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Cisapride Material Safety Data Sheet (MSDS)

Identification

Product Name: Cisapride
Chemical Formula: C23H29ClFN3O4
CAS Number: 81098-60-4
Synonyms: Prepulsid
Recommended Use: Prokinetic agent for gastrointestinal disorders
Manufacturer: Refer to specific supplier
Emergency Contact: Refer to local regulations and supplier information

Hazard Identification

Classification: Not classified as highly hazardous, still can cause cardiac arrhythmias and gastrointestinal effects
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Hazard Statements: Harmful if swallowed; may cause serious cardiac arrhythmias especially in at-risk populations; irritates mucous membranes; risk increases with drug interactions
Signal Word: Warning
Precautionary Statements: Avoid contact with skin and eyes; avoid inhaling dust; wash hands thoroughly after handling; keep away from incompatible substances
Other Hazards: May cause environmental harm if released to water systems

Composition / Information on Ingredients

Cisapride Monohydrate: 98-100%
Impurities: Maximum 2% (including related substances from synthesis)
Additives: None specified; product usually handled in pure or compounded pharmaceutical form
Additional Note: No common stabilizers or preservatives in pure bulk powder

First Aid Measures

Inhalation: Move person to fresh air; seek medical attention if symptoms such as breathing difficulty, dizziness, or chest pain develop
Skin Contact: Wash area thoroughly with soap and water; remove contaminated clothing and seek medical care if persistent irritation develops
Eye Contact: Flush eyes with plenty of water for at least fifteen minutes; seek medical care if irritation persists
Ingestion: Rinse mouth with water; do not induce vomiting; seek immediate medical attention, especially if arrhythmia or other symptoms develop
Camre Consideration: Provide safety data to medical personnel if available, especially regarding potential for arrhythmias

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Media: Avoid high-pressure water streams that may spread material
Specific Hazards: May produce toxic fumes including HCl, nitrogen oxides, fluorine compounds, and carbon monoxide during combustion
Protective Equipment: Firefighters should wear self-contained breathing apparatus and protective gear
Firefighting Advice: Move containers from fire area if safe; cool affected containers with water

Accidental Release Measures

Personal Precautions: Wear suitable PPE including gloves, goggles, laboratory coat, and mask when handling powder
Environmental Precautions: Prevent entry into waterways, sewers, and soil
Cleanup Methods: Sweep or vacuum up material, avoiding dust generation; use damp cloth for residue
Disposal: Collect in suitable, sealed containers for regulations-compliant disposal
Decontamination: Wash spill area thoroughly after cleanup

Handling and Storage

Handling: Use in well-ventilated area; minimize generation of dust; avoid eating, drinking or smoking while handling; practice good hygiene
Storage: Keep containers tightly closed; store in cool, dry, well-ventilated location away from incompatible substances like strong oxidizing agents
Storage Temperature: Room temperature recommended; avoid excessive heat, moisture and direct sunlight
Incompatibilities: Do not store near strong acids, bases, or oxidizers

Exposure Controls and Personal Protection

Workplace Exposure Limits: No specific OSHA or ACGIH exposure limit established; use with appropriate controls to avoid exposure
Engineering Controls: Use local exhaust ventilation or fume hood
PPE (Personal Protective Equipment): Chemical-resistant gloves (nitrile or latex), safety glasses or goggles, lab coat, mask (N95 or better for dust)
Hygiene Measures: Wash hands thoroughly after handling product; remove and wash contaminated clothing before reuse

Physical and Chemical Properties

Appearance: White or off-white crystalline powder
Odor: Odorless
pH: Not available
Melting Point: 108-110°C
Boiling Point: Decomposes before boiling
Solubility: Slightly soluble in water, more in methanol and ethanol
Density: Approximately 1.37 g/cm³
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log P): Approximately 3.6
Stability: Stable under normal storage and handling conditions

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Reactivity: Not known to undergo dangerous reactions under normal conditions
Hazardous Reactions: Can react with strong oxidizers; rapid decomposition can occur with excessive heat
Conditions to Avoid: Direct sunlight, excessive moisture, temperatures above recommended storage
Incompatible Materials: Strong acids, bases, and oxidizers
Decomposition Products: May produce hydrogen chloride, fluorine compounds, carbon oxides, nitrogen oxides

Toxicological Information

Acute Toxicity: Harmful if swallowed; oral LD50 for rats estimated around 1-2 g/kg
Chronic Toxicity: Known to cause cardiac arrhythmias and gastrointestinal disturbances in humans with prolonged exposure
Routes of Exposure: Ingestion, skin and eye contact, inhalation
Symptoms: Nausea, vomiting, diarrhea, abdominal pain, palpitations, risk of prolonged QT and torsades de pointes
Carcinogenicity: No data indicating human carcinogenicity, not listed by IARC or NTP
Sensitization: Not reported, but skin irritation possible
Mutagenicity: No standard mutagenic effects reported in literature

Ecological Information

Aquatic Toxicity: Potentially harmful to aquatic life due to pharmaceutical activity and persistency
Persistence and Degradability: Tends to be persistent, not readily biodegradable
Bioaccumulation Potential: Data limited, modest concern due to log P value
Soil Mobility: Likely limited but some mobility possible especially as fine particulates
Other Effects: Pharmaceutical compounds can disrupt aquatic environments if wastewater treatment is ineffective

Disposal Considerations

Waste Disposal Methods: Incinerate under controlled conditions according to local, state, and federal regulations; avoid landfill
Packing Disposal: Dispose of contaminated packaging as hazardous waste; do not reuse containers
Environmental Precautions: Do not dispose in sewage system, groundwater, or uncontained land environments
Regulatory Guidance: Consult with certified waste disposal contractor to ensure regulatory compliance

Transport Information

UN Number: None assigned
Proper Shipping Name: Cisapride, not classified as dangerous for transport per major regulations
Transport Hazard Class: Not regulated
Packing Group: None specified
Marine Pollutant: Not designated but avoid aquatic release
Special Precautions: Ship in secure containers; avoid extreme conditions during transit; keep away from foodstuffs and incompatible substances

Regulatory Information

US Regulation: Prescription pharmaceutical, withdrawn from US market due to cardiac risk; not listed on US TSCA; not considered controlled substance
EU Regulation: Prescription status, subject to various restrictions depending on country
WHMIS/Class: Not classified in Canada
GHS Classification: Category 4 (acute toxicity), health hazard warning
Other Regulations: Monitoring and handling must follow stringent pharmaceutical, occupational, and environmental controls