Contact Us
Chengguan District, Lanzhou, Gansu, China
© 2025 Jeifer Pharmaceutical, All Right
Reserved.
Iron oxide pigments stretch far beyond laboratory glassware and pharma clean rooms. Traces of iron oxide black, known as magnetite, turn up in prehistoric cave painting sites and objects from ancient civilizations. The journey from raw minerals to critical pharmaceutical ingredient covers centuries and continents. Early societies found these minerals not only by their magnetic properties but also by their deep, lasting hues. Industrial production methods only started ramping up in the 19th century. With regulatory demands in Europe and the United States tightening by the end of the 20th century, processes shifted sharply toward higher purity and quality for applications in medicine, food, and cosmetics. These requirements spurred a new wave of scientific attention to iron oxide black, approaching it as a compound to be standardized, purified, and tested - not just mined and ground.
Iron oxide black, typically featuring the formula Fe3O4, is produced in forms meeting British Pharmacopeia (BP), European Pharmacopeia (EP), and United States Pharmacopeia (USP) standards. What sets pharma grade apart is not a dramatic change in the elemental composition but a guarantee of fewer impurities, minimal heavy metal residues, no microbial contamination, and a consistent, easily characterized particle profile. The industry shifts sharply from the rough and ready pigments of construction or paints to a material scrutinized under the microscope and by mass spectrometry. This shift underpins trust between manufacturers, regulators, and ultimately patients relying on medication with iron oxide black as a colorant or excipient.
Fe3O4 stacks up as a dense, jet-black powder with a close-to-neutral pH in aqueous suspension. Its magnetic behavior makes it easy to distinguish from other black pigments. Pharma grade powder runs fine and free-flowing, with strict upper size limits in place to reduce clumping and ensure even suspension in liquid or solid mixtures. Water insolubility proves vital for safe ingestion in tablets and coatings, avoiding chemical reactions that could leach iron ions in unpredictable quantities. Besides this, it resists breakdown under light and heat, a simple yet crucial property fostering long shelf-life for color-coated drugs.
Every container leaving a manufacturer has to list more than batch numbers and storage advice. Clear, non-negotiable technical specifications show the total iron content, assay range, loss on drying, magnetic properties, and strict upper limits for toxic elements like lead, arsenic, and mercury. These details go well beyond what a painter or engineer cares to see, reflecting heavy scrutiny by regulators and hospital purchasers alike. With label transparency, supply chains have fewer questions and traceability stays intact during recalls or quality audits—a lesson learned the hard way by many in pharma.
Industrial-scale production rarely happens in small, stovetop batches. Synthesis usually kicks off with controlled oxidation of ferrous salts or direct precipitation using iron(II) and iron(III) salts under basic conditions. Technicians manage pH, temperature, and reaction times to get the right particle size and phase purity, dodging excess limonite or goethite co-precipitation. Manufacturing lines run closed, automated, and with continual quality checks, keeping the process efficient but also safe from cross-contamination. The result: pharmaceutical containers filled with consistent, high-purity Fe3O4 ready to be milled, washed, sterilized, and shipped.
Iron oxide black stands strong against air and water, which gives it a leg up in terms of product shelf life. It can take on functional groups at the surface if needed, such as coatings that make it more dispersible in organic solvents or specific drug matrices. Chemists have explored doping Fe3O4 with manganese or cobalt for imaging uses or altering particle size for better drug loading in targeted therapies. In most tablet and syrup applications, such modifications aren’t pursued, but the possibility underpins active research into advanced delivery systems for pharmaceuticals of the future.
Naming conventions in this field stay confusing for newcomers. Magnetite, black iron oxide, ferrosoferric oxide, and E172 all point to the same core substance. In regulatory labeling, E172 appears on food and pharma ingredient lists, making it much more visible to consumers than obscure mineralogical terms. Some names crop up (such as CI Pigment Black 11 or Pigment Black 11) in paint and ink industries but for pharma, labelling sticks to precisely defined codes in pharmacopeias for consistency across countries and sectors.
