MSDS for Almotriptan Malate

1. Identification

Product Name: Almotriptan Malate
Chemical Name: 1-{3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide malate (1:1)
Synonyms: Almotriptan, Almogran
CAS Number: 154323-57-6
Recommended Use: Pharmaceutical active ingredient for migraine treatment
Manufacturer / Supplier: Pharmaceutical manufacturer, details per acquisition source
Emergency Contact: Refer to regional poison control or medical toxicology service

2. Hazard Identification

GHS Classification: Acute toxicity (Oral Category 4), Eye irritation (Category 2A), Specific target organ toxicity (Category 3)
Label Elements: Warning symbol for health hazard, exclamation mark
Hazard Statements: May cause drowsiness or dizziness, may cause mild irritation to eyes and mucous membranes, harmful if swallowed at concentrated levels
Precautionary Statements: Avoid inhalation, keep away from food and beverages, use only in ventilated areas
Potential Health Effects: Exposure may trigger migraine-like responses, moderate risk for hypersensitivity, prolonged contact can irritate skin or eyes

3. Composition / Information on Ingredients

Chemical Formula: C17H25N3O2S·C4H6O5
Main Ingredient: Almotriptan Malate — 99%
Impurities: <1% (not considered significant under current thresholds)
Physical State: Solid, powder or crystalline

4. First Aid Measures

General: Remove from exposure. Seek medical attention if symptoms develop or persist.
Inhalation: Move to fresh air. Seek medical help if respiratory symptoms appear.
Skin Contact: Wash with plenty of soap and water. Remove contaminated clothing.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present. Seek medical help for irritation.
Ingestion: Rinse mouth. Do not induce vomiting unless directed by medical personnel. Seek immediate medical attention for large quantities.

5. Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide. Select agent for surrounding materials.
Specific Hazards: Combustion may release toxic fumes including nitrogen oxides, sulfur oxides, carbon oxides.
Protective Equipment: Firefighters should wear self-contained breathing apparatus and protective clothing.
Special Procedures: Use water spray to cool fire-exposed containers.
Explosion Data: No known unusual fire or explosion hazards.

6. Accidental Release Measures

Personal Precautions: Wear appropriate personal protective equipment including gloves, safety goggles, and dust mask.
Environmental Precautions: Prevent further leakage or spillage. Avoid release to the environment. Local regulations may require reporting.
Cleanup Methods: Sweep up and place in suitable, labeled container for disposal. Avoid creating dust. Ventilate area.
Disposal: Follow safe disposal protocols for pharmaceutical actives.

7. Handling and Storage

Handling: Avoid breathing dust and direct contact with skin, eyes, and clothing. Use in a well-ventilated space and employ containment to minimize exposure.
Storage: Keep container tightly closed in a cool, dry, well-ventilated location. Store away from incompatible materials such as strong acids or oxidizers. Maintain security and inventory control for pharmaceuticals.
Hygiene Practices: Wash hands thoroughly after handling. Do not eat, drink, or smoke in work area.

8. Exposure Controls and Personal Protection

Engineering Controls: Provide exhaust ventilation or other engineering controls to minimize airborne concentrations.
Eye/Face Protection: Use chemical safety goggles or face shield.
Skin Protection: Wear chemical-resistant gloves and lab coat or apron.
Respiratory Protection: Use approved respirators if airborne concentrations exceed safe levels.
Occupational Exposure Limits: Not established for this specific compound; other controls guided by good laboratory practice.

9. Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or faint medicinal
Odor Threshold: Not characterized
pH: 3.5–5.5 (1% aqueous solution)
Melting Point: Around 176°C (malate salt form)
Boiling Point: Decomposes before boiling
Solubility: Soluble in water, slightly soluble in methanol, practically insoluble in chloroform
Vapor Pressure: Not relevant (non-volatile solid)
Density: Data not available
Partition Coefficient (log Pow): Estimated 1.5 (base form)
Flash Point: Not applicable
Evaporation Rate: Not applicable

10. Stability and Reactivity

Chemical Stability: Stable under normal recommended handling and storage conditions.
Reactive Hazards: No significant reactivity hazard under standard use.
Incompatible Materials: Strong oxidizing agents, strong acids.
Hazardous Decomposition Products: May generate nitrogen oxides, sulfur oxides, carbon oxides when exposed to fire.
Polymerization: No known hazard for polymerization.

11. Toxicological Information

Likely Routes of Exposure: Inhalation, ingestion, dermal, ocular.
Acute Effects: Large doses may produce dizziness, drowsiness, headache, nausea or allergic reaction.
Chronic Effects: Repeated occupational exposure may contribute to mild skin or eye irritation. No evidence for carcinogenicity or mutagenicity in standard studies to date.
Sensitization: Rare hypersensitivity reported in some individuals.
Toxicity Data: Oral LD50 in rodents is over 500 mg/kg.
Additional Information: No confirmed human target organ toxicity outside intended pharmacological effect.

12. Ecological Information

Ecotoxicity: Not expected to be highly toxic to aquatic organisms at environmental concentrations, but pharmaceutical products can persist and disrupt aquatic environments.
Persistence and Degradability: Not readily biodegradable; may persist in soils and water.
Bioaccumulation: Low potential for bioaccumulation based on structure and water solubility.
Mobility in Soil: May migrate with water due to solubility.
Other Adverse Effects: Avoid uncontrolled release to the environment.

13. Disposal Considerations

Waste Generation: Dispose of excess and waste material in accordance with local, state, and federal regulations.
Methods of Disposal: Incineration is typically effective for pharmaceuticals. Do not flush to sewer systems.
Contaminated Packaging: Rinse thoroughly before recycling or disposal, or dispose as pharmaceutical waste.
Precautions: Prevent release to environment by secure containment prior to disposal.

14. Transport Information

UN Number: Not classified as hazardous for transport.
UN Proper Shipping Name: Almotriptan Malate, not a regulated item for ground or air freight under typical pharmaceutical quantities.
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Special Precautions: Avoid transport with incompatible chemicals or foodstuffs. Ensure packaging is secure and correctly labeled.

15. Regulatory Information

Labeling: Prescription or research pharmaceutical, subject to national medicines regulation.
OSHA Status: Not classified as hazardous under US OSHA Hazard Communication Standard 29 CFR 1910.1200.
TSCA: Listed only for research and development as a pharmaceutical active.
SARA Title III: Not listed as hazardous.
WHMIS Classification (Canada): Non-controlled product.
REACH (EU): Not specifically listed; handled under medicinal product directives.
Other Local Regulation: Users should refer to country and province specific regulations relating to the handling, use, and disposal of pharmaceutical substances.