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Anhydrous Disodium Hydrogen Phosphate BP EP USP Pharma Grade: A Practical Commentary

Historical Development

Folks have turned to phosphate salts for hundreds of years, but modern medicine and industry didn't get serious about refining things like anhydrous disodium hydrogen phosphate until the push for controlled pharmaceuticals in the nineteenth and twentieth centuries. Factories changed the process from kitchen-scale boiling of animal bones to large reactors, handling thousands of tons of naturally occurring apatite rock. Tightening standards came after medical mistakes and scandals, and regulators like the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia stepped in with detailed requirements. Having worked near facilities that handled these salts, you get an appreciation for the strict paperwork, inspections, and laboratory rigidity that came with stricter standards. Sourcing shifted toward large-scale mining, and pharmaceutical purity became a must for injectable drugs and precise lab reagents.

Product Overview

Anhydrous disodium hydrogen phosphate sits among a cluster of sodium phosphate salts, but stands out because no water molecules cling to its structure. This version ensures measurement accuracy for pharmaceutics and lab kit blends. Pharmacies stocking up for parenteral nutrition and hospital setups reach for the anhydrous form, since added water throws off dosing and stability. True pharma grade demands low heavy metals, checked bacterial counts, and full traceability back to the original manufacturing run. I have seen the difference in practice: lower-grade salts throw surprise results in chemistry steps or deliver erratic pH in buffer prep, so pharma grade earns its price tag for folks who can't afford surprises.

Physical & Chemical Properties

Pure anhydrous disodium hydrogen phosphate appears as a white crystalline powder, grainy and almost gritty between the fingers if spilled from failed packaging. It easily dissolves in water, creating a clear, slightly alkaline solution. Chemists favor it because it locks in stability for buffer systems and reacts predictably without surprises from hidden moisture. Temperature changes can push it between hydrated and anhydrous forms, so storage calls for sealed drums and dry air to keep properties steady. This matters deeply for preparing IV drugs or even in the cheese and baking sectors where texture and preservative action hang in the balance.

Technical Specifications & Labeling

Pharma standards for this material cut no corners. Clear test records must show tight control on sodium and phosphate levels, absence of arsenic, lead, and microbial contamination. Each package receives a crisp batch label, with production date, retest or expiry, lot number, and links to a full certificate of analysis. Practical experience with pharma logistics drives home the headache that comes from a mislabeled drum—lost time, destroyed batches, bruised trust. The authorities inspect labels down to font size, with good manufacturing practice ensuring every sack can trace back to a documented manufacturing event. Think of it as tracking everything that could go wrong before it sneaks into a patient’s bloodstream.

Preparation Method

Manufacturers use two main processes: one starts with pure phosphoric acid and soda ash, mixed and dried, while the other begins with mined phosphate rocks, which get purified to pharmaceutical levels. Both paths involve serious chemical purification steps: filtering out calcium, magnesium, heavy metals, and then drying the solid with industrial dryers to yield the anhydrous form. Machinery must stay spotless to prevent cross-contamination—a lesson I learned after a contamination scare caused an entire day’s output to get trashed. Drum dryers, rotary ovens, and vacuum systems give chemists the control they need, but only if operators stick to compliance checks daily.

Chemical Reactions & Modifications

In the lab, anhydrous disodium hydrogen phosphate shows predictable, steady chemistry. Toss it with strong acids and you build up sodium dihydrogen phosphate or break down to phosphoric acid. Mixed with calcium salts—something common in IV nutrition—it risks precipitating out as calcium phosphate, which medical staff need to avoid in parenteral products. Phosphate ions act as solid buffers, holding pH near 8. In real pharmaceutical recipes, mistakes in combination lead to visible cloudy mixtures or lost active ingredient when the salt eats up key drug molecules. As I’ve seen, just one missed calculation during solution prep can force a whole batch back to square one, especially when incompatibilities sneak up and do not show at first glance.

Synonyms & Product Names

Scientific habits across countries and companies mean this compound comes under many aliases: Disodium hydrogen phosphate anhydrous, DSP, Sodium phosphate dibasic, and Na₂HPO₄. The names might look dry on a label, but misreading causes real-world errors when pharmacists or lab techs grab the wrong bag. Firm training with common and IUPAC names pays off, especially with global supply chains and multiple translations jockeying for attention in documentation or customs declarations. On site, workers stick with abbreviations, tossing around “dibasic” or “anhydrous DSP” to keep work moving, but always double-checking against the certificate.