Handling protocols reflect the strict demands of the pharmaceutical industry. Personal protective equipment, controlled environments, and regular air and surface monitoring underpin daily operations. Routine analytical testing ensures each batch meets published standards for microbial content, heavy metals, and unwanted chemical residues. Workers carry out gravimetric and colorimetric tests on site, complemented by third-party validation for regulatory submissions. No shortcuts—major recalls in the recent past show that even seemingly inert pigments like Fe3O4 demand as much rigor and compliance as active pharmaceutical ingredients.
Iron oxide black colors tablets, capsules, and some liquid formulations. It serves more than an aesthetic function: consistent color assures users of product authenticity, especially in over the counter pain relief or vitamin supplements. In a competitive market, distinct product appearance can reduce confusion and medication errors—a reality known to everyone who’s ever sorted handfuls of pills each week. Further afield, Fe3O4 finds roles in MRI imaging, nanomedicine, and drug delivery systems, but in the pharmacy aisle, its reputation stands as a reliable coloring agent with a decades-long safety record.
Most pharmaceutical advances in Fe3O4 lean on engineering the particle size and surface characteristics for new therapeutic uses. Nanoparticle research keeps ramping up, with the magnetism of Fe3O4 used for guided drug delivery or hyperthermia treatments. Labs measure how chemical coatings and size tuning affect bioavailability, toxicity, and efficiency in real-world settings. Academic and industry teams keep crossing silos to push the limits of established materials, driven both by regulatory changes and a creative hunt for better patient outcomes.
Every substance crossing into the pharmaceutical supply faces intense toxicity screening. Decades of use support a strong case for Fe3O4 as a low-risk colorant at regulated doses. Published studies cover acute, chronic, and reproductive toxicity, plus impacts on vital organs. Researchers track plasma iron levels and look for evidence of iron overload or hidden metabolic issues. Reviewing these outcomes keeps both manufacturers and healthcare providers alert to emerging risks. Regulatory agencies continue to re-examine their monographs, balancing widespread historical use with new data and techniques in toxicology.
Growing demand for safe, traceable excipients in pharmaceuticals puts more spotlight on sourcing and purity standards. As personalized medicine expands and consumers take a greater interest in inactive ingredients, suppliers face challenges to prove ongoing quality and origin. Research trends hint at even closer integration between functionalized Fe3O4 and active drug components, possibly in targeted cancer therapies or site-specific imaging agents. Green chemistry methods in Fe3O4 manufacture also draw attention, aiming for lower energy, less waste, and better stewardship of mineral resources. Adaptation and transparency will likely decide which suppliers stand out in a world where even the “inert” ingredients get their time under the microscope.
People often spot Iron Oxide Black as a listed ingredient in tablets and capsules, but the reasons run deeper than just adding color. Its pharmaceutical grade means it meets strict standards for safety, purity, and trace elements. Manufacturers use it not just to make pills look better, but to help patients tell different medications apart. A diabetic checking several daily pills relies on color to stay safe. The FDA and European Pharmacopeia demand this level of attention because even everyday ingredients like this play a vital part in patient health.
Coloring agents like Iron Oxide Black prevent medication mix-ups, and that saves lives. Hospitals see fewer errors in prescription handling when pills have distinct colors. Anyone managing their medications knows the relief that comes from confident recognition. Iron Oxide Black also withstands light and moisture, so the medicine survives dusty medicine cabinets or long shelf lives without fading or degrading. This consistency means people can trust the bottle they open is as effective as the day it left the factory.
Iron Oxide Black doesn’t just show up in pharmacies. Dentists and dental labs use it in custom mouthguards and dental prosthetics to achieve natural shades and durable results. In dietary supplements and some vitamins, the pigment gives tablets a distinct tone, setting one supplement apart from another while assuring regular consumers about authenticity and source.
The pigment’s stability means it withstands harsh conditions, which matters to supplement manufacturers. Vitamins and herbal pills sometimes see months in warehouses or heat during shipping. Iron Oxide Black holds its ground, giving businesses and customers confidence that what they see is what they get. Adulteration or fade-outs in color could pose real risks, and for brands who work to build trust in a crowded supplement aisle, the quality of something as “small” as the color goes a long way.
