Dihydroxyaluminium Aminoacetate BP EP USP Pharma Grade: An In-Depth Look

What is Dihydroxyaluminium Aminoacetate?

Dihydroxyaluminium Aminoacetate comes up often in conversations about pharmaceutical excipients. For people in the industry, this compound matters because it crops up in a bunch of antacid formulations and various pharmaceutical preparations. The formal molecular formula is C2H6AlNO4. Structurally, the molecule features an aluminium core bonded to two hydroxyl groups and an aminoacetate group. The way the structure holds together links the metal with nitrogen and oxygen, which gives the compound the kind of stability and reactivity that pharmaceutical applications require.

Physical Appearance and Forms

Walking through a manufacturing plant or lab, you’ll run into Dihydroxyaluminium Aminoacetate in different forms. In its pure state, the compound typically shows up as a white, odorless, crystalline powder or solid flakes. Some suppliers offer it in the form of small pearls or granules, but the powder remains the most common. The density ranges from about 0.8 to 1.2 g/cm³, which means it sits at a spot that lets it disperse well into liquid vehicles without clumping or caking. It’s not hygroscopic, so it does not grab water from the air easily, keeping handling straightforward and shelf life solid under normal storage.

Chemical Properties and Specifications

People who work in pharma keep a close eye on purity standards and reactivity. Dihydroxyaluminium Aminoacetate used in compliance with BP, EP, and USP standards runs with an assay of at least 98%, as significant impurities can shift how the compound interacts with other materials. It dissolves in water to form a slightly alkaline solution, usually clocking in at a pH around 7.5 to 8.5. The molecular weight sits near 120.06 g/mol. Chemical stability means it won’t break down under normal manufacturing or storage conditions. HS Code falls under 2922.49, marking it as an organic chemical that local and international authorities regulate closely.

Applications and Raw Material Properties

Pharmaceutical manufacturers depend on Dihydroxyaluminium Aminoacetate as a raw material because it gets the job done when they need an effective antacid. Its aluminium content reacts with gastric acid to reduce symptoms of heartburn and indigestion. Beyond antacids, it pops up in some vaccine adjuvants and controlled-release drug formulations. Here, the physical properties, like a non-volatile, non-flammable solid and a moderate solubility profile, really matter because they keep drug products safe, stable, and predictable. These characteristics come straight from the compound’s structure and the choice to keep impurities low, letting the end user rely on the compound’s documented effects.

Handling, Hazards, and Safety Considerations

Even though Dihydroxyaluminium Aminoacetate earns a spot as generally safe in pharmaceutical use, there’s no skipping proper handling. As a fine powder, it can create dust, and nobody wants to inhale that in a manufacturing setup. Safety data sheets mark the compound as basically non-flammable and low in acute toxicity, but repeated or high exposure could upset those with sensitive respiratory systems. Dermal contact, accidental ingestion, or eye exposure out of the lab context call for immediate first aid and possibly medical attention. The right training and gear, including gloves, dust masks, and sealed storage, keep the workplace protected and the raw material uncontaminated.

Molecular Structure, Crystal Habit, and Solubility

The structure exists as a coordination complex, with each aluminium atom surrounded by oxygen and nitrogen donors from the aminoacetate, forming neutral or slightly basic crystalline solids. The crystal habit generally runs orthorhombic, but can shift depending on how the raw material crystallizes out of solution. Water solubility isn’t total but is sufficient for the material to dissolve at pharmacopeial concentrations. This solubility lets formulators blend the compound into suspension, gels, and some semi-solids, which extends its use far beyond simple tablet blends. The aluminum moiety helps to buffer the solution, giving stability that’s valued in multi-active ingredient preparations.

Storage, Packing, and Stability Concerns

Any facility that stores large quantities of Dihydroxyaluminium Aminoacetate aims to keep it in dry, cool surroundings, often inside double-lined bags, fiber drums, or HDPE containers. High humidity or temperature swings don’t immediately ruin the product but can speed up degradation in the presence of incompatible chemicals. Most regulatory files recommend storage below 25°C, away from acids and moisture sources. Handling and storing the material like this preserves not just the physical appearance but the integrity of the molecular structure, which keeps reactivity in check and allows it to pass routine QC testing.

Regulatory and Documentation Details

Dihydroxyaluminium Aminoacetate processed to BP, EP, and USP requirements comes with a full batch record and certificate of analysis. These documents outline aspects like assay, loss on drying, heavy metals, and microbial limits. The HS Code classification (2922.49) helps streamline logistics and customs paperwork worldwide. On the safety side, each shipment includes a Material Safety Data Sheet, giving regulatory authorities what they need for hazard communication and environmental protection.

Environmental Impact and Waste Handling

Even as a low-toxicity, low-hazard chemical, Dihydroxyaluminium Aminoacetate can’t be dumped indiscriminately. Disposal practices matter. Most environmental agencies treat it as non-hazardous but call for containment—no pouring powder or solution straight into a drain or landfill. Solid waste should be collected in sealed containers and either incinerated at authorized plants or sent for secure landfill under company protocols that comply with city and national environmental laws.