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Material Safety Data Sheet (MSDS) – Lansoprazole Chloride

1. Identification

Product Name: Lansoprazole Chloride
Chemical Formula: C16H14F3N3O2S·HCl
CAS Number: 138530-94-6
Synonyms: Lansoprazole hydrochloride
Use: Proton pump inhibitor, reduces stomach acid production for gastrointestinal disorders
Manufacturer Name: Refer to product packaging or Safety Department contact
Emergency Contact: National Poison Control Center or local emergency services

2. Hazard Identification

Classification: Harmful if swallowed, causes serious eye irritation, may cause respiratory irritation
Hazard Symbols: Irritant (Xi), Harmful (Xn)
Signal Word: Warning
Route of Exposure: Inhalation, ingestion, skin and eye contact
Potential Effects: Nausea, headache, allergic reactions, irritation to skin, eyes, and respiratory system
Precautionary Statements: Avoid dust. Keep away from food and beverages. Use personal protection. Store in a closed container.

3. Composition / Information on Ingredients

Chemical Name: Lansoprazole Chloride
Concentration: 98-100%
Additives or Impurities: No significant impurities at relevant concentrations for classification.

4. First Aid Measures

General Advice: Move away from exposure. Seek immediate medical attention if unwell.
Inhalation: Remove to fresh air. Provide artificial respiration if necessary. Seek medical help.
Skin Contact: Rinse skin with water for at least 15 minutes. Remove contaminated clothing.
Eye Contact: Rinse eyes with plenty of water for at least 15 minutes, lifting eyelids occasionally.
Ingestion: Rinse mouth. Do not induce vomiting without medical advice. Drink water if conscious. Get medical attention.

5. Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam.
Hazardous Combustion Products: Hydrogen chloride, nitrogen oxides, sulfur oxides, carbon oxides, fluoride compounds
Protective Equipment: Firefighters wear full protective gear and self-contained breathing apparatus.
Special Hazards: Thermal decomposition releases toxic gases.

6. Accidental Release Measures

Personal Precautions: Wear gloves, protective clothing, safety goggles, dust mask or respirator.
Environmental Precautions: Avoid discharge into drains, surface water, soil.
Methods for Containment and Cleaning: Sweep up without creating dust. Place in suitable, labeled waste container. Ventilate area and wash site after material pickup.

7. Handling and Storage

Handling: Work in well-ventilated areas. Minimize dust generation. Wash hands thoroughly after handling.
Storage Conditions: Store in tightly closed, original container at room temperature. Keep out of direct sunlight, away from incompatible substances (acids, oxidizers, bases).
Incompatibilities: Protect against moisture, excessive heat. Separate from strong oxidizers and strong acids.

8. Exposure Controls / Personal Protection

Exposure Limits: No established occupational exposure limits. Use local exhaust ventilation.
Engineering Controls: Enclosed handling, fume hood, dust control equipment recommended.
Personal Protective Equipment: Chemical-resistant gloves, lab coat or protective suit, safety goggles, appropriate respiratory protection if dust or aerosols form.
Hygiene Measures: Do not eat, drink, or smoke during use. Wash exposed skin thoroughly after handling.

9. Physical and Chemical Properties

Appearance: White to light yellow powder or crystals
Odor: No characteristic odor
Molecular Weight: 407.82 g/mol (Lansoprazole base)
Melting Point: Approximately 167-170°C
Solubility: Low solubility in water, more soluble in organic solvents
pH: 5-8 (aqueous solution)
Boiling Point: Not applicable
Vapor Pressure: Negligible
Flash Point: Not available

10. Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions.
Conditions to Avoid: Moisture, strong light, extreme temperatures, strong oxidizers, acids, and bases
Hazardous Decomposition Products: Formation of toxic gases, including hydrogen chloride, nitrogen oxides, sulfur oxides, and fluorides under fire or decomposition
Polymerization: Not known to occur

11. Toxicological Information

Acute Toxicity: Data limited, may be harmful if swallowed, inhaled, or absorbed through skin
Skin Corrosion/Irritation: May cause irritation on contact
Eye Damage/Irritation: Irritating to eyes
Respiratory Effects: Dust may irritate respiratory tract
Allergic Reactions: Rare hypersensitivity possible
Chronic Toxicity: No chronic toxicity in humans at therapeutic doses; long-term or high dose animal studies show risk of gastric tumors
Other Information: No evidence of carcinogenicity found in animals at relevant exposure levels.

12. Ecological Information

Environmental Fate: Not readily biodegradable
Toxicity: Low acute aquatic toxicity anticipated; limited data on aquatic species
Persistence and Degradability: Persists in environment, slow to degrade
Bioaccumulation Potential: Potential for bioaccumulation in aquatic organisms remains uncertain
Mobility in Soil: Limited mobility, binds to soil particles

13. Disposal Considerations

Waste Treatment Methods: Dispose of in accordance with local, regional, national, and international regulations.
Incineration: High-temperature incineration preferred for pharmaceutical chemicals
Contaminated Packaging: Dispose as chemical waste; clean before recycling or reuse if possible.
Do Not: Release into drains, watercourses, or environment.

14. Transport Information

UN Number: Not classified as hazardous for transport
DOT/ADR/RID/IMDG/IATA: Not regulated as dangerous goods
Packing Group: Not assigned
Transport Labels: None required
Special Precautions: Use precautions typical for fine chemical powders.

15. Regulatory Information

Regulatory Status: Not listed on US TSCA, not subject to specific labeling under EU CLP regulations
OSHA: Not specifically regulated
REACH: Substance exempt as an active pharmaceutical ingredient used under prescription
Other Country Listings: Varies; check local regulations
SARA / CERCLA / RCRA: Not considered hazardous waste by these US standards
WHMIS (Canada): Not controlled
California Proposition 65: Not listed as a known carcinogen or reproductive toxicant