Diagnostic labs use Iron Oxide Black for some contrast agents in imaging or sample marking. Its safety record and stable composition let technologists work without concern over toxic reactions. In topical medicines and even in regulated cosmetics, it offers deep color without skin irritation. I have heard from pharmacists and dermatologists that patients with sensitive skin often fare better with products colored by iron oxides compared to synthetic dyes.
The application relies on trusted supply chains. Counterfeit or impure colorants carry health risks. Regulators specifically monitor pharma grade Iron Oxide Black for heavy metals and contaminant levels, making it safer for all end users. From the perspective of quality assurance, focusing on approved grades drives up costs a bit, but the trade-off is fewer recalls, less wasted product, and much higher consumer safety.
Sourcing Iron Oxide Black from ethical and audited suppliers remains the key challenge. Environmental concerns, especially with the extraction and processing of iron ore, need ongoing attention. Pharmaceutical companies now partner with suppliers using greener mining and purification techniques. Some research teams even explore synthetic routes that use less energy. For supply chains, digital traceability helps root out sources that don’t follow safety or environmental rules.
The only way forward that matches safety with responsibility involves full transparency about sourcing, pushing for third-party audits, and supporting innovation in cleaner processing. The peace of mind it brings to patients, pharmacists, and families matters far more than the low cost of a shortcut or a compromise in quality.
Iron oxide black often goes into pills, ointments, powders, and makeup as a coloring agent. Its deep color covers up bland or uneven base materials in creams, tablets, and mascaras. When working in a lab or manufacturing setting, picking colors isn’t just an aesthetic choice. Everything picked for a product must satisfy strict regulations and must not cause harm. Iron oxide black with the BP, EP, and USP tags has passed through certification hoops under the British, European, and United States Pharmacopeias. These standards define the limits for impurities, particle size, and purity.
Years of reviews by safety panels inform how iron oxide black appears on many global regulatory lists. The U.S. Food and Drug Administration lists iron oxides as permitted for cosmetics and drugs, provided they’re processed to meet heavy metal and contamination limits. Safety isn’t just assumed because iron is common in the environment; regulators know dust or trace metals can bring trouble. For a pigment to carry a pharma grade label, it undergoes heavy cleaning, grinding, and analysis to strip out contaminants and ensure consistent quality.
The European Medicines Agency and similar bodies in other countries also maintain tight rules for pharmaceutical ingredients. They check for bacteria, heavy metals like arsenic or mercury, and other toxins. Manufacturers handle documentation like batch sheets and certificates of analysis for every batch. In practice, reputable companies go far beyond minimum legal requirements, since a recall damages trust for years.
Not all iron oxides play by the same rules. Some grades turn up in road paint or ceramics and would never pass pharma or cosmetic review. Black iron oxide with BP EP USP certification comes with a laboratory guarantee: lead, arsenic, and mercury stay at safe levels, often below 10 parts per million or less. In my work with manufacturing teams, most concerns focus less on the iron compound itself and more on the unwelcome extras like nickel or chromium that sneak into lesser grades.
Cosmetic products that use iron oxide black avoid allergy complaints and reactions in most people. Iron oxide is not absorbed through the skin in measurable amounts, and it won’t clog pores or cause systemic issues at ingredient levels allowed for these products. Rarely, people with sensitive skin mention irritation, though that often links to other formulation ingredients.
Oral administration raises slightly different questions. Pharmaceutical tablets deliver small, clearly measured doses, and safety evaluations stretch across years of clinical studies. Iron oxide black does not build up in the body. What is ingested either passes through or breaks down without drama.
Safe use comes down to sourcing and testing. Buyers can make mistakes by chasing price or skipping the paperwork. I have seen situations where small companies ordered “industrial” pigment, assuming all iron oxide is the same, with rusty results. Choosing certified ingredients, checking supplier reputation, and demanding lab certificates every time set a culture of accountability. Batch recalls are rare for this pigment, yet they stick out because traceability matters.
Iron oxide black BP EP USP pharma grade earns trust from regulators, chemists, and consumers through transparent testing and rules-based manufacturing. Winning trust means more than passing one lab test—it comes from steady vigilance and a willingness to ask tough questions about origins and quality controls.
