Product Name: Stibogluconate de sodium
Synonyms: Sodium stibogluconate, Pentostam
Recommended Uses: Antileishmanial pharmaceutical
Manufacturer: Sanofi, GlaxoSmithKline
Emergency Contact: Regional Poison Control, Supplier, Local emergency
CAS Number: 16037-91-5
UN Number: This material does not usually ship as a hazardous material, but consult local authority.
Formula: C12H16Na5O16Sb
Relevant Identified Uses: Only for use under medical supervision
Restrictions: Not for household, food, agricultural or environmental use.
Classification: Acute toxicity (oral, dermal), eye irritation, acute aquatic hazard
Labeling Elements: Irritant symbol required, avoid contact
Route of Exposure: Inhalation, ingestion, skin, eyes
Health Hazards: Can cause nausea, vomiting, abdominal pain, headache, ECG changes (prolonged QT), pancreatitis, hepatotoxicity, rash
Environment Hazards: Harmful to aquatic life, limited biodegradation, do not discharge to drains
Pictograms: GHS07 (Exclamation Mark), GHS09 (Environmental Hazard)
Signal Word: Warning
Precautionary Statements: Prevent environmental release, avoid direct handling
Hazard Statements: May be harmful if swallowed; causes skin and eye irritation
Chemical Name: Sodium stibogluconate
Common Name: Stibogluconate de sodium
INCI Name: Sodium stibogluconate
CAS Number: 16037-91-5
Purity: Typically above 99% in medical-grade formulation
Impurities: Trace antimony salts, moisture, sodium chloride (USP grade)
Molecular Weight: 687.95 g/mol
Formulation: Purified, sterile solution for medical injection or powder for reconstitution
Other Notable Ingredients: Pharmaceutical vehicle (water for injection), stabilizers as per manufacturer
Inhalation: Remove to fresh air; provide oxygen if breathing is difficult; seek medical assistance if symptoms persist
Ingestion: Seek immediate medical attention, rinse mouth, do not induce vomiting unless directed by medical professional
Skin Contact: Wash area thoroughly with soap and water, remove contaminated clothing, seek medical advice if redness or adverse reaction develops
Eye Contact: Rinse cautiously with water for at least 15 minutes, remove contact lenses if present and easy, get medical help promptly
Notes for Physicians: Supportive care is crucial. Monitor electrolytes, liver, and cardiac function.
Symptoms and Effects: Nausea, vomiting, muscle pain, skin rash, cardiac arrhythmias
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Media: Do not use high-pressure water jet
Specific Hazards: Product not flammable, but containers exposed to fire may rupture; stibogluconate decomposes into antimony oxides under intense heat
Protective Equipment: Wear self-contained breathing apparatus, full turnout gear
Special Procedures: Move containers from fire area if safe, contain firefighting run-off
Hazardous Combustion Products: Antimony oxides, sodium oxides, carbon monoxide and dioxide
Personal Precautions: Avoid direct contact, ensure adequate ventilation, use appropriate personal protective equipment (PPE)
Environmental Precautions: Prevent entry into water, drains, or soil; notify authorities in event of major spill
Containment: Absorb liquid component with inert material; handle broken glassware with forceps
Cleanup: Sweep or vacuum spilled material, moisten to minimize dust if powder, collect in approved waste container
Decontamination: Wash surfaces and equipment thoroughly with water; collect washings for disposal
Disposal: Store in labeled hazardous waste container for proper disposal
Handling: Only trained personnel should handle; use in fume hood or well-ventilated area; avoid splashes and aerosol formation
Storage: Store tightly closed in original container, cool, dry place, protected from light
Temperature Requirements: Store at 2–8°C for injectable; prevent freezing and overheating
Segregation: Keep away from strong oxidizers, acids, bases, incompatible chemicals
Hygiene Measures: Wash hands, remove contaminated clothing before breaks, avoid eating or drinking in work area
Packing Materials: Glass vials for pharmaceutical use; secondary containers made of inert, chemical-resistant materials
Engineering Controls: fume hood; local exhaust to reduce airborne exposure
Exposure Limits: ACGIH TLV for antimony compounds: 0.5 mg/m³ (as Sb), none established for compound itself
Respiratory Protection: NIOSH-approved respirator if risk of dust or aerosol exists
