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The story of dipotassium hydrogen phosphate stretches back over a century. Chemists worked on potassium salts long before the pharmaceutical industry came into its own. In the early days, uses focused on agriculture and laboratories, but as drug formulations became more advanced, the demand for high-purity excipients pushed development further. The introduction of British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) standards reflected the drive for global consistency. Over the decades, changes in purification technologies and regulatory approaches led to more efficient production with lower contamination risks, which had a direct effect on product reliability in medicine and food.
Dipotassium hydrogen phosphate, also known as potassium phosphate dibasic, turns up in pharmaceutical manufacturing as a buffering agent, electrolyte replenisher, and nutrient. Its simple formula, K2HPO4, represents a potassium salt of phosphoric acid. Chemists and manufacturers look for consistent appearance—white, crystalline powder, quickly soluble in water and nearly insoluble in alcohol. Reliable supply allows for dependable integration into injectable and oral dosage forms. Drug manufacturers yield to the high benchmarks set by BP, EP, and USP monographs, knowing that the smallest variation can change a batch’s safety profile.
This salt’s greatest asset may be its physical predictability. Dipotassium hydrogen phosphate melts at about 340°C with decomposition, exhibits high solubility in water, and stable pH buffer action between 8.5 and 9.5. Its chemical structure features orthophosphate with potassium cations bound ionically. Many in the industry choose it over sodium alternatives because of potassium’s physiological role in the human body—the body uses potassium for heart and muscle function, which makes this salt less problematic in treatments for sensitive patients. Analytical tests confirm purity by tracing all possible contaminants, including heavy metals and sodium.
Quality assurance teams use technical sheets to confirm grade claims before purchase. These documents list appearance, assay percentage (usually 98–100.5%), water content, pH, chloride, sulphate, and arsenic content. Packet labeling demands traceability for every batch; names, grades, lot numbers, expiry, manufacturer identify, and storage recommendations appear on all containers. In my experience, the best manufacturers provide full documentation, including certificates of analysis and compliance statements to let buyers audit every step back to source materials.
Producers create dipotassium hydrogen phosphate by neutralizing phosphoric acid with potassium carbonate or potassium hydroxide, then purifying and crystallizing the result. In industrial operations, water quality matters as much as raw input—high purity water helps maintain compliance when the intended use falls under pharmaceutical or food categories. Crystallization at controlled temperatures keeps particle size predictable. Each site develops its process validation trails, but successful operations routinely use closed reactors and stainless steel contact surfaces to avoid trace metal leaching, which can slip past less rigorous protocols.
This phosphate salt stands up well in most pH zones, though strong acid can break it down to form monopotassium phosphate. Heating above its decomposition temperature triggers phosphoric acid release and potassium oxide formation. Combinations with calcium salts yield precipitates, helping researchers study mineralization or simulate physiological precipitation in bone research. Chemical engineers sometimes modify the crystalline form by controlling evaporation rates or seeding, though the standard dihydrate and anhydrous forms cover most pharmaceutical requirements. These possibilities for transformation have influenced new drug delivery techniques and sustained-release dosage forms.
People in the field learn the myriad names for this compound—potassium phosphate dibasic, dipotassium phosphate, and secondary potassium phosphate are the usual suspects. Drug formularies and chemical catalogs streamline these names based on application. International trade demands harmonized terminology, so packaging follows the IUPAC designation and local language equivalents. The number of synonyms sometimes confuses less-experienced handlers. This increases the need for careful cross-checking between specification sheets and labeling to prevent substitution errors that can slip into pharmaceutical compounding.
Safe handling of dipotassium hydrogen phosphate focuses on dust reduction and personal protective equipment. While considered low-hazard, inhaling fine powder can irritate airways. Gloves and goggles are standard, and larger facilities move toward automated measuring and closed dispensing systems. Key regulatory standards stem from REACH, OSHA, and those set by each pharmacopoeia. Food and pharmaceutical audits can demand cleaning validation and environmental monitoring data. The best plants employ regular surface sampling, air particle counting, and operator training to prevent cross-contamination and unintentional exposure.
