Product Name: Sodium Ferric Gluconate Complex
Synonyms: Ferric Sodium Gluconate Complex, Ferrlecit
Chemical Formula: C66H121FeNaO65
CAS Number: 34089-81-1
Intended Use: Parenteral iron replacement therapy, pharmaceutical ingredient
Manufacturer Information: Individual manufacturer and distributor details are found on product packaging; always consult the supplier for specific emergency contact numbers.
Emergency Contact: Local poison control and regional emergency numbers provide best direct response for on-site exposures or spills.
GHS Classification: Not classified as hazardous according to GHS criteria, but improper handling poses risks to health.
Potential Health Effects: May cause irritation to eyes, skin, or mucous membranes on direct exposure; inhalation of dust may lead to respiratory discomfort; ingestion in large doses causes gastrointestinal symptoms such as nausea, vomiting, and diarrhea; occupational exposure requires attention to allergic reactions and chronic ingestion risks.
Label Elements: No universal pictogram required; use caution phrases such as Keep out of reach of children or Avoid contact.
Other Hazards: Iron overload from accidental or large exposure places children at high risk for acute toxicity.
Chemical Name: Sodium Ferric Gluconate Complex
Common Name: Sodium Ferric Gluconate
Concentration: Active ingredient typically over 95% purity in pharmaceutical grade; trace elements may include sodium chloride and water for injection.
CAS No.: 34089-81-1
Eyes: Flush eyes gently with large amounts of water for at least 15 minutes, keeping eyelids lifted. Seek medical attention for persistent sensitivity or pain.
Skin: Wash skin with soap and water; if redness or irritation appears, contact a health care provider. Remove contaminated clothing and wash before reuse.
Inhalation: Move person to fresh air. Support breathing; consult a physician if symptoms like coughing or shortness of breath do not clear quickly.
Ingestion: Rinse mouth with water; drink water to dilute, but do not induce vomiting unless instructed by medical professionals. For accidental overdose, treat as a potential medical emergency and contact poison control urgently.
Suitable Extinguishing Agents: Water spray, dry chemical, carbon dioxide, and foam work for most secondary fires.
Specific Hazards: Substance itself does not burn, but dried residues may contribute minor combustion products under strong heat; keep away from excessive heat as complex decomposition releases iron oxides and sodium compounds.
Protective Equipment: Firefighters should use self-contained breathing apparatus and protective gear to avoid inhalation of gases and smoke from burning packaging or surroundings.
Special Precautions: Prevent run-off water from entering drains, as elemental iron compounds can affect water chemistry in significant quantities.
Personal Precautions: Wear gloves, eye protection, and lab coat or apron; avoid breathing dust, especially during cleanup of powdered or dried material.
Environmental Precautions: Prevent spills from reaching surface waters and sewer systems; contain bulk liquid using inert absorbents such as sand or clay.
Cleanup Methods: Absorb spillage with inert materials and transfer for disposal according to local environmental rules; wash area well with water following solid removal.
Handling: Use with adequate ventilation; minimize dust generation during weighing and preparation; always close containers tightly after removing material.
Storage: Keep containers stored upright at room temperature, protected from excessive light and moisture. Maintain storage area free from incompatible substances such as strong acids or bases.
Occupational Exposure Limits: Not established specifically for sodium ferric gluconate; for iron salts OSHA PEL (Permissible Exposure Limit): 1 mg/m3 (as iron fume).
Appropriate Engineering Controls: Work under fume hood or use local exhaust ventilation in case of powder handling.
Personal Protective Equipment: Safety goggles, disposable gloves, lab coat; NIOSH-approved mask for large dust concentrations; no open-toe shoes in work area; eyewash and emergency shower should be nearby.
Appearance: Brown to orange-red amorphous powder or dark brown liquid concentrate.
Odor: Slight, characteristic odor sometimes present; not persistent.
Solubility: Completely soluble in water, limited in non-polar solvents.
pH: 7.7 - 9.7 (at typical injectable concentration).
Melting Point/Freezing Point: Not defined due to complex nature.
Boiling Point: Aqueous solutions boil at water’s standard boiling point; solid decomposes before boiling.
Other Data: Stable under normal storage; reacts with strong oxidizing or reducing agents.
Chemical Stability: Product remains stable in sealed containers under recommended conditions.
Incompatible Materials: Avoid contact with strong acids which decompose the iron complex, producing free iron ions and gluconic acid.
Hazardous Decomposition Products: Thermal decomposition or exposure to high temperatures releases iron oxides, sodium compounds, and potentially toxic organic vapors.
Hazardous Polymerization: No known hazard from polymerization under standard working conditions.
Acute Toxicity: Large oral doses cause gastrointestinal distress, liver injury, and risk of systemic iron overload, particularly in children.
Chronic Toxicity: Prolonged high exposure leads to hemochromatosis or organ iron deposition.
Sensitization: Rare skin or respiratory sensitization in individuals with hypersensitivity to iron compounds.
Carcinogenicity/Mutagenicity: No components comprised in this complex classified as carcinogenic or mutagenic by IARC, NTP, OSHA, or ACGIH.
Other Effects: Therapeutic use in patients with known iron metabolism disorders raises the danger for adverse effects.
Aquatic Toxicity: High amounts in water affect aquatic organisms through iron deposition; not expected to bioaccumulate significantly but disrupts natural water iron levels.
Persistence and Degradability: Iron and gluconate quickly dissociate and degrade under normal water/soil conditions; sodium salts stay soluble and mobile.
Mobility in Soil: The complex is water-soluble, may leach through soil profiles if disposed without treatment.
Waste Treatment Methods: Dispose unused, excess, or contaminated product in accordance with local, regional, or national environmental regulations.
Precautions: Do not discharge untreated product into watercourses, surface waters, or soil; consult hazardous waste contractor as required by local healthcare or pharmaceutical protocol.
Container Handling: Triple-rinse containers before recycling or disposal; follow established law for sharps or injectable vials.
UN Number: Product not assigned a UN number for domestic or international transport.
Shipping Name: Not regulated as a dangerous good unless formulated with other hazardous components.
Hazard Class: Not classified under DOT, TDG, IMDG, or IATA regulations.
Packaging Recommendations: Use sturdy, leak-proof containers with tamper sealing to prevent spills during shipment; secure with absorbent packing material if shipped in bulk.
US Regulations: Not listed as a hazardous substance under SARA Title III, CERCLA, or RCRA; included in inventory for pharmaceutical substances by FDA.
EU Regulations: No classification required under REACH for human medicinal products; consult ECHA database for updates on handling or environmental safety notices.
Other Regional Standards: Compliance with local national pharmaceutical and chemical safety laws enforced through specific agency listing; some states require worker right-to-know documentation.
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