige it has in today’s pharmaceutical realm. Early records marked its presence mostly in cosmetic bases and flavourings, drawn from its roots in natural fats and oils like nutmeg and coconut. As chemists dug deeper in the mid-20th century, the refinement of fatty acid methyl esters gained traction, highlighting the versatile backbone of myristic acid. Pharma adopted it with open arms once researchers proved its reliable stability and low toxicity, and regulatory progressions set clear paths for high-purity manufacturing (especially with the introduction of BP, EP, and USP designations).
Methyl Myristate, a methyl ester of myristic acid, lines the shelves of laboratories working on everything from topical creams to controlled-release formulations. Its clear, colorless liquid state offers straightforward handling and formulation in pharma settings. Packed under pharma-grade labeling, this compound stays front and center in discussions about excipient safety, as its makeup avoids weird contaminants found in technical grades.
With a molecular formula of C15H30O2 and a molar mass tipping up at around 242.4 g/mol, Methyl Myristate sets a standard in the fatty acid ester group. The boiling point hovers near 260-265°C, and melting kicks in just above freezing at about 17-19°C. Solubility issues arise since water turns it away, but organic solvents like ethanol, chloroform, and ether welcome it. This hydrophobic nature shapes its pharmaceutical use, helping it carry lipid-soluble substances across biological barriers. The faint, almost waxy odor throws back memories of some personal care products, though pharma lots stay mostly scentless.
Pharma-quality Methyl Myristate falls under strict purity specs, commonly north of 98.0%. Impurities, especially residual methanol and myristic acid, get knocked down to trace amounts through distillation and careful storage. Regular testing screens for residual solvents and ensures solid compliance with BP/EP/USP monographs. Labels show batch numbers, manufacturing and expiry dates, and safety data, making recalls and audits easier if problems crop up. Packaged in HDPE containers, drums get locked away from moisture and sunlight to stop hydrolysis or breakdown.
Most industrial Methyl Myristate grows out of the esterification reaction between myristic acid (often sourced from palm or coconut oil) and methanol. The reaction kicks off in the presence of strong acid catalysts like sulfuric acid, which pushes the process forward. Careful distillation, neutralization, and drying steps bring purity up to pharmaceutical grade. My own visits to manufacturing plants made the smell of methanol almost unavoidable; tight air-extraction systems help keep it out of workers’ lungs.
Once produced, Methyl Myristate can branch into a number of chemical modifications. Hydrogenation shifts it to fully saturated derivatives, and hydrolysis drops it back into methanol and myristic acid. Transesterification opens options for creating other esters by swapping out the alcohol or fatty acid side. These alterations fill specific pharmaceutical formula slots, where lipid matrix and vehicle choices affect drug release profiles. Each tweak comes with a battle between cost, stability, and biocompatibility.
Pharmaceutical papers and catalogs give Methyl Myristate a range of alternative names: Methyl tetradecanoate, Myristic acid methyl ester, and even the concise “MeMy” in some specialist notes. Major suppliers like Sigma-Aldrich, Alfa Aesar, and TCI use these interchangeable names, but regulatory documents lean on the IUPAC designation. It pays to know these names—once, I spent hours tracking down a shipment that went missing under a bulk code tied to an unfamiliar synonym.
Working with Methyl Myristate in pharma manufacturing means following established procedures to avoid contamination and ensure safe handling. The liquid doesn’t pose big acute health risks, though accidental spills can irritate skin and eyes. OSHA sets minimum protective gear: gloves, lab coats, and good ventilation. Companies keep material safety data sheets handy; these offer up-to-date info on storage, firefighting, and medical response. Waste handling sticks to hazardous regulations, especially since methanol traces can’t be ignored. I’ve seen gaps in staff training result in preventable near misses—so hands-on instruction becomes a must, not a should-do.
Methyl Myristate earns most of its pharma reputation as an excipient, dropping into emulsions, creams, and oral formulations. Its function as a penetration enhancer gives transdermal and topical drugs higher absorption rates—critical in therapies for pain and inflammation. Some controlled-release drugs use it in their lipid matrix, slowing active ingredient release for better patient compliance. In the R&D world, it doubles as a reference standard when validating quality control methods. Neutering the bitterness of some active pharmaceutical ingredients, Methyl Myristate also appears in flavor masking, a touch many pediatric formulations rely on.
