Wusu, Tacheng Prefecture, Xinjiang, China admin@sinochem-nanjing.com 3389378665@qq.com
Follow us:



Material Safety Data Sheet: Zolmitriptan

Identification

Product Name: Zolmitriptan
Chemical Formula: C16H21N3O2
Molecular Weight: 287.36 g/mol
Synonyms: Zomig, 4-((3-(2-Dimethylaminoethyl)-1H-indol-5-yl)methyl)-1,3-oxazolidin-2-one
CAS Number: 139264-17-8
Use: Pharmaceutical active for treatment of migraine headaches
Manufacturer Information: Available upon request from commercial suppliers or regulatory databases
Recommended Restrictions: For clinical and research applications, non-industrial use

Hazard Identification

Hazard Class: Not classified as hazardous under GHS criteria for pharmaceutical applications
Health Hazards: May cause skin and eye irritation, possible respiratory discomfort after dust inhalation, central nervous system effects if significant exposure
Emergency Overview: Solid, white to off-white powder. Avoid contact with eyes, skin, or inhale dust.
Signal Word: Caution
Potential Acute Symptoms: Headache, dizziness, nausea, possible allergic reactions
Potential Chronic Symptoms: Prolonged exposure may worsen migraine or CNS effects in sensitive individuals
Labelling: May require special prescription and restricted handling labels

Composition / Information on Ingredients

Ingredient: Zolmitriptan
Concentration: 98-100% (pure active)
Impurities: Trace related substances (<0.5%) as by-products of synthesis
Physical Form: Powder

First Aid Measures

Inhalation: Move person to fresh air, monitor breathing. Seek medical attention if symptoms develop.
Skin Contact: Remove contaminated clothing. Wash affected area with soap and water.
Eye Contact: Flush eyes with plenty of water for at least fifteen minutes. Get medical advice if irritation persists.
Ingestion: Rinse mouth, do not induce vomiting. Contact poison control and seek immediate medical care.
Symptoms: Nausea, headache, drowsiness, allergic symptoms possible on overexposure.

Fire-Fighting Measures

Flammability: Not considered highly flammable
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Hazardous Combustion Products: May emit oxides of nitrogen, carbon monoxide, carbon dioxide
Protective Equipment: Firefighters should use self-contained breathing apparatus and full protective clothing
Advice for Firefighters: Avoid inhaling fumes, control runoff from firefighting

Accidental Release Measures

Personal Precautions: Wear protective gloves, eye protection, lab coat, dust mask or respirator for large spills
Environmental Precautions: Prevent entry into wastewater and drains, contain any spilled powder
Cleanup Procedures: Sweep up and transfer to a sealed container, avoid generating dust, ventilate area
Decontamination: Wash surfaces with detergent and water after spill removal

Handling and Storage

Precautions for Safe Handling: Handle only inside controlled laboratory or pharmacy area. Follow good industrial hygiene practices. Avoid supplying to unauthorized personnel.
Conditions for Safe Storage: Store in tightly closed container at 20-25°C, keep away from moisture, light, and incompatible materials
Special Storage Requirements: Secure site with access records, store away from acids, oxidizers; prevent range temperature swings
Storage Class: Pharmaceuticals

Exposure Controls and Personal Protection

Exposure Limits: Not established for zolmitriptan, keep exposure to a minimum based on pharmaceutical safety guidance
Engineering Controls: Handle inside chemical fume hood or with local exhaust ventilation
Personal Protective Equipment: Lab gloves, protective clothing, safety goggles recommended
Hygiene Measures: Wash hands thoroughly after handling, do not eat or drink near active drug materials

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Solubility: Freely soluble in methanol, DMSO; sparingly soluble in water
Melting Point: 151-153°C
Boiling Point: Data not available; decomposes at elevated temperature
Density: Not available
Flash Point: Not flammable under standard test conditions
pH (solution): 5.5-6.5 (as hydrochloride salt)
Partition Coefficient (log Pow): 1.3-1.9 estimated
Vapor Pressure: Negligible
Stability: Stable under normal conditions when stored dry and protected from light

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Reactive Hazards: May be sensitive to strong acids and oxidizing agents
Decomposition: Heating may produce carbon monoxide, carbon dioxide, nitrogen oxides
Hazardous Polymerization: Will not occur
Conditions to Avoid: Exposure to moisture, intense light, elevated temperature
Incompatible Materials: Strong oxidizers, some acids

Toxicological Information

Acute Effects: Headache, nausea, dizziness, dry mouth, weakness. Clinical use shows adverse events above normal dose can lead to chest discomfort or cardiovascular changes.
Chronic Effects: No carcinogenicity reported. Repeated overexposure may affect central nervous and cardiovascular systems.
LD50 (Oral, rat): Above 2000 mg/kg (data extrapolated from animal studies)
Inhalation Toxicity: Not expected at normal handling, inhalation of dust may cause irritation
Allergy Potential: Hypersensitivity reactions or rashes have occurred in susceptible individuals
Target Organs: Central nervous system, cardiovascular system
Developmental/Reproductive Toxicity: Teratogenicity not observed in animal models at therapeutic dose; not recommended in pregnancy without physician direction

Ecological Information

Aquatic Toxicity: Low expected toxicity on aquatic life based on low solubility and biodegradation, but avoid uncontrolled discharge
Bioaccumulation: No significant potential expected due to rapid metabolism
Soil Mobility: No significant migration anticipated, most pharmaceutical waste sequesters in soil or is metabolized
Persistence and Degradability: Expected to degrade under typical sewage treatment
Environmental Impact: Avoid large-scale release; environmental risk is minimal in clinical quantities

Disposal Considerations

Waste Treatment Methods: Dispose as hazardous pharmaceutical waste according to local, state, and federal regulations
Incineration: Approved method for destruction, especially for bulk quantities
Contaminated Packaging: Cleaned container may follow standard recycling; otherwise, treat as hazardous waste
Avoid: Release into natural waterways, landfill without treatment, or mixing with general garbage
Disposal Guidance: Institutional and healthcare settings must follow controlled substance destruction protocols

Transport Information

UN Number: Not classified as a hazardous material for transport under UN criteria
Transport Hazard Class: Not regulated as dangerous goods
Packing Group: Not required
Marine Pollutant: No
Special Precautions for Transport: Seal securely, transport in a robust and labelled container, follow pharma-specific carriage rules
Transport by Air/Rail/Road: Can be shipped under standard pharmaceutical guidelines

Regulatory Information

US TSCA: Not listed, use regulated by FDA for pharmaceutical manufacturing
European Union: Subject to EMA (European Medicines Agency) guidelines, restricted to medical and research applications
WHMIS (Canada): Exempt – regulated as a drug
Inventory Status: Not registered for use outside of authorized medical channels
Labeling Requirements: Prescription only, R&D handled by licensed personnel, poison control contact listed
Other Regulation: OSHA Hazard Communication Standard does not classify zolmitriptan as hazardous but clinical use governed by drug law