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Methyl Hydroxybenzoate, often known as methylparaben, traces its pharmaceutical journey back to the early 20th century as researchers searched for preservatives to extend shelf life and maintain the safety of an expanding range of pharmaceuticals and personal care products. Chemists recognized their value after discovering how well these compounds prevent the growth of bacteria and fungi. The pharmaceutical world, always wary of product spoilage and contamination, found new confidence with methylparaben. Regulatory authorities encouraged standardized grades like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia). Each pharmacopoeia built its own set of standards, calling for high purity, precise identity testing, and limits on impurities. These standards created the framework that still defines quality across the pharmaceutical landscape. Pharmaceutical companies simply couldn’t ignore these requirements if they hoped to sell or export products to multiple regions.
Methyl Hydroxybenzoate belongs to the parabens group, ester derivatives of p-hydroxybenzoic acid. The pharma grade means strict control over each stage: from raw material sourcing, synthesis, purification to packaging. Most pharma products contain this ingredient at low concentrations, usually between 0.1% to 0.3%. The reason appears simple—methylparaben brings robust antimicrobial power, but is gentle enough to avoid irritation at low doses. I’ve seen manufacturers mix it with other parabens to cover a broader range of bacteria and mold, recognizing that no single preservative always delivers complete protection.
Pure Methyl Hydroxybenzoate feels like a fine, white crystalline powder with a faintly sweet aroma. It dissolves well in alcohol and ether, but only sparingly in water, often making solubilization the trickiest part for formulation scientists. The chemical structure, C8H8O3, offers a stable backbone, which translates to long shelf life in finished products. Melting point sits near 125°C. Its stability under normal storage conditions reassures pharmacists and quality assurance staff alike—unexpected spoilage becomes unlikely.
International pharmacopoeias demand a purity level exceeding 99%, and set strict thresholds for related substances, moisture content, and residue on ignition. Pharmacopeial tests require identity checks using infrared absorption, chromatography profiles, and reactivity tests. Labeling must clearly list its chemical name, grade, batch number, and expiry date. As regulatory scrutiny grows, manufacturers now include Certificates of Analysis with each shipment, ensuring traceability and compliance. Correct labeling, as I’ve learned, helps trace product origins in case of recalls or adverse events—turning a mountain of problems into something manageable.
Production usually involves esterification of p-hydroxybenzoic acid with methanol, catalyzed by concentrated sulfuric acid. The process demands close temperature control, precise reactant ratios, and cautious removal of excess methanol and acid residues. Extraction and recrystallization steps purify the compound for pharmaceutical standards. Engineers regularly check distillation columns, reactor pressures, and solvent quality—one slip damages purity, and the lot goes to waste. Safety protocols in synthesis rooms remain non-negotiable, since spills or vapors pose strong risks.
Methyl Hydroxybenzoate acts as a typical ester in many chemical reactions. Hydrolysis under acidic or alkaline conditions returns it to methanol and p-hydroxybenzoic acid. Formulators may blend it with ethylparaben or propylparaben, creating combined preservatives with improved antimicrobial activity across different microorganisms. Further modification, such as glycosylation or esterification with various alcohols, tailors it for specialty applications, including targeted release in drug delivery systems. These chemical tweaks draw the line between a basic preservative and a more versatile active ingredient.
Beyond “methylparaben,” authoritative catalogs list synonyms like methyl p-hydroxybenzoate, Nipagin M, and E218. Certain countries refer to it using food additive codes. Marketers occasionally rebrand it for consumer-facing products, yet for regulatory and scientific communication, the official nomenclature from BP, EP, or USP remains essential. Clarity in naming avoids confusion—no one enjoys discovering that two labels actually refer to the same substance after a lengthy review process.