Pharmaceutical companies turn to this substance mainly as a buffer in parenterals, tablets, and suspensions, where narrow pH ranges determine stability and absorption. Electrolyte replenishment for patients with hypokalemia benefits from potassium’s compatibility, and liquid food supplements benefit from its solubility. Its nutrient role supports some fermentation processes, including in the biotechnology industry. I’ve watched researchers use dipotassium hydrogen phosphate to support cell cultures for vaccine production and to tweak bioavailability in slow-release tablets. Food processors depend on it for emulsification and sequestration rather than just flavor control.
Innovation in dipotassium hydrogen phosphate continues. Drug formulators push to discover new uses in stabilizing protein drugs or optimizing freeze-dried vaccines. Studies have measured its behavior in polyphasic mixtures, targeting wound care and topical gels. A few research teams experiment with micro- and nanoparticle versions to unlock unusual bioavailability or targeted transport, especially in cancer therapeutics. Universities continue to review its interaction with other excipients in search of better pharmacokinetics, determined to identify every speed bump in patient safety.
Toxicology studies on dipotassium hydrogen phosphate paint a reassuring picture at approved dosages. Testing in animal models and clinical studies shows low acute toxicity and minor gastrointestinal symptoms at high intake. Chronic exposure rarely leads to organ damage unless existing kidney, antacid use, or potassium imbalances come into play. Global regulatory agencies—from the FDA to EMA and China’s NMPA—keep setting maximum allowable limits for intake and monitor published updates to safety data linked to rare metabolic or allergic reactions.
Demand for high-quality excipients rises as precision medicine becomes mainstream. Dipotassium hydrogen phosphate stands poised for greater use thanks to advances in analytical chemistry. Automated dosing, closed-system compounding, and green chemistry production methods cut waste, push for greater purity, and promise lower environmental impacts. Future product lines may include tailored grades for biologics and orphan drugs. Pharmaceutical processors will keep watching for novel crystalline forms, improved trace contaminant management, and fresh safety data driven by health tech’s evolution.
Dipotassium hydrogen phosphate comes with a name that feels like a chemistry test, but in reality, it’s a white, salty-tasting powder you’ll find on ingredient lists in both food and medicines. Pharmaceutical suppliers use BP, EP, or USP standards to confirm its quality for medicine, which means this stuff meets some of the strictest regulations. The short answer to what it’s for: balancing pH, keeping medicines stable, and sometimes even helping your body replace lost electrolytes.
Making medicines is more than just mixing chemicals. Every ingredient has a job, and dipotassium hydrogen phosphate stands out as a pH adjuster. Many active drugs react to changes in acidity; get the mix wrong and you risk a pill that breaks down too soon, a liquid medicine that tastes funny, or a solution that stings. This compound brings predictability, giving pharmacists control over how quickly the body absorbs a drug or how comfortable it feels going through an IV.
People don’t just want their medicine to work—they want it to be safe, whether they’re swallowing a tablet or getting an injection. Pharmaceutical grade dipotassium hydrogen phosphate goes through a higher level of testing for purity. No traces of heavy metals, no mystery particles, nothing extra. Bad batches end up in recalls, missed treatments, or worse. Sticking to BP, EP, or USP grade keeps those risks out of the pharmacy and away from the patient.
Everyone knows electrolytes matter when you get dehydrated. Hospitals rely on this phosphate variant for intravenous (IV) fluids and oral rehydration solutions. It helps the body hold onto water and rebuild what’s lost from sweat, diarrhea, or kidney problems. Potassium, in particular, plays a role in heart function and muscle health. An imbalance lands people in emergency rooms, so having a reliable, well-regulated source makes a difference in outcomes.
