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Product Name: Zonisamide
Chemical Name: 1,2-benzisoxazole-3-methanesulfonamide
Synonyms: Zonegran
Molecular Formula: C8H8N2O3S
Molecular Weight: 212.23 g/mol
CAS Number: 68291-97-4
Recommended Use: Antiepileptic medication
Manufacturer: Refer to authorized pharmaceutical producers
Contact for Emergency: Refer to institutional emergency number or local poison control
Classification: Not classified under GHS for most workplace exposures; for bulk material, risk of dust inhalation and skin/eye irritation
Physical Hazards: Fine powder may form combustible dust concentrations in air
Health Hazards: May cause skin, eye, and respiratory tract irritation; may cause allergic skin reactions; ingestion can result in nausea, dizziness, or more severe effects in overdose
Signal Word: Caution
Pictograms: Exclamation mark (acute toxicity, irritant)
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Target Organs: Central nervous system, skin, respiratory system
Precautionary Statements: Avoid breathing dust; wash hands thoroughly after handling; avoid contact with eyes, skin, and clothing; use only in well-ventilated areas
Chemical Name: Zonisamide
Concentration: 99% or higher for bulk API; pharmaceutical formulations contain smaller proportions mixed with excipients
Impurities and Stabilizing Additives: Not considered significant at therapeutic concentrations; refer to Certificate of Analysis for specifics
Other Components: Commercial formulations may include cellulose, starch, magnesium stearate, dyes, gelatin, and other excipients depending on the manufacturer
CAS Numbers for excipients: Refer to product label or manufacturer for specifics
Inhalation: Move to fresh air promptly; seek medical attention if cough, shortness of breath, or other symptoms develop
Skin Contact: Rinse affected area with soap and water; remove contaminated clothing; get medical help if irritation persists
Eye Contact: Rinse eyes cautiously with water for several minutes; remove contact lenses if present and easy to do; continue rinsing; get medical help if irritation occurs
Ingestion: Rinse mouth; do not induce vomiting, unless directed by medical professional; seek medical advice or poison center assistance
Most Important Symptoms and Effects: Nausea, dizziness, possible allergic reaction, respiratory irritation; exposure to large quantities may lead to seizures, blood disorders, or metabolic acidosis, particularly in clinical overdose
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide as appropriate for surroundings
Specific Hazards Arising from Chemical: Formation of fumes containing carbon oxides, nitrogen oxides, sulfur oxides upon combustion; potential for dust explosion
Protective Equipment for Firefighters: Use self-contained breathing apparatus and full protective clothing
Firefighting Instructions: Contain runoff; keep upwind to avoid hazardous fumes
Personal Precautions: Wear appropriate protective equipment including gloves, goggles, and respiratory protection if dust is generated
Environmental Precautions: Prevent entry into waterways, drains, or soil
Methods for Containment and Cleaning Up: Avoid generating dust; sweep or shovel into suitable, labeled containers for disposal; wipe contaminated surfaces; ventilate area; wash after handling
Spill Response Equipment: Provided spill kits should include absorbent materials, waste bags, and cleaning agents for non-residue removal
Handling: Use in a clean, well-ventilated area; avoid dust formation; avoid skin or eye contact; wash hands thoroughly after handling
Storage: Store in tightly closed containers in a cool, dry, well-ventilated space away from incompatible substances; protect from moisture and direct sunlight
Special Considerations: Keep away from heat sources, flames, or sparks; follow pharmaceutical storage guidelines, including security and record-keeping requirements for controlled substances as applicable
Incompatibilities: Strong acids, strong bases, oxidizing materials
Exposure Limits: Occupational exposure limits not established for zonisamide; handle as a pharmaceutical bulk active ingredient—follow good industrial hygiene practices
Engineering Controls: Local exhaust ventilation or process enclosure recommended to minimize dust exposure
Personal Protective Equipment: Protective gloves (nitrile or latex), safety goggles, lab coat or other protective clothing, NIOSH-approved respirator in situations where dust is excessive
Hygiene Considerations: Wash hands and exposed skin after handling; do not eat, drink, or smoke in work areas; remove contaminated clothing immediately
Environmental Controls: Prevent release to the environment as per regulations for hazardous pharmaceuticals
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not available
pH: Slightly acidic (in water suspension)
Melting Point: 163-165°C
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not available
Evaporation Rate: Not applicable
Flammability: Not flammable under normal conditions, but may form combustible dust
Vapor Pressure: Negligible at room temperature
Vapor Density: Not applicable
Solubility: Slightly soluble in water; soluble in strong acids/bases; moderately soluble in methanol, acetone, ethanol
Partition Coefficient (log Pow): 0.3–0.9
Auto-Ignition Temperature: Not determined
Decomposition Temperature: Above 163°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions
Reactivity: Not reactive under normal handling and storage
Conditions to Avoid: Excessive heat, moisture, light exposure; generation of dust
Incompatible Materials: Strong oxidizers, strong acids, strong bases
Hazardous Decomposition Products: Carbon oxides (COx), nitrogen oxides (NOx), sulfur oxides (SOx) from thermal decomposition
Hazardous Polymerization: Will not occur
Routes of Exposure: Inhalation, ingestion, skin, eyes
Acute Effects: Inhalation or ingestion may cause headache, nausea, dizziness; higher doses may induce lethargy, CNS depression, skin rashes, metabolic acidosis, blood cell changes such as agranulocytosis
Chronic Effects: Based on medical use, chronic exposure associated with kidney stones, metabolic disturbances (acidosis), skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis), mood changes
LD50 (oral, rat): >2800 mg/kg
Mutagenicity: Not found to be mutagenic in standard laboratory assays
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Reproductive Toxicity: Animal studies suggest risk to fetus at high doses; avoid use in pregnancy unless necessary
Allergenicity: Rare but serious skin reactions possible
Ecotoxicity: Data limited for zonisamide; pharmaceutical compounds may enter aquatic environments through wastewater; long-term effects unknown
Persistence and Degradability: Degradation data limited; likely persistent where pharmaceuticals accumulate
Bioaccumulation Potential: Low log Pow suggests low potential for bioaccumulation
Mobility in Soil: Likely moderate mobility due to solubility characteristics
Other Adverse Effects: Caution to prevent active pharmaceutical ingredient release to natural environment as effects on non-target species are not fully understood
Waste Treatment Methods: Dispose of material in accordance with national and local regulations for pharmaceuticals; incineration preferred for bulk waste
Product Disposal: Do not dispose of product in household garbage or via sewage system; consult waste handler experienced with pharmaceutical compounds
Contaminated Packaging: Dispose of packaging after thorough decontamination; observe official requirements
Precautions: Avoid contamination of water and soil; keep out of reach of unauthorized individuals
UN Number: Not regulated as a hazardous material under UN transport regulations (for finished product)
UN Proper Shipping Name: Not applicable
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not designated as marine pollutant
Special Precautions for User: Avoid damage to packaging, moisture ingress, or temperature extremes during transport; comply with specific packaging and security rules for pharmaceuticals
Regulatory Status: Prescription pharmaceutical; regulated under various national drug laws such as US FDA, EMA, PMDA (Japan), as an antiepileptic agent
OSHA Status: Not specifically regulated under OSHA hazardous chemicals; handle with pharmaceutical safety protocols
TSCA: Exempt as a pharmaceutical product
SARA Title III: Not listed as an extremely hazardous substance
DSL/NDSL (Canada): Not specifically listed, but allowed as finished pharmaceutical
WHMIS Classification (Canada): Not controlled as hazardous product
Other Legislation: Follow all applicable pharmaceutical safety, disposal, and environmental protection laws