Iron oxide black turns up in the coatings and cores of many tablets, capsules, and oral suspensions. Pharmaceutical companies can’t afford surprises in this arena, as particle size links directly to product safety, aesthetics, and even how drugs move through the body. In my own work in pharmaceutical production, I've seen how a stray clump of colorant can set off a cascade of operational headaches—batch failures, discolored pills, and expensive recalls. Manufacturers use tight controls to keep things smooth. Most pharma grade iron oxide black falls between one and ten microns in particle size. Particles much larger than that can look grainy and throw off tablet uniformity. Too fine, and they tend to fly everywhere and cause issues with dust control, clogging filters, and dispersing poorly during blending.
Tests built into standard operating procedures, like laser diffraction and sieve analysis, regularly monitor particle size. These checks ensure nothing unpredictable ends up in the mix. In my experience working alongside quality teams, the days with no alarms about colorant contamination are usually the days when everyone can breathe a little easier. Keeping the particle size in that narrow sweet spot reduces risks.
Purity isn’t a small matter for pharma grade iron oxides. Regulatory expectations from authorities like the FDA or EMA keep a close watch on trace metals and impurities. Iron oxide black for pharmaceuticals usually boasts a purity of 98% or above—sometimes nudging right up to 99%. That helps keep worries about contaminants like lead, arsenic, and mercury at bay, since these elements can wreak havoc at even low concentrations.
Looking at certificates of analysis from leading global suppliers, common spec sheets show lead levels below 10 ppm (parts per million), mercury under 3 ppm, and arsenic under 3 ppm. Anything beyond those tight levels would never get through a quality review in a plant I’ve worked in. Systems built on Good Manufacturing Practices (GMP) and Validation clamp down hard on anything suspect. I’ve seen batches paused for investigation because a trace amount of contaminant threatened the overall quality, and how quickly teams are mobilized to identify the source.
Consistent color might seem like a small thing, but anyone who’s ever taken a daily medicine understands how much trust rides on that pill’s appearance. Even slight changes in color from batch to batch can set off phone calls from pharmacists and worries among patients. Reliable particle size and purity directly support that sense of safety.
In product development meetings, quality assurance leaders often mention patient safety as the line that doesn’t ever move. That mentality keeps iron oxide suppliers on their toes and explains why pharma grade is a different beast than grades used in paints or ceramics. Pharma grade batches run under stricter testing and documentation, and skip shortcuts in sourcing or processing.
With safety on the line, some industry leaders now look to green chemistry and improved purification technology. Methods like high-efficiency filtration, precision milling, and real-time in-line testing equipment mean fewer bad surprises and more consistent product. Engaged purchasing teams work with suppliers who show robust traceability, reducing the chances of contamination from the supply chain.
Having seen breakthroughs in other excipients and coatings, I expect more investment in particle engineering and impurity elimination for iron oxides in the future. That pays off not only in regulatory harmony but in fewer production disruptions and fewer stories of returned medications. Trust, after all, grows batch by batch, built on the invisible science that starts with the tiniest black particles.
Anyone dealing with pharmaceuticals will hear a lot about BP, EP, and USP standards. These are not simply boxes to tick—they are entire frameworks that decide if a product can actually serve patients safely. BP stands for British Pharmacopoeia, EP means European Pharmacopoeia, and USP represents United States Pharmacopeia. Every serious pharmaceutical supplier, whether raw ingredients or finished pills, talks about these benchmarks constantly because they are the gold standard for quality, safety, and consistency.
Too many people think these standards only pad paperwork. As someone who has watched medicines move from lab benches to pharmacies, I know these rules cut real-world risks. For example, the BP, EP, and USP each spell out exact tests and limits for things like purity, moisture, heavy metal traces, and how the body will process a compound. Regular testing isn’t optional. Customers and, more importantly, patients rely on rock-solid consistency. A batch that slides through without meeting standards doesn’t just risk financial penalties—it puts lives in danger.