Big pharma companies keep supply chains locked tight, but hiccups happen. Natural disasters, factory shutdowns, or political issues can slow access to crucial chemicals. An interruption in a supply of something like dipotassium hydrogen phosphate causes delays rippling across production lines. This isn’t a household ingredient, so running out means fewer bags of IV fluids or delays at the pharmacy. Industry groups and regulators keep close tabs to prepare for shortages and speed up imports when needed.
It helps when governments work with manufacturers and hospitals to monitor inventory levels. Some countries even keep emergency stockpiles of common drug ingredients, dipotassium hydrogen phosphate included. Transparency about where supplies are sourced and how they’re tested builds trust for both professionals and patients. Drugmakers who publish quality data and test results give clinicians confidence to prescribe, and patients peace of mind to take what’s offered.
It’s easy to overlook simple ingredients in complicated medicine, but these chemistry building blocks shape how quickly you recover, how sick you feel, and how safe a treatment is. Years working alongside pharmacy teams showed me just how much effort goes into sourcing every single batch—cutting corners costs lives. Pharma-grade dipotassium hydrogen phosphate isn’t flashy, but its role proves essential every time a nurse hangs up a drip or a child swallows a rehydration packet.
Dipotassium hydrogen phosphate, also known as potassium phosphate dibasic, holds a key role in pharmaceutical manufacturing. You see this substance used as a buffering agent, helping to keep pH levels just right during the formulation process. Many IV fluids, oral medications, and diagnostics rely on its consistency and purity, which can mean the difference between successful treatment and questionable results.
Pharma-grade dipotassium hydrogen phosphate comes with tight specifications. This isn't just about meeting a chemical formula on paper; it’s about controlling everything from solubility to particle size. The assay matters—a pharma batch typically contains between 98% and 100.5% of the potassium phosphate dibasic, measured by dry basis. This level ensures patients get the intended dose and that drugs mix properly, not leaving behind undissolved bits that could harm patients or clog devices.
Manufacturers pay attention to physical cues. The powder should be white and non-lumpy. Moisture must stay below 1% by weight. High moisture opens the door for clumping and microbial growth, both of which threaten safety. Insoluble matter gets checked, usually limited to under 0.2%. Sometimes I get questions about why slight deviations matter; one contaminated vial can create a recall and put health at risk for thousands. Purity in this context isn’t academic—it’s the shield between reliable medicine and a trust crisis.
Pharma grade materials often get tested for heavy metals. Limits run as low as 10 parts per million for substances like lead, cadmium, or arsenic. Even in tiny quantities, heavy metals build up in the body over time. That’s why most quality labs run multiple tests on each production lot, sometimes even with third-party verification. Microbial limits also matter—bacteria and molds must stay well below specified thresholds, sometimes even at “not detected” levels. These numbers come from hard medical experience; contaminated products have caused too many hospital outbreaks in the past.
Chloride, sulfate, and carbonate levels are watched closely. This relates to the base salt, but also to the equipment and water used during synthesis and packaging. Chloride must often stay under 200 ppm, sulfates below 150 ppm. Carbonates get flagged if seen at all. I’ve seen situations where a simple filter change brought down contamination by half. It’s these small operational choices that protect patients every day.
Global supply chains present new pressure points. Not every supplier follows the same standards, and differences in water quality or equipment can creep into the finished powder. Pharmaceutical companies work with pre-approved suppliers, plus regular audits and audits before accepting a new source. I’ve walked plant floors where constant monitoring hums in the background—every shift tracking pH, conductivity, and microbial plates. It’s a quiet, determined vigilance, not bureaucracy for its own sake.
Keeping specifications tight means investing both in testing and in staff training. Instruments alone can’t spot problems if the people running them don’t notice trends or odd results. Companies that invest in continuous learning tend to catch issues early. Investing in robust supplier relationships brings about trust and accountability on both sides; quick communication about quality issues helps everyone make safer medicines.