Regulatory agencies such as the FDA, EMA, and national pharmacopeias require manufacturers to adopt current Good Manufacturing Practices (cGMP), covering sampling, production, storage, and distribution. Automation reduces contamination risk throughout packaging and warehouse monitoring. Workers must wear personal protective equipment when handling powders, and exhaust systems limit airborne dust. Documented training plans and regular auditing preserve not only worker safety but also the well-being of the end user. Risk assessments now guide every operational step, not as mere paperwork but as genuine safeguards everyone takes seriously.
Methyl Hydroxybenzoate shows up in a wide array of products, including tablets, creams, ointments, suspensions, and syrups. Its presence in topical medicines helps prevent mold or bacteria in products stored in humid environments. Many oral pharmaceuticals use it to maintain stability—even after years sitting in a warehouse. Hospitals and clinics trust its record, often preferring it over more obscure or experimental preservatives. It holds a steady place in personal care as well, primarily in lotions, deodorants, and cosmetics. Dermatologists rarely see reactions at recommended concentrations, but product labeling always flags the ingredient for those with sensitivities.
Researchers keep studying interactions with other excipients, the impact on drug release profiles, and the search for substitutes because of ongoing debates over long-term exposure. Advances in nanotechnology enable Methyl Hydroxybenzoate encapsulation, which may cut down direct skin contact or improve stability in sensitive formulations. Collaborative international research projects build better toxicity profiles, while industry forums push for preservatives with greener manufacturing footprints. These projects take time but will eventually influence regulations and industry practices. Drug safety assessors keep mining new data, expanding the evidence base required by regulatory reviewers.
Regulatory reviews and peer-reviewed studies agree that short exposure to Methyl Hydroxybenzoate at low concentrations brings little risk to most people. Animal studies show high oral doses can cause mild liver or kidney impacts, leading authorities to set maximum limits for concentrations in products. A few studies suggest weak hormone-like activity in animals, sparking ongoing debate among regulators and advocacy groups. Human patch testing studies report low rates of allergic reactions, so most health agencies have chosen not to restrict its use further, as long as suppliers stick to prescribed limits. I’ve noticed an increase in requests for in-silico modeling and sensitive detection of trace impurities, reflecting how much scrutiny this compound attracts.
Demand for safer, stable, well-documented preservatives remains strong in both pharma and personal care sectors, particularly with more countries setting up stricter pharmacopoeial requirements. The industry now expects broader allergen and impurity profiling, better environmental impact data, and support for clean-label trends. Ongoing advances in analytical chemistry will boost the ability to track ultra-trace residues or breakdown products and help shape future regulatory standards. Alternative preservatives compete for a place in new formulations, but Methyl Hydroxybenzoate’s established track record means it continues to serve as a benchmark. Upcoming research will probably improve safety data, drive innovation around green manufacturing, and refine its application in responsive and targeted drug delivery. As regulations and consumer expectations shift, industry leaders must balance performance, safety, and transparency; Methyl Hydroxybenzoate offers lessons in how old solutions adapt to new challenges.
Medicines often come in forms that invite trouble if left unprotected. Methyl hydroxybenzoate, better known as methyl paraben, steps up as a reliable shield against contamination. Without it, any syrup on a pharmacy shelf or cream in a bathroom cupboard becomes a target for bacteria and mold. Fungi love sugars and moisture, two things often present in medicines. I’ve seen bottles of syrup go cloudy and creams start to smell odd because someone tried to skip the preservative. Just a bit of methyl hydroxybenzoate, used within proper limits, prevents this sort of microbial growth.
I remember talking to a pharmacist who said, “If you’ve ever wondered why medicine stays safe long after opening, preservatives like this one do the heavy lifting.” This isn’t about scaring people with horror stories; it’s plain reality. Medicines, especially liquid forms, degrade faster without a preservative holding the fort.
This compound comes with the assurance of BP, EP, and USP grades. These aren’t meaningless sets of initials; they stand for British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. When a substance carries these badges, patients and manufacturers both benefit. It means the preservative matches the strict standards necessary for drug production. Any time I pick up a package and see those letters, I know quality and consistency follow.
