Aluminium Glycinate BP EP USP Pharma Grade: Physical Characteristics and Detailed Product Guide

What is Aluminium Glycinate BP EP USP Pharma Grade?

Aluminium Glycinate BP EP USP Pharma Grade serves an important function in the pharmaceutical sector, drawing on its stable chemical structure and reliable safety record. The compound stands out as a synthetic coordination complex formed by combining aluminium ions with glycine molecules, yielding a white to off-white powder or crystalline solid. Its full chemical formula appears as C4H8AlN2O4, which provides insight into its elemental makeup and predictable reactions under laboratory conditions. This material is sometimes offered in powder, crystalline, or even flake form, depending on the intended application. Across pharma manufacturing, the touchpoint for Aluminium Glycinate often links to its role as a pharmaceutical raw material and excipient, offering controlled aluminium release and a compatible profile with active pharmaceutical ingredients.

Products and Raw Materials

Many pharmaceutical developers look to Aluminium Glycinate for its consistency and ease of handling. Derived from readily available aluminium salts and glycine, the synthesis process usually guarantees high purity levels to meet BP, EP, and USP standards. The finished product rarely carries visible impurities, with strict controls over heavy metals, chloride, sulfate, and arsenic. Consistent raw materials underpin dependable final outcomes; a deviation can introduce risks tied to pharmaceutical integrity or patient safety. The HS Code for Aluminium Glycinate usually falls under 2922.49, covering amino acid derivatives. Purity generally exceeds 98%, which is routinely verified by validated analytical methods, ensuring conformity to regulatory requirements and patient expectations.

Properties and Structure

Stability characterizes Aluminium Glycinate, both in storage and once blended with other pharmaceutical compounds. Its molecular structure, featuring one aluminium atom chelated by two glycine molecules, offers both solubility and low reactivity, lowering the risk of unwanted side reactions during drug compounding. The molecular weight comes in at approximately 194.09 g/mol, making calculations straightforward for chemical engineers and lab technicians alike. Its solid or powder form resists caking under normal conditions, helping maintain consistent dosing throughout processing, packaging, and end use. The density typically ranges from 1.4 to 1.6 g/cm³, a manageable value for storage and transport requirements as seen in both small laboratories and large manufacturing sites. Formulations with varying solvent content may offer liquid, crystalline, or even 'pearl' forms, depending on adjustment of water or carrier solvents during processing.

Specifications and Analytical Profile

Across pharmaceutical markets, Aluminium Glycinate must meet strict specifications set out by pharmacopeial monographs. These standards include detailed limits on water content (often below 2.0%), precise identification by IR or UV-Vis spectroscopy, and strictly controlled limits on impurities like heavy metals (<10 ppm) and microbiological contamination. In laboratories, colourimetric assays, titrations, and chromatography methods help verify batch-to-batch consistency, and product supplied for oral or topical drug formulations must routinely match these rigorous expectations. Granule or powder flow properties, particle size distribution, and solubility (generally soluble in water, sparingly soluble in alcohol) factor into logistic decisions as well as process scale-up.

Density, Appearance, and Material Safety

Manufacturers encounter Aluminium Glycinate as an odorless, slightly hygroscopic, solid or crystalline powder. Handling protocols support workplace safety, controlling dust, minimizing inhalation risks, and preventing contact with eyes or skin. The density—consistent through pharma-grade batches—affects volumetric dosing and storage. In cases where the compound is used as a solution, concentration and pH are carefully monitored to prevent precipitation or loss of aluminium bioavailability. The compound does not present major fire risks but, as a fine particulate, can become an irritant if not handled under standard operating conditions. Chemical compatibility studies remain vital for co-formulation, since some excipients or active ingredients may react even with low-reactivity substances.

Hazardous, Harmful, and Safe Handling Properties

Aluminium Glycinate rarely qualifies as hazardous under standard regulations, but users must treat all chemical raw materials with respect. Prolonged inhalation of dust may irritate respiratory passages; protective masks and gloves minimize the potential for exposure during weighing or blending operations. The oral LD50 in laboratory animals indicates low toxicity, supporting its use in regulated pharmaceuticals; yet direct ingestion by workers should never occur. Eye contact leads to temporary irritation, so eyewash facilities find a place near production lines. Emergency data sheets (SDS) provide complete details on first aid, accidental release, and fire fighting measures. Regulatory compliance through REACH and GHS labeling ensures workers and logistics teams recognize the safe limits and environmental impacts of accidental release or improper disposal.

Pharmaceutical Uses, Applications, and Potential Solutions for Safe Implementation

Aluminium Glycinate serves not just as a scientific curiosity but as a practical excipient in antacid and anti-ulcer drugs, leveraging both its gentle neutralizing action and its ability to provide aluminium in a bioavailable form. In my own work supporting pharmaceutical scaling, ensuring the right grade and specification guarded against costly delays or recalls when manufacturing teams needed quality certificates. Where worker safety and product quality intersect, solutions center on transparent data sharing—clear safety data sheets, properly calibrated venting systems, and regular health surveillance for employees exposed to long-term dust generation. Waste minimization and recycling efforts, such as encapsulating recovered dust for reuse, also shrink environmental impact.

Molecular and Chemical Profile for Regulatory Transparency

The chemical profile of Aluminium Glycinate, including its simple structure and stable properties, supports classification under pharmacopoeial monographs. Regulatory authorities receive documentation detailing elemental composition, property values, molecular weight, structure diagrams, and toxicity graphs as part of the product dossier. This accountability fosters trust and transparency for downstream buyers, clinicians, and—ultimately—patients. The structure, combining carbons, nitrogens, hydrogens, aluminium, and oxygen, allows robust elemental analysis. Information dissemination about reactivity, shelf life, and best storage conditions (dry, cool, sealed) increases safe and predictable use throughout the global supply chain. Demand for reliable pharmaceutical ingredients grows as drug substances and complex dosage forms populate the treatment landscape, and Aluminium Glycinate enters these networks as a time-tested, well-documented, and science-backed building block for both innovative and legacy drug products.