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Cefotaxime Sodium: Detailed Product Description and Analysis

What is Cefotaxime Sodium?

Cefotaxime Sodium stands out as a third-generation cephalosporin antibiotic, widely valued in hospital and clinical settings, especially for treating severe or complicated bacterial infections. Produced through an advanced fermentation and chemical processing route, Cefotaxime Sodium finds itself in vials, ampoules, and bags throughout the world’s pharmacies and supply rooms. The molecular formula is C16H16N5NaO7S2, with a molar mass of about 477.45 g/mol. At a glance, Cefotaxime Sodium usually appears as a nearly white to slightly yellow, crystalline powder that dissolves quickly in water, bringing convenience for rapid compounding and immediate use.

Physical and Chemical Properties

Cefotaxime Sodium’s structure contains a beta-lactam ring fused with a dihydrothiazine ring, which creates its broad bacterial killing spectrum. Stability depends strongly on moisture and temperature: this compound tends to degrade if left exposed in humid conditions, which reduces its effectiveness. The powder holds a specific gravity close to 1.6 g/cm3 and demonstrates high solubility in water, forming clear to slightly opalescent solutions. Compared to its base compound, the sodium salt enhances compatibility with intravenous fluids, supporting higher dosing without clogging IV sets. Chemical purity should meet pharmaceutical standards, with low levels of related substances, moisture, and heavy metals. Typical specification calls for a purity above 98%. Raw material quality impacts yield, sterility, and safety, emphasizing the importance of quality sourcing and careful handling to prevent harmful byproducts like endotoxins.

HS Code, Form, and Handling

International trade categorizes Cefotaxime Sodium using the HS Code 29419090, which covers “other antibiotics.” This code not only helps customs officials classify the antibiotic but also connects to import rules, taxes, and shipping requirements. Importers and wholesalers must track these codes to ensure compliance and price their products effectively. Logistically, suppliers deliver Cefotaxime Sodium as solid crystalline powder, sometimes processed into flakes, pearls, or granulated solid to make bulk handling safer and reduce inhalation risks. Crystal size varies — fine micronized powder often goes into pharmaceutical blending, while larger flakes or granules help balance flowability for industrial production. No established liquid or pearl form typically ships to end users unless specifically compounded, but labs and manufacturing settings tailor the material as needed.

Molecular Structure and Safety Concerns

Chemically, the molecule’s stability hinges on the integrity of its beta-lactam ring. Cephalosporin structures can be fragile: breakage leads to loss of antimicrobial activity, so storage at 2–8°C protects material up to its expiration date. This sensitivity extends to manufacturing, transport, and pharmacy preparation. Since Cefotaxime Sodium can cause allergic reactions in sensitive individuals, its hazardous profile includes skin and eye irritation, anaphylactic risks, and nephrotoxicity at high doses or prolonged exposure. Direct inhalation or ingestion harms workers or bystanders—complying with strict PPE protocols (gloves, goggles, masks) protects employee safety. Environmental impact ranks as moderate; while the compound breaks down under typical conditions, improper disposal may affect aquatic life through groundwater runoff. Responsible waste management in line with local chemical disposal rules reduces potential long-term harm both to people and ecosystems.

Density, Solubility, and Solution Preparation

Density of Cefotaxime Sodium powder falls near 1.6 g/cm3, which supports easy measurement in both grams and liters for large-scale pharmacy or industrial applications. The powder dissolves swiftly in sterile water or saline, yielding clear solutions suitable for injection. Solubility remains a key property: it permits flexibility for compounding exact dosages, especially critical for pediatric or renal-dosed medicines. Preparing the solution requires careful aseptic technique, since any contamination endangers patient health. As the chemical remains stable only under acidic to neutral pH, pharmacists often buffer the solution slightly to maintain potency. Stability in solution affects how hospitals schedule medication rounds: once reconstituted, most vials should be used within a few hours unless stored cold and protected from light.

Raw Materials and Manufacturing Considerations

Producing Cefotaxime Sodium requires several high-quality raw materials, including cephalosporin C, specialized reagents for acylation, and pharmaceutical-grade sodium carbonate. Each stage brings the risk of impurity introduction, requiring ongoing monitoring to assure safety and batch reliability. Many manufacturers operate under strict GMP guidelines, employing closed systems and analytical QC checkpoints. Controlling contamination tells a lot about a plant’s reliability: poor raw materials or slipshod cleaning can lead to residual solvents, heavy metals, or microbiological contamination — all of which must fall below specified limits in the final product. Sterile filtration, lyophilization, and high-barrier packaging all extend shelf life, illustrating the resourcefulness of the supply chain to get a potent, safe drug from synthesis to bedside.

Discussion of Safety, Hazards, and Best Practices

Safety matters at every stage: accidental exposure during weighing or blending often causes skin rashes or respiratory allergies. In severe incidents, those already allergic to penicillins face life-threatening reactions, demanding epinephrine and swift emergency care. Proper training, ventilation, and inventory management cut down on accidental exposure. On a larger scale, antimicrobial resistance challenges stem from improper disposal or substandard dosing. Pharma companies now work with governments to track production lots, extend expiry monitoring, and educate healthcare workers. These combined efforts help keep Cefotaxime Sodium effective longer — a monumental task, given rising global bacterial resistance. Every stakeholder plays a part: pharmacists label and seal vials, hospitals monitor store temperatures, logistics staff track temperature during transport, and manufacturers audit suppliers for reliability and compliance.

Potential Solutions and Improvements

While Cefotaxime Sodium’s benefits remain clear, challenges call out for solutions. Industry-wide, better tracking of sourcing limits the risk of adulterated or contaminated raw materials entering the production line. Improvements in packaging technology — from tamper-evident vials to desiccant-lined bottles — lengthen shelf life and cut loss from storage mistakes. At the laboratory bench, analytical advances in HPLC and mass spectrometry allow detection of microscopic impurities, giving real-time feedback to chemists and plant supervisors. On the ground level, training every staff member how to handle, store, and dispose of Cefotaxime Sodium safely cuts accidental waste and protects local waterways and communities from chemical spills. Refined procedures, ongoing quality education, and robust regulatory oversight all together keep the pipeline for this vital antibiotic flowing smoothly, ready to fight infection wherever the need arises.