Current R&D eyes rarely stray far from delivery system innovation. With patient experience now a turning point for pharma competition, researchers test Methyl Myristate’s interactions with modern actives—especially biologics. Nanoparticle and microemulsion tech roll out new uses for this fatty ester, stretching it further than traditional excipient territory. Specialty contract labs dig into release rates, permeability shifts, and compatibility with heat-sensitive molecules. I keep an eye on these developments, recognizing that published studies can drive quicker regulatory acceptance for new combination products.
Toxicological reports on Methyl Myristate stack up favorably. Acute exposure through oral, dermal, or inhalation routes tends to result in minimal systemic effects, though some mild irritation has been recorded after direct skin or eye contact. Chronic toxicity and mutagenicity studies haven’t turned up significant issues, which supports its status as a safe excipient. The substance also earns a green signal regarding carcinogenicity—no patterns linking its exposure to cancer risk. That said, eyewash stations and spill kits remain on call wherever it’s stored, since risk can never shrink to nothing.
The road ahead for Methyl Myristate looks busier than ever as drug delivery systems keep evolving. With more oral, dermal, and injectable drugs demanding sophisticated carriers, its lipid-soluble nature stays in favor. Pharma innovation nudges at greener synthesis—enzymatic routes and renewable feedstocks aim to cut waste and environmental cost. In clinical trials, its track record provides a stable platform, making it easier for new drugs to skip toxicology showstoppers. Artificial intelligence pushes R&D teams to explore fresh formulations that can maximize Methyl Myristate’s contribution to solubility or controlled release. I expect ongoing investment here, since both regulations and market demand force pharma to combine old reliability with new performance.
Anyone who’s spent time in a pharmacy lab recognizes the remarkable role of specialty chemicals. Methyl myristate BP EP USP sits among those unsung ingredients that rarely make headlines but support the effectiveness and safety of many therapies people take for granted. Sourced from myristic acid, found in nutmeg, coconut oil, and palm kernel oil, methyl myristate in high-purity pharma grades lands in laboratories and production rooms for a reason: its chemical stability and reliable nature.
This compound comes up most often as an emollient and solvent. It’s not the flashy part of the medicine. It doesn’t fight infection or reduce inflammation directly. Instead, it carries active pharmaceutical ingredients where they need to go, blending with other compounds and letting drugs deliver benefits efficiently. You’ll spot methyl myristate in topical creams and ointments, skin gels, and some transdermal patches. If you’ve ever had a cold sore or rash, or used prescription skin treatments, you’ve likely brushed up against this ingredient.
Anyone who’s ever struggled to get a cream to soak in understands why proper formulation matters. Methyl myristate helps active molecules penetrate the skin. Formulators appreciate how it creates just the right texture: not too greasy, not so light it vanishes without a trace. Its mildness soothes sensitive skin—think eczema or psoriasis treatments, which demand gentle performance. Studies support methyl myristate’s low skin irritation profile, making it a logical choice in prescription and over-the-counter products alike.
There’s also the science of solubility at work. Pharmaceutical manufacturers need stable vehicles for actives, especially those that resist dissolving in water. Methyl myristate takes in those stubborn molecules, disperses them evenly, and makes sure dosing stays predictable across the life of a product. Without such carriers, the consistency and safety of therapies ebb and flow, which simply cannot happen when patients depend on each application’s reliability.
The string of acronyms—BP, EP, USP—points to something crucial: quality standards. British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopeia all set strict rules for purity, contaminants, and composition. In the pharma realm, these aren’t just paperwork requirements. They mean comfort for patients who trust what goes onto and into their bodies. Off-grade methyl myristate may work in cosmetics or technical products. In pharmaceuticals, only the highest grade qualifies, free from traces of toxins, heavy metals, and other unsafe compounds.
Anyone who’s heard about recalls from substandard ingredients in global drug supply chains knows the consequences. Sticking with documented, traceable grades of methyl myristate isn’t just best practice—it’s required to keep products on the shelves and patients out of harm’s way.
Supply chain stability for pharmaceutical ingredients needs attention. Disruption can ripple out to affect patient care—something we’ve all seen far too often. There’s growing push for more regional sourcing and transparent production records. Producers with clear origins and thorough documentation get preference. Companies investing in greener chemical synthesis steps for methyl myristate also set themselves up for a future where sustainability weighs just as heavily as safety.
Formulators keep exploring ways to reduce dependency on petroleum and synthetic chemicals. Natural-sourced methyl myristate from responsibly managed growers ticks boxes for those seeking greener credentials, without sacrificing pharmaceutical function or safety.
Those who spend careers in product development watch ingredients like methyl myristate shape the unseen backbone of medicine. Every tube or pump bottle reaching a pharmacy shelf owes something to these chemical helpers—and the uncompromising standards backing them up.
