Material Safety Data Sheet: Sodium Ferric Gluconate

Identification

Product Name: Sodium Ferric Gluconate Complex
Synonyms: Ferric Sodium Gluconate, Ferrlecit
Chemical Formula: C66H121FeNaO65
CAS Number: 34089-81-1
Use: Treatment of iron deficiency anemia, laboratory reagent
Supplier: Pharmaceutical manufacturers, chemical suppliers
Emergency Contact: Refer to your workplace safety officer or CHEMTREC for emergencies.

Hazard Identification

GHS Classification: Not classified as hazardous under GHS for normal laboratory use
Hazards: Overexposure can cause gastrointestinal discomfort, nausea, vomiting, and potential iron overload in medical overdose cases
Label Elements: Avoid inhalation or contact with eyes and skin; use appropriate personal protective equipment (PPE); prevent ingestion
Potential Effects: Chronic exposure may damage liver, cardiovascular system, or kidneys through iron accumulation
Precautionary Statements: Minimize unnecessary handling, wash after use, and avoid eating or drinking during work

Composition / Information on Ingredients

Sodium Ferric Gluconate: 100% (Chemical Formula: C66H121FeNaO65)
Impurities: None expected at reportable concentrations from reputable pharmaceutical manufacturers
Other Components: May contain water for injection (if in solution), trace stabilizers possible in formulated products
Molecular Weight: 1871 g/mol

First Aid Measures

Eye Contact: Rinse thoroughly with water for several minutes. Seek medical attention if irritation develops or persists
Skin Contact: Remove contaminated clothing, wash exposed area with soap and water. Seek help if skin reaction occurs
Inhalation: Move person to fresh air, keep warm and at rest, seek medical attention for difficulty breathing
Ingestion: Rinse mouth with water. Seek immediate medical help. Do not give anything by mouth to an unconscious person

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide depending on the surrounding fire
Special Hazards: Combustion can release toxic fumes including carbon oxides, iron oxides, sodium oxides
Protective Equipment: Firefighters wear self-contained breathing apparatus (SCBA) and protective suit
Advice for Firefighters: Remain upwind, avoid breathing smoke, cool containers with water spray to prevent pressure buildup

Accidental Release Measures

Personal Protection: Evacuate unnecessary personnel, wear gloves, goggles, lab coat or coveralls
Spill Cleanup: Sweep or scoop up solid material without generating dust. For liquid, absorb with inert material like sand or vermiculite
Environmental Precaution: Prevent product from entering drains, surface water, or soil
Cleaning: Place material in suitable, labeled container for disposal. Wash area with plenty of water

Handling and Storage

Safe Handling: Open containers with care, avoid inhaling dust, prevent contact with skin and eyes, use work in a well-ventilated or fume hood environment
Storage: Store in tightly sealed container away from moisture, direct sunlight, and incompatible substances like strong oxidizers and acids
Temperature Control: Keep between 2°C and 25°C. Avoid freezing or excessive heat if supplied as an injection
Incompatibilities: Strong acids, oxidizers, certain metals can cause decomposition or hazardous reactions

Exposure Controls and Personal Protection

Occupational Exposure Limit: No established ACGIH or OSHA threshold limits for sodium ferric gluconate
Engineering Controls: Use chemical fume hood or equivalent local exhaust ventilation
Personal Protective Equipment: Chemical safety goggles, gloves (nitrile), laboratory coat, closed footwear, and in some cases, respirator (for dust)
Hygiene: Do not eat, drink, or smoke in working area; wash hands after handling
Environmental Controls: Use spill containment to avoid environmental releases

Physical and Chemical Properties

Form: Yellow-brown amorphous solid or reddish-brown solution (for injectable)
Odor: Odorless
Solubility: Soluble in water, insoluble in organic solvents
Melting Point: Not determined (decomposes before melting)
Boiling Point: Not applicable (decomposes)
pH: Typically around 7.7 to 9.7 (in solution)
Relative Density: 1.15–1.25 g/mL (solution)
Vapor Pressure: Not applicable
Partition Coefficient (n-octanol/water): Not determined

Stability and Reactivity

Stability: Stable under recommended handling and storage conditions
Conditions to Avoid: Extreme heat, strong acids, strong oxidizing agents, materials that react with iron or sodium ions
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, iron oxides, sodium compounds
Polymerization: Not known to occur under normal conditions

Toxicological Information

Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Effects: Nausea, vomiting, abdominal pain, diarrhea (if ingested in large quantities), irritation (from dust to eyes, skin)
Chronic Effects: Hemochromatosis or organ damage from long-term iron overload in susceptible individuals
LD50 (rat, oral): Data not readily available; iron salts in general have moderate toxicity
Signs of Overexposure: Weakness, drowsiness, hypotension, metabolic acidosis may occur in severe toxicity
Carcinogenicity: Not listed as carcinogen by IARC, NTP, or OSHA

Ecological Information

Ecotoxicity: No significant data for sodium ferric gluconate, though release of iron salts in large quantities can impact aquatic life by altering water chemistry
Persistence and Degradability: Organic portion expected to be biodegradable; iron component persists in the environment
Bioaccumulation: Iron can accumulate in soil or sediment, especially near chronic sources
Mobility in Soil: High solubility in water means migration in aquatic environments is possible
Other Adverse Effects: High iron concentrations may cause algal blooms or toxicity to aquatic species

Disposal Considerations

Waste Disposal: Handle as nonhazardous chemical waste for most laboratories, follow institutional chemical waste procedures. Do not dump in drains, watercourses, or uncontrolled landfills
Container Disposal: Rinse and dispose of according to local, regional, and national regulations
Special Precautions: If in liquid form, absorb onto suitable material and place in chemical waste container

Transport Information

UN Number: Not regulated for transport
Transport Hazard Class: Not classified as hazardous for shipping by air, ground, or sea
Packing Group: Not assigned
Environmental Hazards: Not considered hazardous to environment in small quantities typical for research or pharmaceutical use
Special Precautions: Prevent damage to packaging, keep away from incompatible goods

Regulatory Information

US TSCA: Listed
EU REACH: Not specifically listed; substances may be exempt due to use as medicinal product
OSHA: Not classified as hazardous chemical
WHMIS (Canada): Not controlled product
Other Regulatory Status: Check compliance for specific regions, especially for pharmaceutical use or disposal regulations. Keep Safety Data Sheet accessible to all personnel handling the product.