Safety & Operational Standards

Solid safety routines are ironclad for working with large volumes, keeping dust out of lungs and powder off skin. Training drives home that low toxicity does not mean zero risk—spills create slippery walkways and airborne powder irritates eyes and respiratory tracts. SOPs require dust control systems and full PPE, both for workers and for the quality of the batch. Chemical storage favors cool, dry, well-ventilated rooms, and any hint of container breach prompts a quarantine. Mistakes handling the product or accidental mixing with incompatible chemicals set off alarms in production suites, so drills for chemical incidents see regular updates. Cleanup involves HEPA vacuums, lots of protective clothing, and strict recordkeeping.

Application Area

Hospitals and drug manufacturers count on anhydrous disodium hydrogen phosphate to prepare buffer solutions for IV drugs, dialysis products, and analytical chemistry kits. Food producers use it after food authorities grant specific approvals, mainly to stabilize cheese texture and improve flour blends—bakers find their dough rises better with phosphate leavening agents. Water treatment companies add it to control pipe scaling, and research labs reach for it in hundreds of chromatography and buffer prep protocols. From hospitals to classrooms, reliable phosphate supply can make or break quality control. Living near a food plant gave me a front-row seat to the food safety audits and spot inspections that come with regular phosphate use.

Research & Development

Research teams dive into new ways to apply or modify anhydrous disodium hydrogen phosphate, from tweaking manufacturing for lower carbon footprints to exploring its impact on novel drug delivery systems. Several trials assess improved blending with other excipients so clues about better solubility protocols keep appearing in industry journals. Scientists keep debating the material’s impact on long-term parenteral nutrition, especially in the pediatric nutrition space, where trace contaminants could matter over extended dosing periods. Personnel in product development labs often gather around, trading stories about that one time a new phosphate-binder unexpectedly skewed an experiment. R&D budgets continue to back safer, cheaper, and greener synthesis routes to keep up with regulatory and ecological drives.

Toxicity Research

Medical literature sets disodium hydrogen phosphate as low in toxicity for most uses, but long-term overexposure or mishandling raises red flags. Renal failure patients, in particular, run risks of phosphate buildup, so IV dosing protocols come with strict limits and double-checks. Animal studies find brief high doses irritate the GI tract, but more subtle research suggests even low levels of heavy metal contamination pose a threat during critical care usage. Investigators rarely rest easy; they look for every potential source of error in purity, pushing analytical equipment to its limits. Hospital pharmacists share stories warning of rare precipitation events in IV lines—a reminder that no ‘safe’ chemical can dodge bad handling.

Future Prospects

Phosphate resources face tough questions ahead. Mining for base material raises real sustainability issues, with environmental watchdogs keeping close tabs on waste and water use. Pharma companies now push for phosphate recycling—backing closed-loop systems inside plants and supporting research into renewable sources. In the therapeutic sector, shifting recommendations on sodium and phosphate intake nudge researchers to develop next-generation buffer salts, with potential biotech candidates already being tested in pilot studies. My conversations with regulatory professionals at conferences reveal that future rules likely mean even tighter contamination standards and more digital tracking of each lot from mine to hospital. Both food and pharma industries walk a tightrope between demanding more of this essential salt and living within environmental boundaries that keep it available for the next century.




What are the main uses of Anhydrous Disodium Hydrogen Phosphate BP EP USP Pharma Grade?

Unpacking Its Role

Anhydrous Disodium Hydrogen Phosphate isn’t a substance the average person thinks about, but in a pharmaceutical lab, you spot it in action. It acts as a buffer, holding the acidity or alkalinity of a solution steady. My earliest internship in a compounding pharmacy revealed how many formulas rely on tight control over pH. Blood replacements, antibiotics, and injectable pain relievers all ask for this kind of adjustment. Without that chemical holding things steady, you run the risk of a medicine acting oddly, breaking down, or irritating sensitive tissue.

The Backbone of Formulation

Tablets and syrups don’t simply line pharmacy shelves: Each one has to make it through months—sometimes years—of storage and rough handling. Disodium hydrogen phosphate keeps things in line among the chaos of heat, cold, and travel. It doesn’t just work alone. Often, it links up with other salts in a buffer system. Think about your favorite over-the-counter antacid or a rehydration salt pack. The formula behind it owes some stability to anhydrous disodium hydrogen phosphate.

Fine-Tuning Injections and IV Fluids

Most of my experience with this compound comes from injectable drugs. Hospitals need fluids that won’t leave patients worse off than before treatment. The right pH can be a matter of comfort or safety. Consider patients with burns, infants, or the elderly. They need solutions that won’t disrupt delicate balances. Disodium hydrogen phosphate, meeting British, European, and United States Pharmacopeia standards, finds a place here. Every batch documents its purity and trace metals so that it won’t sneak unwanted side effects into a life-saving IV drip.