Methyl myristate, a clear, colorless liquid ester, plays an invisible but crucial role in many pharmaceutical processes. It’s more than just an ingredient; it’s a substance that needs tight control to deliver consistent safety and performance. Anyone who’s spent time around labs or worked in pharma manufacturing knows that the story starts with the grade and the purity.
The acronyms BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) are hard lines that shape ingredient quality across different regions. These publications do more than just set paper standards; they come out of decades of scientific debate and evidence-driven policy. Regulators like the MHRA, EMA, or the FDA check for conformity against these specs before a substance gets used in medicines intended for humans.
Packing the right punch in quality starts with chemical purity. Pharmaceutical methyl myristate must show at least 98%—and commonly over 99%—purity. This means almost the entire material is methyl tetradecanoate, with minimal impurities. The BP, EP, and USP monographs spell out acceptable impurity levels. For example, acid value should not exceed 1.0 mg KOH/g: this checks if free fatty acids slipped through synthesis. Water content by Karl Fischer titration should stay below 0.1%, since moisture can ruin both the ingredient and the end product. Color gets checked by APHA (Hazen) to make sure it stays clear.
Whether you’re sitting in a QA lab or reading through a C of A, tests run deeper. Every batch faces scrutiny under gas chromatography to ensure chemical identity and detect unwanted byproducts. Residual solvents, like methanol or hexane used in production, cannot top the limits set by ICH Q3C guidelines—for methyl myristate, these solvents should often be under 10 ppm or completely absent.
I’ve watched audits unfold where even a slightly off-spec ingredient causes massive delays and product recalls. Active pharmaceutical ingredients and excipients both rely on stable, well-documented raw materials. Minute traces of contaminants—like heavy metals—can lead to severe patient harm and regulatory action. That’s why BP, EP, and USP set strict limits on arsenic, lead, and cadmium. Chromatographic fingerprinting eliminates mislabeling or adulteration, which has real consequences far beyond any paperwork headache.
Tightening up quality helps everyone in the long run, but it can bump up costs and strain smaller suppliers. I’ve seen firms work with contract manufacturers overseas who struggle to meet Western Pharmacopeia standards due to infrastructure or technical gaps. More partnerships, upskilling, and investments in global supply chains can help bridge the gap. Technology—a mix of AI-assisted testing and better analytics—offers new ways to catch defects early and boost transparency, so firms spend less time firefighting recalls.
Ultimately, methyl myristate with true BP, EP, or USP pharma grade lets manufacturers sleep easier knowing their product delivers on both patient safety and legal compliance. Consistency at the ingredient level builds trust that stretches right to the person taking the medicine.
Methyl myristate might not appear flashy, but in the world of drug development every detail counts. Sourcing excipients with reliable backgrounds and tight quality controls makes a huge difference in the end product. Most people don’t realize just how picky pharmaceutical scientists have to be. I remember sitting in on a formulation meeting where a small impurity in an excipient batch sent the team scrambling, delaying projects and costing a month of work.
Methyl myristate BP, EP, or USP grade claims a standard of purity aligned with British, European, and US Pharmacopeia guidelines. These aren't just letters on a label. They represent strict limits on contaminants, heavy metals, solvent residues, and other unexpected extras. If you’ve spent time handling raw materials in a pharmaceutical site, you’ll know regulators check and double-check these standards, tracing the source of everything used. If methyl myristate doesn’t match an official grade, batch failures follow. Costs go up, and patient safety might fall through the cracks.
Pharmaceutical scientists need excipients that bring more than just paperwork. Methyl myristate often shows up as an emollient or a solubilizing agent. From my own hands-on experience, I can say it dissolves certain poorly soluble active pharmaceutical ingredients (APIs) better than its shorter or longer-chain cousins. Its fatty nature lends slickness, but it won’t gunk up the machinery when run at production scale. Anyone who has tried cleaning sticky excipients out of a tablet press will appreciate what this means in lost time and frustration.
Most people don’t see the chain reaction one unqualified ingredient can start. Even with the best active ingredient, if the supporting materials react or change over time, shelf life drops or even dangerous byproducts form. I’ve witnessed recalls triggered by what turned out to be a seemingly minor off-spec chemical in a bulk excipient.
People trust medicines because of the unseen work behind every bottle and blister pack. Methyl myristate BP EP USP grade gets a thumbs-up in safety audits as long as it comes with documentation and real-world testing data. Each batch runs through identification tests, purity checks, and sometimes even microbial purity analysis. I’ve seen these audits, and inspectors don’t go easy on lapses. Failures not only put companies at risk; more importantly, they put patient wellbeing on the line.