Eye Protection: Chemical safety goggles
Hand Protection: Chemical resistant gloves (nitrile, latex, or neoprene)
Clothing: Lab coat, apron, closed shoes
Environmental Controls: Do not allow uncontrolled environmental release
Work Practice Controls: Isolate from incompatible substances, label work area
Appearance: White or off-white, amorphous or crystalline powder; dissolved as clear colorless to faint yellow solution for injection
Odor: Odorless
pH (1% solution): 6.5 – 8.0
Melting Point: Decomposes before melting
Boiling Point: Not applicable (decomposes)
Solubility: Freely soluble in water, practically insoluble in alcohols and organic solvents
Density: 2.1 – 2.3 g/cm³ (as solid)
Vapor Pressure: Not applicable
Partition Coefficient: No measurable n-octanol/water partitioning
Stability in Solution: Stable in aqueous solution when protected from heat and light
Flammability: Non-flammable
Chemical Stability: Stable under recommended storage and handling conditions
Decomposition: Decomposes on strong heating to antimony oxides and sodium compounds
Incompatibility: Strong acids, oxidizers, alkalis, reducing agents
Polymerization: Will not polymerize
Hazardous Reactions: Formation of toxic vapors possible if combusted
Conditions to Avoid: Excessive heat, light, contamination
Acute Toxicity: LD50 (oral, rat): Not fully determined; considered moderate toxicity; significant at clinical doses
Chronic Toxicity: Prolonged exposure may cause cumulative antimony toxicity, affecting heart, liver, pancreas and bone marrow
Routes of Exposure: Inhalation, ingestion, skin absorption, injection
Symptoms: Abdominal pain, vomiting, diarrhea, sweating, ECG changes, pancreatitis, hepatitis, rash, hypotension
Carcinogenicity: No clear evidence in humans; antimony compounds classed as possible carcinogen by IARC
Teratogenicity: Not sufficient data for effect in pregnancy; avoid exposure unless benefit outweighs risk
Mutagenicity: No definitive data
Sensitization: Allergic reactions and skin sensitization are possible
Medical Conditions Aggravated: Liver disorder, kidney disease, existing cardiac problems
Ecotoxicity: Toxic to aquatic organisms; low threshold for water contamination
Mobility: High water solubility means potential for movement in water
Persistence: Antimony species resist breakdown in environment; potential for accumulation
Bioaccumulation: Some risk, especially in aquatic plants and organisms
Aquatic Toxicity: May inhibit growth or kill algae, daphnia, aquatic invertebrates
Soil Effects: Can disrupt microbial activity
Other Information: Avoid uncontrolled discharge; follow local spill protocol
Wastes: Must be disposed as hazardous waste, incineration in licensed facility preferred; do not flush to drain
Container Disposal: Triple rinse, deface labels, dispose as hazardous waste per regulations
Regulatory Status: Classified as special waste depending on jurisdiction; do not mix with other chemicals
Precautions: Avoid contact during disposal, use PPE
Incineration: Suitable with proper off-gas scrubbing to contain antimony
Consult Local Authority: Follow local/national requirements for antimonial waste
UN Number: None assigned for medical diluted solution; may be regulated as UN3077 (Environmentally hazardous substance, solid, n.o.s.) if bulk
Hazard Class: Depends on concentration and packaging; medical vials not regulated but bulk chemical may be
Packaging Group: III if applicable
Labels: Environment hazard if regulated
Shipping Name: Consult product insert, shipping manifests
Special Precautions: Keep upright, protect from temperature extremes
EmS: For marine transport, F-A, S-F
Regulatory Lists: Listed on: EU REACH, United States TSCA, Canada DSL/NDSL
Workplace Regulations: OSHA (US), COSHH (UK), WHMIS (Canada) for handling of toxic metals
Pharmaceutical Regulation: Listed under national medicines agencies (EMA, FDA, Health Canada) as prescription drug
Risk Phrases: R22: Harmful if swallowed; R36/38: Irritating to eyes and skin
Safety Phrases: S22: Do not breathe dust; S36/37: Wear protective clothing and gloves
Restrictions: Only to be used under medical supervision
Environmental Legislation: Strict control for disposal, reporting requirement for significant spills
Other Labelling: Product code, batch number, expiration, manufacturer information on all pharmaceutical packaging
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