Moving From Pharmacies to Labs

You’ll often see this compound on the inventory list of a diagnostic lab. Blood sample tests work best at specific pH values, and the wrong buffer causes unreliable results. Many of the blood chemistry tests, like phosphate balance checks or glucose measurements, depend on this stabilizing agent. Without it, results might mislead, pushing a doctor toward an unnecessary or unsafe therapy.

The Safety Imperative

Working with chemicals isn’t just about theory. GMP (Good Manufacturing Practice) expects every facility—pharmacy or factory—to use pharmaceutical-grade substances. Anhydrous Disodium Hydrogen Phosphate with BP, EP, or USP tags goes through tests for impurities. Heavy metals, microbial contamination, insoluble particles—each poses its own risk. Patients trust these controls every time they swallow or inject a treatment. Cutting corners is not just bad practice; it is a risk that matters.

Looking to the Future

Safety, availability, and clear documentation guide the use of every ingredient in pharmaceuticals. A simple compound, used well, smooths the way for effective, lasting treatments. Keeping training up-to-date, supporting robust supplier audits, and refusing non-pharma grade substitutes—these steps build real patient trust. The story of Anhydrous Disodium Hydrogen Phosphate is a reminder that even the “boring” ingredients matter just as much as the active drugs in our medicine cabinets.

What is the chemical formula and CAS number for this product?

Understanding What’s in the Package

Curiosity kicks in whenever a new chemical product arrives at a workplace or even at home. A label listing an unfamiliar compound feels like the tip of the iceberg. Beneath the surface lies the real story—a chemical formula and a CAS number. These two details speak volumes about the substance's properties, risks, and the responsibilities tied to using it.

Seeing Beyond a Name

A product’s trade name might sound technical or even reassuring, but that name alone rarely gets you far. Years of working in manufacturing taught me that two products could target the same job but contain completely different compounds. The chemical formula strips away branding to reveal the exact arrangement of atoms. Whether working with sodium chloride (NaCl) for food or sodium hydroxide (NaOH) for cleaning, that small difference in letters means something very different on your skin, on metal, or if a spill happens.

CAS Number: Why It Matters

No two databases catalog chemicals the same way. Spelling, language, or regional quirks create confusion fast. The Chemical Abstracts Service Number, or CAS number, never changes, no matter what a product is called in Germany or China or South America. For example, acetone always carries the CAS number 67-64-1, whether you buy it in a small hardware store or receive an industrial drum at a factory. Looking up the CAS number opens access to safety data sheets, toxicology studies, and official regulatory guidance. I once dodged a hazardous incident in a warehouse because someone had flagged the correct CAS number during a routine inventory check, helping us identify an incompatible storage arrangement before anything could go wrong.

Staying Safe and Compliant

Regulators take no chances. Occupational health and safety rules, fire codes, and environmental standards all rely on precise chemical identification. For instance, storing ammonium nitrate (CAS 6484-52-2)—a fertilizer component but also a potential explosive—falls under strict local and international laws. These laws don’t go by pretty packaging or local slang; they cite chemical formulas and CAS numbers. Without these, employees face increased risks, and companies expose themselves to fines, shutdowns, or worse. Experience in compliance has shown me that getting even one digit wrong can mean a visit from inspectors, lost workdays, and expensive cleanup.

Making Better Decisions With Facts

Information brings power to act responsibly. If a supplier refuses to give a CAS number or only lists a vague name, alarms start ringing. The ability to look up a product by formula or CAS number lets buyers avoid counterfeits, spot hidden dangers, or compare quality between brands. The more someone interacts with the technical details, the stronger their instinct grows for sniffing out deals that seem too good to be true. Over time, I found myself double-checking product sheets before accepting deliveries, often catching discrepancies that led to better buying decisions and safer outcomes for colleagues and equipment.

Bridging the Gap With Solutions

Getting chemical formulas and CAS numbers shouldn’t be a struggle. Suppliers who invest in transparent labeling, accessible safety information, and responsive support create trust. Digital inventory systems that let you search by CAS number or formula—not just a product name—keep everyone honest and efficient. Training workers to understand what those details mean pays significant dividends in uptime, safety, and confidence. Strong information culture stands between a routine workday and an emergency. It doesn’t just protect people; it keeps supply chains running smoothly and builds a reputation grounded in reliability.

Is this product suitable for use in pharmaceutical formulations?

