Product Name: Loperamide Hydrochloride
Chemical Formula: C29H33ClN2O2
Common Names: Loperamide, Imodium
CAS Number: 53179-11-6
Manufacturer: Information based on general industry sources
Recommended Use: Active pharmaceutical ingredient in anti-diarrheal medications
Contact Points: Pharmacy, hospital, chemical safety managers, poison control center
Emergency Phone: Refer to local poison control or emergency services
Health Hazards: May cause central nervous system effects, risk of respiratory depression if misused, irritation to eyes and skin if handled improperly, possible gastrointestinal discomfort.
Environmental Hazards: Limited evidence of aquatic toxicity, potential hazard if large quantities enter water courses.
Physical Hazards: Stable under normal temperature and pressure, dust generation may cause respiratory irritation.
Signal Word: Warning
Pictograms: Exclamation mark (irritant)
Hazard Statements: May be harmful if swallowed in excess, avoid contact with skin and eyes, may cause drowsiness.
Precautionary Statements: Store in a secure location, avoid release to environment, use personal protective gear during handling.
Chemical Name: Loperamide Hydrochloride
PURITY: 98-102% depending on grade
Impurities: Trace synthesis by-products may be present
Description: White or almost white powder
Solubility: Slightly soluble in water, freely soluble in ethanol and methanol
Inhalation: Move to fresh air, seek medical attention if symptoms persist or breathing difficulty arises, avoid giving mouth-to-mouth if safety is uncertain.
Skin Contact: Remove contaminated clothing, wash affected area with plenty of soap and water, seek medical advice if irritation develops.
Eye Contact: Rinse immediately with plenty of clean water for at least 10 minutes, hold eyelids open, seek emergency attention if pain or swelling continues.
Ingestion: Do not induce vomiting, rinse mouth, give water if person is conscious, seek immediate medical attention, show MSDS to doctor.
Note to Physician: Symptomatic and supportive treatment, attention to respiratory and cardiac functions.
Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, alcohol-resistant foam
Unsuitable Media: Do not use water jets directly onto material
Special Exposure Hazards: Dust in air could create an explosive mixture, toxic fumes possible on decomposition
Protective Equipment: Self-contained breathing apparatus, chemical protective suit, avoid inhalation of combustion products
Firefighting Procedures: Prevent run-off from entering drains, contain firewater, cool containers exposed to fire with water spray
Personal Precautions: Wear gloves, goggles, lab coat, NIOSH-approved dust mask where required, ventilate area
Environmental Precautions: Prevent from entering drains, surface water, and soil, notify authorities if large spill affects environment
Methods for Cleanup: Warm-area containment if possible, sweep up using spark-proof tools, avoid dust formation, place residue in closed, properly labeled containers for disposal
Decontamination: Wash area with water and detergent after removal of bulk material
Handling: Work in well-ventilated area, avoid creation of dust, use personal protection gear, observe no eating or drinking near material
Storage: Store in tightly closed containers, keep in cool, dry, and well-ventilated location, separate from incompatible substances, away from light and moisture, keep out of reach of children
Incompatibilities: Strong oxidizers, strong acids or bases may degrade product or cause hazardous reaction
Engineering Controls: Local exhaust or other engineering controls to keep airborne levels below recommended exposure limits
Exposure Limits: No specific occupational exposure limit established; treat as particulate not otherwise classified
Respiratory Protection: NIOSH-approved dust mask or respirator if airborne dust becomes significant
Eye Protection: Chemical safety goggles or face shield
Skin Protection: Nitrile gloves, lab coat or protective clothing
Ventilation: Use with adequate ventilation, especially for large quantities or prolonged work
Hygiene Measures: Wash hands thoroughly after handling, remove contaminated clothing, avoid touching face
Appearance: White to almost white crystalline powder
Odor: Odorless
pH: 4.0–5.0 (1% solution)
Shelf Life: Stable for years if stored properly
Melting Point: Approximately 220–230°C
Solubility: Sparingly soluble in water, soluble in ethanol, methanol, and chloroform
Relative Density: 1.31 g/cm³
Boiling Point: Not applicable (decomposes)
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Pow): Approximately 4.4
Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Heat, moisture, direct sunlight, incompatible materials
Materials to Avoid: Strong oxidizers, strong acids or bases
Hazardous Decomposition: Possible products include nitrogen oxides, hydrogen chloride, carbon monoxide, carbon dioxide
Polymerization: Not expected under normal conditions
Reactivity: Not reactive with most materials at room temperature
Acute Toxicity: Oral LD50 in rats: 185 mg/kg
Inhalation: No specific data, but dust may irritate respiratory tract
Skin Contact: Possible mild irritation
Eye Contact: May cause mild irritation or redness
Chronic Effects: At high doses or prolonged exposure, risk of central nervous system depression, possible cardiac effects including QT prolongation and arrhythmia
Carcinogenicity: No evidence of carcinogenicity in animal studies
Reproductive Effects: No established effects in therapeutic doses
Mutagenicity: No relevant evidence in standard tests
Ecotoxicity: Limited information available, chronic aquatic toxicity not ruled out
Persistence: Not readily biodegradable
Bioaccumulative Potential: May bioaccumulate significantly, log Pow indicates possible risk
Mobility in Soil: Likely moderate to low mobility due to low solubility
Additional Advice: Avoid contamination of water sources, large spills may impact aquatic organisms
Disposal Methods: Dispose via licensed chemical waste contractor, incineration recommended for larger quantities
Waste Classification: Dispose as hazardous pharmaceutical waste in accordance with local, state, and federal regulations
Contaminated Packaging: Dispose of as chemical waste, do not reuse containers, puncture and triple rinse if regulations demand
Environmental Precautions: Prevent releases to environment, ensure compliance with regional waste policies
UN Number: Not classified as dangerous good for transport
Proper Shipping Name: Not regulated
Transport Hazard Class: Not classified
Packing Group: Not assigned
Environmental Hazards: Not listed as marine pollutant
Special Precautions: Protect from rough handling, moisture, and extreme temperatures during transport
Labelling: No special hazard labeling required under GHS for finished pharmaceutical product in most jurisdictions, but raw material may require “harmful” or “irritant” labeling
Inventory Listing: Present on major chemical inventories like TSCA (US), EINECS (EU), DSL (Canada), AICS (Australia)
Controlled Substance Status: Not scheduled under international conventions; subject to some national controls related to misuse or bulk handling
Workplace Regulation: Subject to general occupational hygiene standards, employers required to provide material training and safety instructions
SARA/OSHA Compliance: Not classified under SARA Title III, not listed as carcinogenic by NTP, IARC, or OSHA
Global Harmonization: Follows guidance under GHS and relevant regional adaptations, adhere to workplace right-to-know laws