Doctors and pharmacists trust products with methyl hydroxybenzoate because these standards rule out impurities and make sure every dose looks and works the same. Consistency has real world effects. One batch of medicine without enough preservative can trigger recalls. There’s always a cost to cutting corners.
Concerns about parabens, the family of chemicals that includes methyl hydroxybenzoate, get a lot of press. People worry about allergies or broader health effects. The vast majority of studies and regulatory reviews conclude that small, regulated amounts don’t present a risk. That’s not a blank check to use too much. Careful dosing prevents issues for those with sensitivities and keeps products safe for the general population.
Regulators limit how much methyl hydroxybenzoate can go in each product—generally up to 0.2% or 0.3%—which keeps side effects rare. During my time in pharmacy, I occasionally spoke to patients who thought all preservatives were dangerous. After pointing out that unpreserved cough medicine could lead to much greater health risks, most agreed the trade-off made sense.
Some companies push to avoid any synthetic additives and look for natural options. These ideas deserve support, but so far, few natural alternatives match the broad protection of methyl hydroxybenzoate. Plant extracts and alcohol work in some cases, but usually can’t guarantee the longer shelf life or stability pharmaceutical companies want.
Until something better comes along, using trusted preservatives under a careful eye gives both manufacturers and users peace of mind. The best path forward keeps science and patient safety in balance, never assuming that skipping a step won’t come back to bite.
Methyl hydroxybenzoate, often labeled as methyl paraben, finds its way into a surprising range of pharmaceutical products. You’ll see it in cough syrups, topical creams, even eye drops. Its key role — stopping bacteria and fungi from turning a safe medicine into a recall headline. I’ve watched regulators tighten standards as consumers grow more aware of what slips into their medicines. Meeting those standards isn’t about red tape; it means safety for everyone using these products at home.
Walk into any pharmaceutical company and ask for pharma grade, and you’ll quickly see the bar is set high. Strict specifications define what goes in and — almost more importantly — what stays out. The content of methyl hydroxybenzoate has to hit a narrow range, usually between 99.0% and 100.5%. Doctors and pharmacists trust manufacturers to stick within this window. Impurities — formaldehyde, heavy metals, other parabens — must stay at vey low levels, for example, heavy metals below 10 ppm and sulfated ash below 0.1%. Any detectable trace of a banned contaminant gets flagged.
It’s common for manufacturers to follow official compendia like the USP (United States Pharmacopeia) or Ph. Eur. (European Pharmacopoeia) standards. They detail melting point (125–128°C), clarity in water and alcohol, specific optical rotation, and the absence of unwanted substances. Each of these parameters acts almost like a fingerprint, ensuring the batch will not surprise doctors or patients down the line.
Once, I watched a quality control analyst describe how one impure batch delayed a shipment. It wasn’t about buyer complaints—it was about restoring trust. Medicine safety only works when every batch of pharmaceutical ingredient performs exactly as the label promises. Poorly purified excipients can spark allergic reactions, cause stinging in eye drops, or interact with active ingredients to create toxic byproducts.
The real concern comes when standards slip at the source. Counterfeit or poorly controlled manufacturing threatens a supply chain, which then jeopardizes the person depending on their medicine. Even low-level contaminants may accumulate in the body over time and cause problems that aren’t obvious at first glance.
According to the World Health Organization, pharmaceutical excipients need control at every step — from raw materials to finished product — as part of good manufacturing practice. Recalls linked to subpar excipient quality continue to surface around the globe. One study in the Journal of Pharmaceutical Sciences noted that batches failing on purity were more likely to contribute to side effects and reduce product shelf life. So, it’s not just the law demanding these tests — it’s lived experience and real-world consequences.
Having worked alongside chemists in pharma labs, I’ve seen solid solutions. Regular third-party audits drive accountability. Up-to-date analytical instruments make it harder for impurities to sneak by undetected. Suppliers and buyers need open, honest communication — sharing certificates of analysis, transparent documentation, even on-site visits. Building traceability in the supply chain catches a lot of issues before they land at the factory door.
