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Amikacin Sulfate: Comprehensive Material and Chemical Description

What is Amikacin Sulfate?

Amikacin Sulfate stands out as a well-known aminoglycoside antibiotic salt, used primarily to fight off serious bacterial infections. The chemical structure reveals a complex assembly of amino sugars attached by glycosidic bonds to a central aminocyclitol ring. The formula C22H43N5O13S, with a molar mass of approximately 585.66 g/mol, reflects its significant molecular size and complexity. The compound showcases a crystalline solid appearance when isolated in its pure form, often produced as a white, odorless powder or as small crystalline flakes. Amikacin Sulfate boasts a CAS Number 39831-55-5, and it sits under HS Code 29419090 for international customs and trade.

Physical Properties and Specifications

The physical features offer clear identification: Amikacin Sulfate appears as a fine white to off-white hygroscopic powder, sometimes encountered in crystalline flakes, reflecting its high solubility in water and moderate density, which typically falls within about 0.7–0.9 g/cm3 as a solid. Its high degree of solubility, upwards of 50 mg/mL at room temperature, makes it straightforward to prepare aqueous solutions with concentrations tailored for pharmaceutical formulations or laboratory investigation. It does not form distinctive “pearls” or solidified spheres, and remains stable in its solid state when kept in a sealed container away from moisture and light. In liquid form, such as within injectable vials, the substance fully disperses, leaving no particulate evidence, a sign of its chemical compatibility with water as a solvent.

Chemical Structure and Key Properties

Amikacin Sulfate’s structure includes several amino groups and an O-linked 4-amino-2-hydroxybutyryl side chain, which gives it broad activity against gram-negative bacteria and resilience against many beta-lactamases and aminoglycoside-inactivating enzymes. This structural adaptability enables clinicians to choose this raw material where resistance or allergies limit the use of other antibiotics. From a chemist’s perspective, amikacin’s property profile makes it appealing for synthetic modification and pharmaceutical development. The solid form resists mild temperature changes, yet the compound remains sensitive to strong acids or bases, and its sulfate group enhances stability under physiological conditions.

Handling, Hazards, and Safety Considerations

Practical handling of Amikacin Sulfate involves specific steps to minimize exposure and risks. Like all aminoglycosides, this raw material poses a potential for nephrotoxicity and ototoxicity when mishandled. Direct contact with the powder, or its inhalation, may produce skin and eye irritation and irritation of the respiratory tract. Once under solution, its handling typically requires gloves, goggles, and lab coats, with local exhaust ventilation recommended. Spills, while rare, must be cleaned with absorbent material, collected in a sealed chemical waste container, and disposed of according to hazardous chemical protocols. The substance is not highly flammable, but storage ought to occur in a dry, cool place well away from oxidizing agents.

Applications and Importance in Healthcare

Hospitals and laboratories rely on amikacin sulfate for injectable formulations targeting stubborn or hospital-acquired infections. The antibiotic is indispensable for treating multi-resistant bacterial strains, particularly in intensive care environments where other agents fail. A recent World Health Organization survey highlighted the rise in demand for such aminoglycosides, with Amikacin Sulfate ranked as an essential medicine due to its activity spectrum and tolerability profile in severe infections. Many medical professionals stress the importance of its raw material purity, since even minor impurities may increase adverse reactions or reduce potency, complicating treatment regimens.

Quality Assurance and Raw Material Sourcing

Pharmaceutical-grade Amikacin Sulfate requires strict monitoring for contaminants and compliance with specifications established by pharmacopeial standards such as USP, Ph. Eur., and JP. The material should test free from heavy metals, residual solvents, and microbial contamination. Reliable suppliers invest heavily in quality control, documenting every batch and providing certificates of analysis to trace origin and quality parameters. As global pharmaceutical supply chains face increased scrutiny following several contamination incidents involving other drug raw materials, sourcing Amikacin Sulfate from trustworthy producers has become even more important for drug manufacturers and hospital compounding departments.

Molecular Behavior and Solution Characteristics

Amikacin Sulfate dissolves rapidly in water, creating clear, colorless solutions suitable for intravenous or intramuscular use. Once reconstituted, the solution displays pH values from about 3.5 to 5.5, buffered by the sulfate counter-ion. Stability studies show that the solution keeps its activity profile for a defined period under refrigeration, though some degradation may occur with prolonged room temperature exposure. This behavior stems directly from its molecular structure, where multiple polar groups attract water and facilitate dissolution. Researchers studying degradation patterns or attempting to modify the active moiety pay attention to solution stability, as it influences shelf life and the transition to ready-to-use injectable formats.

Challenges and Pathways Toward Safer Handling

Unlike some commonly used pharmaceuticals, Amikacin Sulfate requires a watchful eye in both distribution and application. Manufacturing sites operate with strict dust abatement strategies to avoid respiratory exposure risks, while pharmacists emphasize secure packaging when transferring the chemical into hospital settings. Some facilities have invested in single-use, prefilled syringe formats, reducing direct handling of the raw material. Stakeholders urge ongoing research into better toxicity prediction methods, robust environmental protocols, and adaptive safety guidelines, since occupational exposure studies in the chemical manufacturing sector have revealed rare but real risks from long-term low-level contact. These studies reinforce the need for regular employee training, clear signage, and up-to-date emergency procedures wherever Amikacin Sulfate raw material moves or gets stored.

Final Thoughts on Amikacin Sulfate Material and Practice

As someone who has witnessed shifts in pharmaceutical material sourcing and safety standards, I see the attention paid to Amikacin Sulfate’s properties, handling, and supply chain as a reflection of broader trends in medicine and materials science. Quality, documentation, and risk management define success in modern pharmaceutical operations. Technicians, chemists, and clinicians must work with detailed understanding of what this material is, how its density or solubility affects formulation choices, and how safe practices reduce hazards while maintaining the ethical standards patients and regulators expect. Strong material knowledge, combined with responsible sourcing and real-world safety measures, bridge the gap between the laboratory and the hospital, coping with both predictable and unexpected challenges in healthcare delivery.