Formulations in the pharmaceutical world ask a lot from every ingredient. If you're looking at a new raw material or excipient, several questions come up: Does it interact safely with active ingredients, does it go through regulatory hoops, and can it reliably keep a batch stable across months of shelf life?

Building Trust Through Transparency and Track Record

Any material under consideration must have a clear record of safety. Regulatory agencies expect supporting evidence, not just claims. When working in product development, I’ve often relied on published toxicological studies and supplier data sheets. Some compounds look promising on paper but fall short under scrutiny. For example, chemical impurities sometimes trigger allergies, or interact with active drug molecules, undermining a medicine’s stability. Reliable products won't have gaps in their Certificates of Analysis and will be traceable to their origin, with full details on their synthesis or extraction. If that transparency isn’t there, it’s tough to move forward with confidence.

Physical Properties Matter on the Production Floor

Years in manufacturing taught me that lab-scale success doesn’t always translate to the real world. I remember a tablet project that hit a roadblock because a new excipient clumped up in the mixer, leading to uneven tablets. Flowability, moisture content, and particle size count—details often overlooked. The best material doesn’t just pass the chemistry test. It also cooperates with existing machinery, making daily production possible without costly retooling or endless troubleshooting.

Consistency Is Key for Every Batch

Pharmaceuticals don’t get room for error. A single metric out of range can hold up a shipment or spark a recall. Consistency lets companies produce medicine that matches label claims from every batch. For me, trust builds only after repeatedly seeing identical specs and performance reports. Some suppliers try to lure buyers with one-time deals, but a solid partnership depends on reliable inventory and steady quality. Unexpected changes in raw materials are rarely worth the risk, especially when patient safety is part of the equation.

Regulatory Approval Makes or Breaks a Product

No product can go into a pharmaceutical blend without regulatory clearance. In my own work, even minor formulation tweaks often double approval times. Regulatory bodies look for documented safety, batch-to-batch consistency, and proof of good manufacturing practice. Firms also review something called pharmacopeial status—whether a compendium like the USP or Ph. Eur. recognizes the substance and spells out acceptable limits for contaminants. Details such as heavy metals, residual solvents, and microbial counts come under scrutiny. A candidate missing from these lists faces an uphill climb, potentially adding years and significant cost to the project. I’ve seen promising materials shelved simply because they didn’t fit the current regulatory puzzle.

Solutions: Due Diligence and Supplier Partnerships

Moving toward a suitable, approved product means assembling the right team. Lab scientists can vet purity and function, while regulatory affairs professionals dig through documentation and legal standards. Direct conversation with suppliers helps, especially if on-site audits are possible. My best results came from suppliers willing to share manufacturing details, test samples alongside my team, and pivot quickly if an issue surfaced. Every step builds the foundation for safer, more effective medicine, and shorter time-to-market for a new therapy.

How should Anhydrous Disodium Hydrogen Phosphate be stored and handled?

A Material with Unique Risks

Anhydrous Disodium Hydrogen Phosphate, found in labs across the world, sounds like just another white powder. In reality, this chemical offers benefits in everything from food processing to water treatment and lab analysis. But handling it without respect for its properties? That’s where small mistakes snowball into bigger problems. This isn’t table salt. Improper storage and careless handling can lead to contamination, ruined results, or even potential health hazards.

Safe Storage: Far Beyond the Shelf

Experience in the lab teaches one lesson quickly: chemicals never cut corners, so neither can we. Anhydrous Disodium Hydrogen Phosphate stays stable, but moisture turns it clumpy and changes its composition. I always store it in tightly sealed containers—polyethylene works well. Once, a colleague left a jar open overnight. By morning, humidity from the air had caked the powder, throwing off his measurements and delaying the work of the entire team.

Labels matter. Clear, printed names with the date of receipt tell us how old the product is and prevent confusion. Keeping the material off the ground avoids water or accidental spills during cleaning. Placing it on a shelf with low traffic reduces chances for accidental bumps or exposure. Chemicals thrive on patterns—a neat, organized area beats a cluttered bench any day. Temperature control also plays a role: I never store it near heat sources or under direct sunlight, since these can degrade quality over time. Most storage rooms keep to a cool, dry setup, which helps keep the chemical in its anhydrous state.

Sensible Handling: Protecting People and Results

Years of lab work have shown that a little preparation makes everyone safer. Gloves, safety goggles, and a dust mask form the standard shield when measuring out this material. Accidents can sneak up—a quick sneeze in front of an open jar sends a light cloud of powder across the room. Proper personal protective equipment stops inhalation or skin irritation right away.