Above all, education at every level — from manufacturer to healthcare worker — creates a shared responsibility. Setting firm specifications for methyl hydroxybenzoate isn’t just about ticking boxes. It means respecting the trust patients place in every medication they take.
Methyl hydroxybenzoate shows up on the labels of many creams, shampoos, syrups, eye drops, and even toothpaste. Some know it as methylparaben. As a preservative, it fights bacterial and fungal growth. The goal is simple: keep products from spoiling and keep them safe to use over time. Nobody wants mold in their face cream or bacteria thriving in their cough syrup.
People debate the safety of preservatives. Many have become wary about any chemical name that sounds complicated. Studies from organizations like the US Food and Drug Administration and the European Medicines Agency show that methyl hydroxybenzoate, at the concentrations used in medicine and skincare, stays well tolerated for most people. Absorption through the skin happens slowly, and the compound quickly gets broken down by the body. Most is flushed out in urine within a day.
I’ve seen online sources sound alarms about potential hormone disruption. Reports from clinical trials show only high doses, much higher than any practical use, produced any hormone-related effects in animals. Those amounts do not match what's in a typical jar of moisturizer or bottle of tablets.
The strongest criticism often comes from animal studies in labs, not daily life experience. It’s useful to ask, do those experiments reflect what’s on your bathroom shelf? Health authorities have kept reevaluating new data for decades. Each time, methyl hydroxybenzoate remains on the list of approved ingredients. If an ingredient was causing large-scale harm, it would not stay approved.
It would be misleading to say there’s zero risk. Sensitivity matters. Some people—especially with allergies or eczema—might notice skin irritation or a rash. I’ve seen patients with very reactive skin prefer products labeled “paraben free.” Doctors recommend patch testing for anyone with a history of allergic reactions to skincare or topical medicines. Parents sometimes worry about it in products for children. Regulators set lower allowable concentrations in pediatric medicines for this reason. Asking your pediatrician gives peace of mind.
Many people seek out “natural” products, expecting fewer synthetic preservatives means fewer risks. Enter coconut oil, grapefruit seed extract, or rosemary extracts. While plant-based options sound appealing, they often fail to deliver the same protection against bacteria and mold. I’ve seen creams spoil within weeks when stored at room temperature with no synthetic preservative at all. The risk of infection from spoiled products outweighs theoretical risks from approved preservatives for most people.
Demand for transparency in ingredient lists has risen. Companies respond by sharing clear information about what goes into their formulas. I respect consumers who make choices based on personal comfort and values. In medical products, quality testing and pharmacist-led advice help find suitable options if allergies happen. For the most sensitive patients, compounded medicines without methyl hydroxybenzoate remain available with a prescription.
Methyl hydroxybenzoate stays in use not out of habit, but because after years of research and monitoring, it continues to make medicines and cosmetics safer by preventing spoilage. No ingredient is perfect for everyone, though. Personal responsibility—reading labels, listening to your body, and consulting with healthcare professionals—helps find the best fit for each individual’s health and peace of mind.
Methyl hydroxybenzoate hits a lot of pharmaceutical ingredient lists for its preservative punch. From my years around pharma supply chains, folks expect a simple answer to shelf life. Data says three to five years if it’s untouched in original, sealed containers. Manufacturers stamp those dates based on real-time and accelerated stability studies, not a guess. What brings that number down isn’t just the ticking clock—it’s conditions where the chemical sits.
Placing this compound in a dry spot matters. Moisture is the enemy of most benzoates. Deliquescence or clumping shows a humidity problem; these signs get ignored until someone opens a drum that looks like a bag of marshmallows. I learned early that most temperature issues come from suppliers storing drums near loading docks or sunny windows, not just someone cranking up the thermostat. Higher temperature speeds up decomposition and, worse, invites product recalls if breakdown products show up in finished medicine. A tight lid and a cool, shaded corner add real months to its safe use.
