Material Safety Data Sheet: Metoprolol Tartrate

1. Identification

Product Name: Metoprolol Tartrate
Synonyms: Lopressor, Metoprolol Hydrogen Tartrate
CAS Number: 56392-17-7
Recommended Use: Pharmaceutical ingredient, beta blocker for cardiovascular conditions
Manufacturer: Pfizer Pharmaceuticals, Novartis, Teva Pharmaceuticals, and other global suppliers
Emergency Telephone: Poison control helpline: 1-800-222-1222 (in the United States); refer to local guidelines elsewhere
Contact Information: Provided on specific commercial packaging; refer to supplier's details

2. Hazard Identification

Classification: Not classified as hazardous under GHS for general handling in pharmaceutical environments
Risk Phrases: May cause drowsiness, fatigue, bradycardia, hypotension on significant exposure
Target Organs: Heart, circulatory system, liver with prolonged high dosages
Signal Word: Caution
Symptoms of Exposure: Nausea, dizziness, slower heart rate, respiratory distress at high levels
Routes of Exposure: Inhalation, skin and eye contact, ingestion
Label Precautions: Use gloves, eye protection, and avoid inhaling powders

3. Composition / Information on Ingredients

Chemical Name: Metoprolol Tartrate
Percent Content: 98-100% active ingredient depending on supplier
Molecular Formula: C15H25NO3·C4H6O6
Molecular Weight: 684.81 g/mol
Impurities and Stabilizers: May contain trace water, residual solvents under ICH Q3A guidelines
Other Ingredients: For bulk powder, no excipients; in finished tablets, refer to separate formulation data

4. First Aid Measures

General Guidance: Move from exposure area, check vital signs, and seek medical assistance
Inhalation: Remove to fresh air and monitor breathing, give oxygen if needed, contact doctor
Skin Contact: Wash thoroughly with soap and water, report allergic reaction or irritation
Eye Contact: Rinse cautiously with water for 15 minutes, remove contact lenses, seek eye specialist consultation
Ingestion: Rinse mouth, observe for bradycardia, do not induce vomiting, call physician or poison control
Advice for Medical Personnel: Observe for hypotension, monitor ECG, symptomatic treatment as needed for overdose

5. Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, foam, dry chemical, or carbon dioxide for small fires
Special Hazards: Carbon monoxide, carbon dioxide, nitrogen oxides may form during fire
Firefighter Protection: Wear self-contained breathing apparatus, full protective gear
Thermal Decomposition Products: Unidentified toxic fumes may evolve on rapid heating
Explosion Data: Not sensitive to mechanical impact or static discharge, low risk of explosivity

6. Accidental Release Measures

Personal Precautions: Wear gloves, lab coat, eye protection, avoid dust formation
Spill Cleanup: Ventilate area, sweep up with minimal dust, collect in labeled containers for disposal
Environmental Precautions: Prevent release into drains, watercourses, or soil
Disposal Method: Place waste in sealed chemical containers and follow local hazardous waste disposal regulations

7. Handling and Storage

Handling: Use in well-ventilated area, avoid formation of aerosols, wear personal protective equipment
Storage Conditions: Store in a cool, dry, and well-ventilated location, preferably at 20°C to 25°C
Packing Materials: Keep in tightly closed, original packaging; moisture-resistant containers
Incompatibilities: Strong oxidizers, acids, bases
Special Instructions: Label clearly, use proper shelving, restrict access to trained personnel

8. Exposure Controls and Personal Protection

Exposure Limits: No established OSHA, ACGIH, or NIOSH exposure limits for Metoprolol Tartrate
Engineering Controls: Use process enclosures, local exhaust, or other engineering controls to keep airborne levels low
Personal Protective Equipment: Protective gloves, laboratory coat, safety goggles
Respiratory Protection: NIOSH-approved dust respirator if dust is generated
Other Protection: Wash hands before eating or touching face, avoid clothing contamination, use eye wash station

9. Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
pH: 4.5–6.5 in 1% aqueous solution
Melting Point: 120°C - 138°C
Solubility: Freely soluble in water, ethanol; insoluble in chloroform and ether
Flash Point: Not applicable for solid powder
Partition Coefficient (logP): Approx -0.02
Vapor Pressure: Negligible at room temperature

10. Stability and Reactivity

Chemical Stability: Stable under standard temperature and pressure
Conditions To Avoid: Moisture, extreme heat, exposure to light, open containers
Materials To Avoid: Strong oxidizing agents, strong acids and bases
Decomposition Products: Carbon oxides and nitrogen oxides
Polymerization: Not known to occur

11. Toxicological Information

Acute Toxicity: LD50 (oral, rat): approx. 1150 mg/kg
Chronic Effects: May include effects on blood pressure, pulse, liver with prolonged high dosing
Carcinogenicity: Not listed as a carcinogen by NTP, IARC, OSHA
Reproductive Effects: Evidence of adverse reproductive outcomes only at high doses in animal studies
Symptoms from Exposure: Nausea, dizziness, bradycardia, respiratory symptoms, tremors in extreme overdose
Medical Conditions Aggravated: Asthma, existing cardiac rhythm disorders, liver impairment

12. Ecological Information

Ecotoxicity: Data limited; beta blockers may impact aquatic organisms in high concentrations
Persistence and Degradability: Not easily biodegradable, may persist in soil and water
Bioaccumulation: Low potential for bioaccumulation
Mobility in Soil: Moderate due to water solubility
Other Adverse Effects: Large releases can disrupt aquatic ecosystems near pharmaceutical plants

13. Disposal Considerations

Waste Disposal: Dispose of through licensed chemical waste facility
Incineration: High temperature incineration recommended to limit environmental contamination
Special Instructions: Do not discharge into sewer or surface water
Container Disposal: Decontaminate and manage containers as hazardous waste as appropriate
Unused Material: Return to manufacturer or approved hazardous waste handler

14. Transport Information

UN Number: Not regulated as a hazardous material for shipping
UN Proper Shipping Name: Not applicable
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Avoid waterway release, use secure packaging
Special Precautions: Store in tightly closed containers to prevent spillage during transport

15. Regulatory Information

US Federal Regulations: Not controlled under TSCA; pharmaceutical ingredient regulations apply via FDA
European Union Regulations: Complies with REACH chemical safety assessment under medicinal products
Labeling Requirements: Wear eye and skin protection, wash hands after handling
International Inventory Status: Listed on appropriate inventories as an active pharmaceutical ingredient
Other Regulations: Use restricted to professionals in dosing, distribution, and disposal