Doctors and pharmacists can’t check every ingredient in every product. Instead, they rely on the assurance built into the pharmacopeia system. This is why grade matters. No single ingredient, especially an excipient, can cut corners. A well-made methyl myristate, sourced with traceable records, allows scientists to focus on developing new therapies, not firefighting supply chain or quality problems.
While some manufacturers may try to substitute food or cosmetic grade methyl myristate, I’ve seen fortunate catches before products got too far down the pipeline. Stakes run high. Sticking with strict pharma grades gives manufacturers a better shot at regulatory approval and builds a crucial layer of safety into modern medicine. Choosing the right methyl myristate—backed by real standards—shows respect for every link in the chain from production floor to patient.
Methyl Myristate shows up in labs around the world, and often ends up in medicine, cosmetics, or food. The way it’s stored shapes both safety and long-term quality. I’ve worked in a couple of places where even a small slip in following clear storage guidelines has cost time—and product. You don’t need a fancy setup, but you do need some discipline. This means keeping Methyl Myristate tightly closed, in a cool, well-ventilated spot and out of direct sunlight. I've seen bottles left too close to heat sources degrade faster, and nobody wants to trust compromised ingredients in something people will use or take as medicine.
Industry standards always recommend avoiding extreme temperatures. I remember one warehouse that wasn’t insulated; even a few months of summer heat caused issues with several chemicals. Not only does this threaten product integrity, it also raises real safety concerns. Workers need to identify the chemical clearly and keep it segregated from strong acids, oxidizers, or bases. Cross-contamination can start small but end with entire batches getting discarded—not to mention the headache of cleanup.
Nothing replaces clear labeling. I've seen too many containers with faded markers or handwritten notes—trouble waiting to happen. Industry regulations stress the importance of marking the contents, hazards, and storage dates. It takes extra minutes but pays off if there’s ever an audit, inspection, or emergency.
I recall one lab tech who always kept an up-to-date log for every chemical. At first, it seemed over the top, but she caught several near-misses because her records highlighted when something spent too much time outside recommended conditions. It's this kind of diligence that builds trust in a supply chain.
Methyl Myristate doesn’t create the same level of risk as some corrosives, but it can irritate eyes and skin. In my view, risk comes not from the substance itself but from forgetting basic habits. Lab coats, gloves, and goggles stop the small accidents turning into medical emergencies. In one facility, we kept emergency eyewash stations well-marked and trained on spill response. The rare times there was a leak, fast response and PPE avoided bigger problems.
Transporting any chemical in bulk brings its own problems. Sealed containers, clear hazard markings, and records of lot numbers keep mistakes from piling up. Pharmacopeia standards like BP, EP, and USP weren’t written on a whim—they came from years of lessons in mishandling and accidents. Adhering to these rules means less risk for everyone down the line, from drivers to technicians to patients relying on quality medications.
Waste disposal deserves just as much attention. I’ve delivered old or off-spec Methyl Myristate to certified handlers more than once. Flushing down the drain or mixing with incompatible chemicals causes lasting trouble—think environmental fines or regulatory shutdowns. Routine training and a bit of respect for protocols protect not only the workers, but the neighborhoods and water sources close by.
Day-to-day habits matter more than formal procedures alone. A team who treats each step with care avoids the setbacks that come from damaged ingredients or accidents. By focusing on clean labeling, proper storage, personal gear, and thoughtful waste handling, it’s possible to guard both people and product quality. In my own experience, this keeps workflows smoother, reputations solid, and everyone safer.
Methyl Myristate, used in pharmaceutical formulations, calls for a sharp eye on shelf life and packaging. In my years working with pharmaceutical-grade chemicals, nothing makes or breaks a batch faster than ignoring these basics. Stored in original, tightly sealed containers, away from heat, sparks, and sunlight, this ester keeps stable for around two years. Humidity can shorten its window, speeding up degradation. If opened and improperly resealed, even clean rooms can’t save you from risk of contamination—microbes love sneaking in.
With Methyl Myristate, expiration isn’t just a bureaucratic rule. Chemical breakdown impacts purity, and consequentially, the quality in pharma use. Even if the liquid still “looks” clear and colorless after two years, the chemistry might have shifted. Testing before use isn’t an afterthought. A batch released past shelf life without validation courts problems for the end product, especially for parenteral or topical applications.
