Chengguan District, Lanzhou, Gansu, China sales01@liwei-chem.com 1557459043@qq.com
Follow us:



Dicalcium Phosphate Dihydrate BP EP USP Pharma Grade: Description, Qualities, and Relevance

What is Dicalcium Phosphate Dihydrate BP EP USP Pharma Grade?

Dicalcium phosphate dihydrate, known to many in labs and factories as CaHPO4·2H2O, comes as a white crystalline solid, notable by CAS number 7789-77-7 and typically carrying the HS Code 28352500. In the world of pharmaceutical excipients, Dicalcium Phosphate Dihydrate BP EP USP Pharma Grade operates at the intersection of reliability and chemical safety. Inside a bag of this material, you see free-flowing white powder or sometimes flakes, a substance neither toxic nor reactive under normal handling. Reliable density—about 2.31 g/cm³—helps with accurate measurement, while its ability to dissolve slightly in water but not in alcohol makes it easy to filter out from liquid mixtures. The crystalline nature keeps this compound stable and easy to use in tableting, a practice that has helped modern pharma companies ensure that ingredients don't clump together or cause unpredictable changes in pills or tablets. Across industries from food processing to agriculture, the same crystal structure carries through, offering consistent results batch after batch.

Chemical Structure and Formula

You find Dicalcium Phosphate Dihydrate in a compound that marries calcium, hydrogen phosphate, and two water molecules: its molecular formula reads as CaHPO4·2H2O, with a molar mass of 172.09 g/mol. The structure, built of ionic bonds between calcium ions and phosphate groups, brings two molecules of water into the lattice, which keeps the powder stable during storage and transportation. These physical and chemical traits matter because they pave the way for safe use in oral pharmaceutical forms, where breakdown in water inside the human body becomes predictable. Analytical data show purity standards that approach or exceed 98%, putting it among the more reliable raw materials for pharma and food production. Each batch goes through X-ray diffraction tests to confirm the dihydrate phase, as well as thorough titration to check calcium and phosphate percentages, in line with USP, BP, and EP standards.

Physical Properties, Appearance, and Specifications

Whether you hold a handful of Dicalcium Phosphate Dihydrate powder or scoop it from a drum in its crystalline form, you notice stability in bulk. Its off-white to pure white color hints at minimal contamination, and the product sheds dust only reluctantly, an indicator of tight control in production. PH measurements in a water suspension usually settle between 6.5 and 8.5, keeping the compound compatible with a range of actives and excipients. Moisture content sits at or below 20%, helping avoid caking during storage. And while the powder form dominates the market, this compound also shows up as flakes, crystalline pearls, and, in rare cases, a slurry form for industrial slurry-based applications. No liquid or solution forms exist on the commercial (pharma) scale, since solubility stays low—about 0.03 g in 100 mL of water at room temperature. Particle sizing, a major concern in compression and blending, stays finely controlled, falling in the 100-300 µm range, to reduce risks like segregation or dust explosions. Each container lists batch details, expiration date, and traceability info, supporting GMP compliance and regulatory audits.

Safety, Hazard, and Handling

Unlike many other inorganic phosphates, Dicalcium Phosphate Dihydrate wins points among safety officers and production supervisors for its gentle profile. No significant risks accompany handling, though dust generation gets monitored, since sensitive workers can occasionally experience mild respiratory discomfort. Standard protective gear—masks, gloves, and goggles—takes care of routine risks. No cases of mutagenicity or carcinogenicity have showed up in long-term studies, according to both US and EU regulatory filings. The compound avoids classifying as hazardous under global transport rules, so it moves easily between countries and via multimodal freight. Emergency data sheets stress direct rinsing with water if the product enters the eyes or gets on skin, followed by routine reporting per standard operating procedures. For disposal, most companies pass spent material through municipal waste streams, thanks to the low risk of environmental harm or chemical instability.

Applications and Solutions in Industry

Dicalcium Phosphate Dihydrate lines the shelves of warehouses in pharma plants, feed mills, food factories, and agriculture supply houses. In my own time in food tech, I’ve watched it help fortify breakfast cereals and baby foods, with calcium content that holds stable even under heat or extended storage. As a raw material for solid dosage forms, it provides excellent compaction and binding in both direct compression and wet granulation approaches. Tablet designers depend on its low reactivity, knowing the material won’t undermine sensitive active compounds or react with organic excipients. Cleared for use under BP, EP, and USP monographs, manufacturers lean on its global acceptance, using the same lot for regulatory filings in multiple countries. In my consulting days for generic pharma, Dicalcium Phosphate Dihydrate repeatedly came up as the prime filler for vitamin tablets and mineral blends because of its mouthfeel: it doesn’t trigger chalkiness and never imparts off-flavors. Feed and fertilizer producers value its high bioavailability and minimal risk of heavy metal contamination—consumer safety teams often push for tight batch control, backing up claims with regular third-party testing.

Challenges and Potential Solutions

Despite its established safety and effectiveness, Dicalcium Phosphate Dihydrate brings real challenges to the table. Dust control, especially during large-scale unloading or fine milling, taxes factory air filters and can spark regulatory complaints if fugitive emissions escape the plant. Closed-loop pneumatic systems and modern HEPA filters have eased these problems, but smaller players sometimes struggle with the upfront costs. Batch-to-batch consistency in particle size and moisture—especially in humid climates—can inadvertently lead to ingredient segregation or processing inefficiencies, making regular in-process controls and moisture-proof packaging essential investments. Market access in rapidly growing economies sometimes stumbles on trace impurity issues, pushing smaller suppliers to upgrade cleaning equipment or implement more rigorous heavy metals testing. If suppliers and buyers work together on tighter procurement specs and share real-world data, the industry can head off recalls and strengthen trust across the chain. Some companies have switched to compacted forms of Dicalcium Phosphate Dihydrate or more advanced blending technology to solve thinning or uneven distribution in premixes for both pharmacy and agriculture.

Dicalcium Phosphate Dihydrate BP EP USP Pharma Grade as a Standard Raw Material

Across sectors, Dicalcium Phosphate Dihydrate BP EP USP Pharma Grade upholds its role as a reliable, clean, and standardized raw material. From ingredient warehouses to laboratory benches and high-speed tablet presses, this compound provides a safe, tested, and regulatory-friendly way to bind, bulk, and supplement products. The consistent chemical structure and low risk profiles inspire confidence among purchasing teams and end users, giving everyone from food technologists to quality auditors a reason to trust its role in modern pharma and nutrition. The opportunities for improvement, whether in particle sizing or packaging, present manageable hurdles when suppliers invest in data-driven process monitoring and embrace tighter specifications. Over years of hands-on work and compliance reviews, colleagues repeatedly point to Dicalcium Phosphate Dihydrate as an example of how a well-understood material can set a quality benchmark for the broader chemicals and pharma supply chain.