Spills will happen. It only takes a second of distraction. In my lab, we keep a designated plastic dustpan and brush for these cases—never use water, since this changes the powder’s properties and, in food and pharma settings, risks contamination. Always sweep up gently and dispose of residue in a chemical waste bin, not the regular trash. This is a common-sense step, but even seasoned professionals can get lazy under pressure. Respecting even the simplest cleanup procedures keeps everyone out of trouble.

Why Regular Checks Pay Off

Building in routine audits prevents costly surprises. Every couple of months, I scan through chemical stores to check for leaky containers or outdated stock. Any jar showing clumps or discoloration goes straight to the disposal pile. This also applies to our safety signage—label fading or missing hazard warnings set the stage for forgetfulness.

Vigilance extends to documentation. Detailed logs show batch numbers, supplier details, and expiry dates. Whenever someone new starts in the lab, I walk through these records, making sure the whole team understands what’s in the room and why it matters. This focus on transparency doesn’t just tick a regulatory box; it has prevented plenty of close calls over the years.

Investing in Health and Precision

Storing and handling chemicals like Anhydrous Disodium Hydrogen Phosphate with care supports trust in the work and the wellbeing of anyone around. No shortcut beats a mindset of preparation and a clear commitment to quality. Every bag and bottle—just like every project—deserves the right environment and full attention to detail, from delivery to disposal.

What are the available packaging sizes for this pharma grade chemical?

Direct Answers and Real-World Relevance

In the pharmaceutical industry, chemical packaging determines more than just shelf space. It shapes transport costs and how safely teams can handle materials. Common packaging sizes seen today run from compact 500-gram bottles up to multi-kilogram drums. At the lower end, there’s the 1 kg HDPE bottle. Many labs stick to these because they’re easy to store, move, and use for small-batch processes. I recall countless days in my first lab job, moving boxes of these secure containers, knowing a spill from one of them could still cause issues, but far less so compared to a drum.

Larger-scale operations look for bulk. Here, suppliers offer 5 kg and 10 kg containers, usually made from high-density polyethylene or stainless steel. These stand up to both transit and storage risks better than glass or lighter plastics. Demand for 25 kg fiber drums or HDPE barrels isn’t rare; these suit manufacturers cranking out high quantities of tablets, capsules, or other dosage forms each week. The big 50 kg drums or bags usually come into play at full-scale manufacturing plants or ingredient blending centers. You won’t find these sizes down the hall in a research lab — they’re designed for forklifts and warehouse pallets, not counter tops.

Safety, Compliance, and Practicality

Every packaging size comes with strict guidelines. Regulatory agencies won’t budge if a drum label or tamper-evident seal falls short. Pharma chemicals, especially actives and excipients, often require double or even triple containment systems. I’ve seen packaging that uses inner liners sealed with tie wraps, then packed within rigid drums and shrink-wrapped — a level of precaution learned from hard experience rather than from reading protocols. This tight control traces back to safety, integrity, and compliance. Fines loom for companies that treat these rules like suggestions.

For certain moisture-sensitive or volatile chemicals, even 1 kg containers include desiccants or nitrogen-flushed liners. This isn’t luxury — a single dose failure can trigger a recall, denting both finances and reputation. Bigger drums add new headaches: static discharge risks, spillage, and ergonomic strains. Training staff to handle 50 kg drums safely can feel like its own project. Solutions often include better lifting equipment, clear hazard labels, and more hands-on safety briefings.

Sustainability and Future Trends

While strict rules remain in place, customers ask more about recyclability and waste. Multi-use containers like stainless steel drums are coming back strong, especially where companies manage closed-loop collection systems. Smaller bottles now sometimes feature recycled materials, lowering the environmental blow without trading away chemical stability. There’s ongoing push for smart labels and RFID tracking, making it easier to follow chemicals from plant to patient — one scan removes guesswork on where, when, and who handled a batch.

Suppliers who listen to feedback keep refining packaging sizes and designs, too. It makes sense: nobody wants to pay surplus fees shipping 20 kg in a 50 kg drum. Pharmacies and compounding centers often prefer the flexibility of several 1 kg bottles over a single monster drum. At a big contract manufacturer, it helps to split shipments into several mid-sized drums, improving traceability while reducing manual lifting risks.

Final Thoughts

Available packaging sizes have shifted from tradition to practicality, shaped by regulation, workflow, and safety. Whether it’s glass, HDPE, stainless steel, or something new, the chemical’s purpose, local laws, and end-user needs all drive what makes the cut — and what gets left on the supplier’s shelf.

Anhydrous Disodium Hydrogen Phosphate BP EP USP Pharma Grade
Identifiers
CAS Number [7558-79-4]
Gmelin Reference 52976