At the end of the day, purity and strict adherence to specifications keep therapies safe. Pharmaceutical teams can’t afford shortcuts. Every tablet, injection, and solution made with dipotassium hydrogen phosphate depends on these “boring” numbers being spot-on, batch after batch.
People don’t often think much about the excipients in medicines, but every ingredient matters. Take dipotassium hydrogen phosphate: it supports stability, adjusts pH, and helps deliver active compounds where they need to go. In my experience working with health science literature, if you care about the details, you notice how this phosphate salt keeps coming up—especially in injectable preparations, dialysis fluids, and nutritional formulas.
Regulatory bodies like the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) don’t just hand out certifications. Their standards call for ingredient purity, precise manufacturing, and strict control over contaminants. Dipotassium hydrogen phosphate that meets these benchmarks can be traced, batch by batch, down to the tiniest impurity. These monographs include detailed limits for heavy metals, microbial growth, and elemental impurities that could harm patients.
Potassium itself plays a huge part in human health. The body relies on it every day, but too much or impurities in a formulation can cause problems. The BP EP USP grades spell out specifications—restricted sodium, limited arsenic, and clear water content. Reputable manufacturers analyze batches before release using validated methods, not just spot checks. Quality teams will reject a lot that doesn't tick every box.
In the wrong hands, even an approved ingredient can create trouble. If a supplier cuts corners or stores material improperly, unexpected degradation products, microbial contamination, or cross-contamination can sneak in. What’s on the label doesn’t guarantee what’s inside. Genuine risks include accidental exposure to metal shavings from old machinery or improper dosing of potassium itself—especially for patients with kidney conditions. Documented recalls in the pharmaceutical supply chain remind everyone that supply chain visibility matters.
I’ve read medical case reports where bulk chemicals sold outside regulated channels caused severe reactions. Licensed suppliers who meet pharmacopoeial standards use proper equipment, keep detailed records, and follow recall processes. Off-spec phosphate salts—sold for agriculture or industrial uses—end up in some “gray market” products, risking patient safety.
Every health system faces the temptation to cut costs. The solution starts with respecting the audit trail: source raw materials from trusted suppliers who provide full documentation and undergo regular third-party inspections. Testing doesn’t just end at the point of manufacture—every shipment into a drug factory goes through further analysis. Hospitals and pharmaceutical firms need a system to track ingredient lot numbers and quickly pull anything suspicious off shelves.
Education reaches beyond the lab. Doctors, pharmacists, and even patients benefit from transparency about where medicines are made and what’s inside. Pharmacists should have easy access to information about ingredient grades. Tech advances, such as blockchain tracking or QR code verification, offer promise for exposing counterfeiters. Governments and regulators play a key role in keeping standards up-to-date and policing the global market.
Dipotassium hydrogen phosphate—when sourced and handled according to BP, EP, or USP standards—remains an established, practical component in medicines worldwide. The biggest safeguard always comes from vigilance at every step: sourcing, analyzing, transporting, and storing. My own belief, informed by years sifting through drug safety reports, is that knowledge and constant questioning work better than trust alone. If patients and providers keep asking where each ingredient comes from, companies and regulators feel the pressure to do better.
Dipotassium hydrogen phosphate sounds like chemistry class, but in pharmaceutical circles this salt plays a crucial role. Labs and production facilities rely on its high purity, whether making injectables or prepping buffer solutions. Keeping this compound in top-notch condition is no side note, since contamination or degradation can turn a reliable ingredient into a liability.
Not all chemicals demand the same level of care, but dipotassium hydrogen phosphate deserves respect. From my own years around chemical stock rooms and GMP-compliant manufacturing lines, the difference between a batch that’s been looked after and one that’s been forgotten on a damp shelf stands out. Moisture, heat, dust — these slip-ups add up.
This salt draws water from the air. Clumping, caking, or even dissolving into a watery mess can crop up if the container stays open or humidity drifts high. Picture a corner in an old warehouse, summer heat pressing in and AC lagging behind. It doesn’t take long before a once-dry powder refuses to pour from its drum, making dosing unpredictable and quality checks fail.