Direct sunlight does a number on pharmaceuticals. Light camps out at the top of the list of triggers for degradation. I’ve seen handlers grab from a sunlit stack without thinking twice—until the batch analysis comes back off-spec. UV light changes chemicals faster than most realize, and pharmaceutical methyl hydroxybenzoate breaks into different forms that can’t guarantee safe, effective medicine.
The real test of shelf life starts with the first opening. A scoop, a spatula, or even a quick whiff exposes the material to air. Oxygen and airborne particles sneak into the container, and the clock spins faster. I’ve watched teams use sticky tape as a fix; those attempts rarely keep out enough moisture or air. Labs and manufacturing floors that stick with well-fitting, screw-top lids keep their product fresher longer.
Trustworthy suppliers issue certificates of analysis, batch-specific expiration dates, and usually offer advice if storage conditions slip. A lot of issues show up where site staff either never saw the storage guideline or tossed it with the packing slip. Good practice means checking those certificates, not just filing them away. If methyl hydroxybenzoate comes out clumpy, yellowed, or smells off, it’s time for replacement. My experience says addressing those issues on the spot avoids failures at the drug release stage later.
Letting storage drift often means risking patient safety and regulatory trouble. Regulatory agencies check storage logs, and gaps bring on extra scrutiny. Routine checks of the storage area and a habit of rotating stock by arrival date keep risks down. It helps to nominate one team member for monthly audits—missing an expired or poorly stored drum costs more in recalls or destroyed product runs than paying attention from the start.
Simplicity protects investment and patients alike. A dry, cool, dark spot, a record of opening dates, and regular checks matter more than fancy temperature loggers when budgets get tight. Applying facts—three years in the right conditions, less if opened—beats any guesswork and builds trust from the warehouse to the patient’s bedside.
Companies buying pharmaceutical ingredients like Methyl Hydroxybenzoate follow strict protocols long before any order hits the warehouse. A Certificate of Analysis (COA) and a Material Safety Data Sheet (MSDS) aren’t optional extras—they’re integral for both compliance and safety. In my work with pharmaceutical sourcing teams, I've watched deals stall just because suppliers couldn’t produce valid documents. If a batch arrives without a proper COA showing it meets BP, EP, or USP standards, there’s no way for quality teams to confirm its purity, potency, or safety profile.
A COA functions as a snapshot. It stakes a claim about what’s in the drum, based on actual testing performed. I’ve seen COAs stop contaminated product from ever entering a mixing tank. The document usually lists physical characteristics, related substances, assay values, heavy metal content, residual solvents, and microbiological purity. For Methyl Hydroxybenzoate, these parameters are not just numbers—they flag if the raw material can legally and safely end up in a medicine.
An MSDS gives a different kind of assurance. It tells handlers how to store, transport, and use the chemical without getting hurt. I remember visiting a contract manufacturer where the lack of a readable MSDS led to workers mishandling a supposedly benign ingredient. The accident, though minor, underscored how a missing page can risk lives and disrupt supply chains. MSDS documents cover sections on hazards identification, first-aid measures, stability, and proper disposal. They anchor a facility’s health and safety training.
Auditors from regulators want traceable paperwork. GMP guidelines demand complete documentation for every active and inactive ingredient. Missing or outdated COAs/MSDSs can trigger recalls or suspensions. Once, a missing batch-specific COA for Methyl Hydroxybenzoate forced a production line stoppage costing tens of thousands in lost output and diligent hours spent gathering fresh paperwork. It’s not just about ticking boxes—it’s about building real confidence in the supply chain.
Many producers now run in-house or accredited third-party labs for each lot, and supply digital copies of COAs and MSDSs directly linked to batch numbers. Still, buyers ought to check if the supplied COA maps to the product received. I’ve advised clients to confirm the lab’s accreditation and the analyst's signature authenticity—issues like forged or generic certificates have crept into markets before. Collaborative platforms or blockchain tools help by making documents tamper-evident and instantly shareable, but plenty of procurement remains face-to-face, and trust is built on experience and scrutiny.