Simple aspirin, for instance, isn’t just about acetylsalicylic acid. Impurities, particle size, even tiny residue from cleaning agents can trigger legal problems and health hazards. That’s why these pharmacopeias outline the tiniest details. Regulators and manufacturers know that cutting corners has serious consequences. No parent wants to wonder if their child’s medicine might be subpar. No doctor wants doubts in the back of their mind about the product in their hand.
Sourcing from a supplier who skips standards only invites recalls, damaged trust, and—for small manufacturers especially—financial disaster. My own experience in procurement taught me that price rarely makes up for quality gaps. A bad batch might pass basic checks at first, but next month the same batch might start causing side effects because some “minor” impurity crept in. Regulators take a dim view of such shortcuts. The cost of product recalls, destroyed stock, and legal action can wipe out any savings from cheaper, low-quality sources.
Trust but verify sums up my approach. Suppliers claiming BP, EP, or USP compliance should offer full traceability of their batches. COAs (Certificates of Analysis) have to match up with actual published pharmacopeial monographs. If someone hesitates or tries to explain away vague documentation, that’s a red flag. I’ve watched too many audits trip up on missing certificates, uncalibrated equipment, or just vague “yes, we comply” statements.
Often, a trusted supplier can provide not just the test results but precise reference standards used in those tests. This level of detail is typical among reliable manufacturers in Europe, the US, and increasingly, other global markets. Regulators are tightening up, and companies not keeping pace get caught off guard.
Companies taking compliance seriously invest in ongoing staff training, regular equipment calibration, and constant updates as pharmacopeial standards evolve. Audits might be stressful, but they build a stronger reputation and customer loyalty. Investing in quality systems and documentation pays off every time. Patients rarely know the name of an API manufacturer, but their lives depend on someone doing this work well. Margin for error—whether in production, storage, or transport—remains slim.
Every player in the supply chain, from ingredient makers to packaging firms, carries the weight of compliance. Following BP, EP, and USP standards isn’t just about avoiding fines or crossing off regulatory checklists. It’s about guaranteeing that every dose, every batch, every shipment meets promises made to those who depend on these products most.
Iron Oxide Black in its BP, EP, and USP Pharma grades carries a pharmaceutical pedigree. This isn’t just cosmetic pigment—the stakes run higher, touching human health. So, the little, common-sense things about storage and handling go a long way. Folks in the trade know environmental controls matter, but sometimes cutting corners gets tempting, especially in older labs or cramped storerooms. This is where headaches crop up.
Iron Oxide Black pulls in water if given half a chance. Moisture leads to caking, makes blending tricky, and in worst-case scenarios, triggers slow chemical changes. Working in pharmacy years ago, I saw more than one tightly sealed container betray that telltale crust on opening, thanks to a humid storeroom. Storing the powder in a cool, dry area with reliable air conditioning makes all the difference. Using desiccants inside bins creates a second layer of defense. Sealing the powder right after every use keeps the product true to spec.
Temperature swings force containers to “breathe,” pushing air—and any moisture—inside. Sometimes this even alters particle consistency. Keeping the storage steady, between 15–25°C, helps the powder stay in its intended form. None of this draws attention day-to-day—until someone uncovers clumps or gets batch-to-batch variability in mixing. Better to check the thermometer now than patch up headaches later.
Any pharma-grade powder attracts contaminants if left exposed. Iron oxide powders tend to pick up lint, dust, or even particles from previous jobs. Gloves and masks seem like a chore, but they stop stray hands or breath from ruining an entire stock. Dedicated, labeled tools for scooping, transferring, and weighing powder make sense. In my lab days, we had red ladles for red iron oxide, black for black, just to avoid mix-ups. It stuck, because when someone slipped, QA caught it straight away. Mixing batches should only ever happen on clean, wiped-down surfaces.
Storing only what you can use within twelve to eighteen months dodges most problems. Old stock gets forgotten behind fresh deliveries, and surprises crop up during stock-taking. Adopting a simple “first in, first out” system ensures no batch gathers dust or loses quality before use. Doing regular quality checks stops questionable material from sneaking into production. A batch lost to mishandling or contamination costs more in downtime and stress than proper care or replacement.