Dry, well-ventilated storage cuts down on these risks. I’ve seen the difference clear: walk into a room where temperature and relative humidity hover in the low range — ideally below 25°C, with humidity less than 60%. Giant desiccator units hum softly, and staff avoid opening bins more than needed. That orderliness keeps the product flow smooth and reduces waste.
Some forget that bags, barrels, or bins aren’t just transport options, but shields against contamination. Plastic liners go in first, then tight-sealing lids follow. I’ve dealt with bags left half-tied, and it never ends well — an off odor, or visible specks that mean a full batch goes in the disposal bin rather than to the blending line.
Labels matter too. Mixing up ingredients can be disastrous, so every drum gets a clear product name, batch number, and expiry. In regulated settings, these seem basic but keep auditors satisfied and staff confident about what they’re using.
Some might gloss over where chemicals are parked. I’ve seen storerooms jammed next to janitorial closets or under plumbing. Water comes in, dirt follows, perhaps even the wrong fumes. A well-kept warehouse separates acids and alkalis, keeps cleaning agents on a different shelf, and limits who can enter. Fewer surprises land on your desk that way.
Even the sturdiest packaging and cleverest system gets old. Regular walk-throughs help catch damaged containers, leaks, or temperature slips before they become big problems. Staff know not to shove bags right up against heating vents or windows. Thorough onboarding and refreshers help keep these details alive, so no one grabs a scooper with last week’s residue and cross-taints a batch.
Many facilities could do better with automated climate control, more frequent checks, or better container materials. A culture of ownership and regular maintenance goes a long way. That diligence becomes part of the recipe — not just for dipotassium hydrogen phosphate, but for every critical ingredient on the shelf.
Pharmaceutical ingredients pack much more into their packaging choices than meets the eye. Dipotassium hydrogen phosphate, often called K2HPO4, carries a vital role as a buffering agent and nutrient in both drug formulations and laboratory work. For the BP, EP, and USP grades (which refer to British, European, and United States Pharmacopoeia standards), manufacturers typically stick to packaging that suits careful handling, meets quality expectations, and keeps things efficient for both large and small buyers.
In my years on the manufacturing side, I saw suppliers turn to reliable standards. The 25-kilogram fiber drum or poly-lined bag stands out as the go-to package. This size balances ease of lifting, storage constraints in pharmaceutical sites, and the risks of moisture contamination. The pail or drum is sturdy, stackable, and roomy enough to handle most production needs but light enough to avoid the pains of maneuvering industrial super sacks with every order.
In larger pharmaceutical factories, you can spot 50-kilogram drums on the receiving dock, but that’s usually for massive batch work or when the plant moves through bulk chemicals at a strong pace. For labs, quality control rooms, or smaller-scale compounding, 1-kilogram and 5-kilogram plastic jugs or high-density bottles cover the essentials. Nobody wants to break the bank by buying a huge drum just to leave half of it sitting unused, exposed to the air.
Choosing package sizes is more than copying an old template. Pharmacopoeia grades demand strict attention to purity and traceability. Poor repackaging can compromise the chemical, affecting solubility and shelf life, which in turn complicates regulatory compliance. Firms stick with original supplier packaging—sealed, tamper-proof, and labeled with batch and expiry details—so nothing gets lost in the shuffle. Regular audits bring headaches if there’s doubt about the chemical’s identity and history, so clear labels and firm seals on each size cut down on compliance risk.
Pharma-grade dipotassium hydrogen phosphate doesn’t travel the same way as fertiliser-grade. I’ve watched teams stress over keeping moisture out because hygroscopic powders clump quickly. Paper-wrapped bags don’t make sense; poly-lined drums offer a nearly airtight solution. The drums stack safely on pallets, roll down corridors, and open up with minimal dust, saving time and avoiding costly spills. Smaller bottles for lab work cut exposure every time a scoop gets taken out, reducing degradation and dosing errors.