Glass bottles and high-density polyethylene (HDPE) drum packaging pop up as the common choices, each for good reason. Glass shields against chemical reactions, and rarely leaches into the product. HDPE remains the favorite for large-scale because it offers resistance to impact during transit. Both types usually use tamper-evident seals, with a layer of foil or an inner plastic seal, making contamination obvious.
Methyl Myristate tends to get packed in batches of 25 kg or 50 kg drums in industrial setups. In pharmacy or R&D settings, you might see smaller amber glass bottles, often no more than 500 ml. Amber protects against light-induced degradation. I once watched a poorly stored, clear-bottled batch turn cloudy within months; that’s money wasted over a packaging shortcut.
Handling always matters. Technicians opening a drum without gloves, or transferring liquid with open lids, gamble with not just shelf life, but microbial and particulate purity. Closed transfer systems help, but they aren’t in every lab. Repackaging leads to another set of variables—original packaging gives the longest shelf life, but moving the content introduces the need to mark new expiration dates, based on both the supplier’s certificate and the environment in which the transfer happened.
I’ve learned to rely on Certificates of Analysis and periodic in-house QC. The documentation tells you purity, acid value, and moisture content right at the time of packing. storing the COA along with the chemical batch isn’t just a box-ticking exercise; it saves time if regulators ask questions. Regulatory agencies like the US FDA and EMA want evidence that storage and packaging keep the chemical within pharmacopeial requirements.
Solutions to stretch shelf life safely involve smart labeling and rotation. Marking every opened container with a date and user initials tracks usage and highlights exposures. Automated stock systems in large warehouses help, but the sharpest tool is usually a disciplined team that understands why these standards aren't just for show. Periodic retraining and spot audits don’t just prevent expired stock – they foster habits that directly improve patient safety.
Names | |
Preferred IUPAC name | Methyl tetradecanoate |
Other names |
Tetradecanoic acid methyl ester Methyl tetradecanoate Myristic acid methyl ester |
Pronunciation | /ˈmɛθɪl maɪˈrɪsteɪt/ |
Identifiers | |
CAS Number | 124-10-7 |
3D model (JSmol) | `CCCCCCCCCCCCCOC(=O)C` |
Beilstein Reference | 1722056 |
ChEBI | CHEBI:38697 |
ChEMBL | CHEMBL1405227 |
ChemSpider | 54452 |
DrugBank | DB14055 |
ECHA InfoCard | 13b46ae1-3ba3-4402-a6e6-fa9e431b2a83 |
EC Number | 203-689-4 |
Gmelin Reference | 8168 |
KEGG | C06482 |
MeSH | D015391 |
PubChem CID | 8211 |
RTECS number | WM4900000 |
UNII | F03X47VG6F |
UN number | UN3272 |
Properties | |
Chemical formula | C15H30O2 |
Molar mass | 270.45 g/mol |
Appearance | Clear, colorless liquid |
Odor | Faint, fatty odor |
Density | 0.86 g/cm³ |
Solubility in water | Insoluble in water |
log P | 5.9 |
Vapor pressure | < 0.01 mm Hg (20°C) |
Acidity (pKa) | 24.3 |
Basicity (pKb) | pKb ≈ 14 |
Refractive index (nD) | 1.430–1.434 |
Viscosity | 4.0 – 5.0 cSt (at 40°C) |
Dipole moment | 3.58 D |
Thermochemistry | |
Std molar entropy (S⦵298) | 505.8 J·mol⁻¹·K⁻¹ |
Std enthalpy of formation (ΔfH⦵298) | -889.1 kJ/mol |
Std enthalpy of combustion (ΔcH⦵298) | -8777.8 kJ/mol |
Hazards | |
Main hazards | May cause skin and eye irritation. |
GHS labelling | GHS07, GHS08 |
Pictograms | GHS07 |
Signal word | No signal word |
Hazard statements | No hazard statements |
Precautionary statements | Keep container tightly closed. Store in a cool, dry, and well-ventilated place. Avoid contact with eyes, skin, and clothing. Wash thoroughly after handling. Use personal protective equipment as required. |
Flash point | > 169 °C |
Autoignition temperature | > 400°C (752°F) |
Lethal dose or concentration | LD50 (oral, rat): >5000 mg/kg |
LD50 (median dose) | > 18,100 mg/kg (rat, oral) |
PEL (Permissible) | Not established |
REL (Recommended) | 10 mg/m³ |
Related compounds | |
Related compounds |
Ethyl Myristate Propyl Myristate Isopropyl Myristate Butyl Myristate Myristic Acid Methyl Palmitate Methyl Stearate Methyl Laurate |