Iron Oxide Black’s dust isn’t deadly, but frequent inhalation irritates throats and causes unnecessary coughing fits. Janitors and newcomers tend to notice this more than old hands. Simple solutions—properly fitted masks, ventilation near mixing stations, thorough training—beat any excuse. Spills don’t happen daily, but keeping sweeping tools and vacuum equipment handy minimizes chaos if a canister tips over. Remind staff where to find safety data and spill kits; it’s easy to skip this when things get busy.
Every step in storage and handling turns seamless only when everyone buys in. Passing knowledge from senior staff to new hires, holding quick refreshers, and cataloging common missteps can save hassle. Companies with stellar safety records don’t just invest in fancy equipment—they build habits that stick. Attention to the basics earns trust, and trust supports healthier outcomes for patients down the line.
| Names | |
| Preferred IUPAC name | Iron(II,III) oxide |
| Other names |
CI Pigment Black 11 Black Iron Oxide Ferrous Ferric Oxide Iron(II,III) oxide Mars Black Fe3O4 |
| Pronunciation | /ˌaɪərn ɒkˈsaɪd blæk ˌbiːˈpiː ˌiːˈpiː ˌjuːˈɛsˈpiː ˈfɑːrmə ɡreɪd/ |
| Identifiers | |
| CAS Number | 1317-61-9 |
| Beilstein Reference | '17218' |
| ChEBI | CHEBI:37139 |
| ChEMBL | CHEMBL1201132 |
| ChemSpider | 14129 |
| DrugBank | DB11050 |
| ECHA InfoCard | ECHA InfoCard: 100.030.467 |
| EC Number | 215-277-5 |
| Gmelin Reference | Fe2O3 Fe3O4 FeO·Fe2O3 1309-38-2 1317-61-9 GMELIN 1444 |
| KEGG | C07247 |
| MeSH | D015242 |
| PubChem CID | 14452 |
| RTECS number | UN0281 |
| UNII | XM0M87F357 |
| UN number | UN3077 |
| CompTox Dashboard (EPA) | CompTox Dashboard (EPA) of product 'Iron Oxide Black BP EP USP Pharma Grade' is **DTXSID5037999** |
| Properties | |
| Chemical formula | Fe₃O₄ |
| Molar mass | 231.54 g/mol |
| Appearance | Fine black powder |
| Odor | Odorless |
| Density | 4.5 g/cm³ |
| Solubility in water | Insoluble in water |
| log P | “-10.7” |
| Vapor pressure | Negligible |
| Basicity (pKb) | 7.96 |
| Magnetic susceptibility (χ) | +2.9×10⁻³ |
| Dipole moment | The dipole moment of Iron Oxide Black BP EP USP Pharma Grade is **"0 D"**. |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 87.4 J·K⁻¹·mol⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -824.2 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -824.2 kJ/mol |
| Pharmacology | |
| ATC code | V07BB |
| Hazards | |
| Main hazards | May cause respiratory irritation. May cause eye and skin irritation. |
| GHS labelling | GHS07, GHS08, Warning, H302, H332, H373 |
| Pictograms | GHS07,GHS08,GHS09 |
| Signal word | Warning |
| Hazard statements | Hazard statements: Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008. |
| Precautionary statements | Precautionary statements: P261, P264, P271, P272, P280, P302+P352, P305+P351+P338, P304+P340, P312, P332+P313, P337+P313, P362+P364 |
| NFPA 704 (fire diamond) | Health: 1, Flammability: 0, Instability: 0, Special: - |
| Autoignition temperature | Above 1000°C |
| Lethal dose or concentration | LD50 oral rat > 5000 mg/kg |
| LD50 (median dose) | > 10,000 mg/kg (oral, rat) |
| NIOSH | 1317-61-9 |
| PEL (Permissible) | 5 mg/m3 |
| REL (Recommended) | 70 mg |
| IDLH (Immediate danger) | 2500 mg Fe/m³ |
| Related compounds | |
| Related compounds |
Iron Oxide Red Iron Oxide Yellow Iron Hydroxide Ferric Oxide Ferrous Oxide |
Chengguan District, Lanzhou, Gansu, China