For companies sourcing worldwide, language barriers and regulatory mismatches crop up. Not all COAs are created equal; reviewing parameters to confirm alignment with BP, EP, or USP standards takes technical know-how. When in doubt, I’ve seen buyers fall back on independent lab testing, choosing cost over risk. This isn’t just about passing audits—it’s practical risk management that protects patients and a company’s reputation.
COA and MSDS documentation for Methyl Hydroxybenzoate isn’t just bureaucracy—it sets the framework for a safe, effective medicine supply. Teams who treat these documents as living, breathing tools, not dead weight, make better decisions every step of the way. Their diligence supports safe workplaces, regulatory compliance, and better public health outcomes.
| Names | |
| Preferred IUPAC name | methyl 4-hydroxybenzoate |
| Other names |
Methylparaben Methyl p-hydroxybenzoate Methyl 4-hydroxybenzoate |
| Pronunciation | /ˈmɛθ.ɪl haɪˌdrɒk.si.bɛnˈzəʊ.eɪt biː piː iː piː juː ɛs piː ˈfɑː.mə ɡreɪd/ |
| Identifiers | |
| CAS Number | 99-76-3 |
| 3D model (JSmol) | `CCCC(=O)Oc1ccc(O)cc1` |
| Beilstein Reference | Beilstein Reference 969924 |
| ChEBI | CHEBI:30762 |
| ChEMBL | CHEMBL1407 |
| ChemSpider | 5339 |
| DrugBank | DB00719 |
| ECHA InfoCard | ECHA InfoCard: 03-2119729501-54-0000 |
| EC Number | 202-785-7 |
| Gmelin Reference | 7871 |
| KEGG | C05955 |
| MeSH | D008950 |
| PubChem CID | 7457 |
| RTECS number | DH2450000 |
| UNII | YLW0YLN434 |
| UN number | UN2811 |
| CompTox Dashboard (EPA) | Methyl Hydroxybenzoate BP EP USP Pharma Grade CompTox Dashboard (EPA) string: **DTXSID1041545** |
| Properties | |
| Chemical formula | C8H8O3 |
| Molar mass | 152.15 g/mol |
| Appearance | White or almost white crystalline powder |
| Odor | Odorless |
| Density | 1.36 g/cm³ |
| Solubility in water | Slightly soluble in water |
| log P | 0.96 |
| Vapor pressure | <0.1 mmHg (20°C) |
| Acidity (pKa) | 8.2 |
| Basicity (pKb) | 8.4 |
| Refractive index (nD) | 1.538 |
| Viscosity | Viscosity: 1.185 mPa·s (at 75 °C) |
| Dipole moment | 2.64 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 152.5 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -505.6 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | –5056 kJ/mol |
| Pharmacology | |
| ATC code | S01XA02 |
| Hazards | |
| Main hazards | May cause eye, skin, and respiratory irritation. |
| GHS labelling | GHS02, GHS07 |
| Pictograms | GHS07 |
| Signal word | No signal word |
| Hazard statements | No hazard statements. |
| Precautionary statements | P264, P270, P273, P280, P301+P312, P305+P351+P338, P337+P313, P330, P501 |
| NFPA 704 (fire diamond) | Health: 1, Flammability: 1, Instability: 0, Special: - |
| Flash point | > 200°C |
| Autoignition temperature | 580°C |
| Lethal dose or concentration | LD50 (oral, rat): > 2,000 mg/kg |
| LD50 (median dose) | LD50 (median dose): 2100 mg/kg (oral, rat) |
| NIOSH | Not listed |
| PEL (Permissible) | 125 mg/m³ |
| REL (Recommended) | 0-10 mg/kg bw |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Benzoic Acid Ethyl Paraben Propyl Paraben Butyl Paraben Sodium Methylparaben Methylparaben Sodium Salt Methylparaben Potassium Salt |
Chengguan District, Lanzhou, Gansu, China