When supply chains run close to the bone, standard sizes prevent expensive surprises. A buyer can swap between vendors if both agree on the same package specs. Smaller volumes cost a bit more but save big on waste and keep expiration dates in check, especially if the operation doesn’t use metric tons each quarter.
Today, more buyers are asking about biodegradable bags and containers that can handle the rigors of pharmaceutical materials. The market responds slowly, weighed down by strict standards and the need for clean room compatibility. Bulk buyers run experiments with reusable lined drums, but adoption happens only if cost, contamination risk, and supplier certification line up. In the meantime, the old drum-and-bag pairing stays popular because it offers a time-tested mix of safety, practicality, and convenience.
In the end, picking the right packaging for K2HPO4 isn’t just about tomorrow’s shipment. It's part of a bigger puzzle about safety, efficiency, and meeting the relentless standards of global pharma production.
| Names | |
| Preferred IUPAC name | Dipotassium hydrogen phosphate |
| Other names |
Dipotassium phosphate Potassium phosphate dibasic Dibasic potassium phosphate DKP Potassium hydrogen phosphate Phosphoric acid, dipotassium salt |
| Pronunciation | /daɪ.pəˈtæs.i.əm ˈhaɪ.drə.dʒən fəˈs.feɪt/ |
| Identifiers | |
| CAS Number | 7758-11-4 |
| Beilstein Reference | 3561345 |
| ChEBI | CHEBI:7756 |
| ChEMBL | CHEMBL1201780 |
| ChemSpider | 93414 |
| DrugBank | DB09449 |
| ECHA InfoCard | 03-2119969286-37-XXXX |
| EC Number | 231-834-5 |
| Gmelin Reference | 12848 |
| KEGG | C00377 |
| MeSH | Dipotassium Phosphate |
| PubChem CID | 516951 |
| RTECS number | TC6615500 |
| UNII | VHL598522R |
| UN number | UN 9149 |
| CompTox Dashboard (EPA) | DTXSID5020406 |
| Properties | |
| Chemical formula | K2HPO4 |
| Molar mass | 174.18 g/mol |
| Appearance | White or almost white crystalline powder |
| Odor | Odorless |
| Density | 2.44 g/cm³ |
| Solubility in water | freely soluble in water |
| log P | -4.1 |
| Vapor pressure | Negligible |
| Acidity (pKa) | 7.2 |
| Basicity (pKb) | 11.8 |
| Magnetic susceptibility (χ) | -22.0×10⁻⁶ cm³/mol |
| Refractive index (nD) | 1.335 |
| Dipole moment | 0 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 212.1 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -2046 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -2950 kJ/mol |
| Pharmacology | |
| ATC code | B05XA07 |
| Hazards | |
| Main hazards | May cause irritation to eyes, skin, and respiratory tract. |
| GHS labelling | GHS07, GHS Hazard Statement: H319, GHS Precautionary Statement: P264, P280, P305+P351+P338, P337+P313 |
| Pictograms | GHS07,GHS09 |
| Signal word | No signal word |
| Hazard statements | Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008. |
| Precautionary statements | P264, P270, P301+P312, P305+P351+P338, P337+P313 |
| NFPA 704 (fire diamond) | 1-0-0 |
| Explosive limits | Non-explosive |
| Lethal dose or concentration | LD50 (Oral, Rat): > 5,000 mg/kg |
| LD50 (median dose) | Oral LD50 (rat): 17000 mg/kg |
| NIOSH | WA190 |
| PEL (Permissible) | 10 mg/m³ |
| REL (Recommended) | 50 mg/kg body weight |
| IDLH (Immediate danger) | Not listed |
| Related compounds | |
| Related compounds |
Monopotassium phosphate Tripotassium phosphate Dipotassium phosphate Potassium dihydrogen phosphate Sodium phosphate Potassium chloride |
Chengguan District, Lanzhou, Gansu, China
