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Product Name: Loperamide Hydrochloride
Synonyms: Imodium Hydrochloride
Chemical Formula: C29H34Cl2N2O2·HCl
CAS Number: 34552-83-5
Intended Use: Pharmaceutical ingredient used to manage diarrhea
Manufacturer Information: Refer to local supplier records for contact details
Emergency Contact: Follow local regulatory listings for poison control or chemical response lines
GHS Classification: Acute Toxicity (Oral, Category 4), Specific Target Organ Toxicity (Single Exposure, Category 3, Narcotic effects)
Signal Word: Warning
Hazard Statements: Harmful if swallowed, may cause drowsiness or dizziness
Symbol: Exclamation mark icon for warning
Precautionary Measures: Wash hands thoroughly after handling, avoid eating or drinking near the material, prevent inhalation of dust, use personal protective equipment for skin and eyes
Potential Health Outcomes: Nausea, central nervous system depression, abdominal pain
Environmental Warning: Harmful to aquatic life with long-lasting effects
Loperamide Hydrochloride: 98-100%
Impurities: Typically less than 2% (includes unreacted starting material and trace solvents)
Inactive Components: None as supplied
Chemical Structure: Benzophenone derivative with a piperidine moiety; mono-hydrochloride salt
Molecular Weight: 513.5 g/mol
Eye Contact: Flush eyes with clean water for 15 minutes, remove contact lenses if present, seek medical attention if irritation remains
Skin Contact: Wash affected skin with soap and water, take off contaminated clothing, consult physician if irritation develops
Inhalation: Move subject to fresh air, provide oxygen if breathing is difficult, seek immediate medical help
Ingestion: Rinse mouth with water, do not induce vomiting unless directed by a medical professional, seek immediate medical care
Acute Symptoms: Watch for nausea, slowed breathing, sedation, or confusion after exposure
Suitable Extinguishing Media: Dry chemical, CO₂, or foam preferred; use water spray to cool containers
Combustion Hazards: Produces toxic fumes (hydrogen chloride, carbon monoxide, nitrogen oxides)
Firefighting Protection: Fire fighters need self-contained breathing apparatus and full protective suit
Flammability: Non-flammable under normal conditions, but dust may form explosive mixtures in air
Specific Measures: Remove containers from the fire zone if safe, keep cool with water mist
Personal Precautions: Isolate spill area, use gloves, protective eyewear, and dust mask to avoid contact and inhalation
Spill Cleanup: Sweep up material without generating dust, bag in containers for disposal, wash spill site with soapy water after cleanup
Environmental Controls: Do not allow spillage into drains or waterways, contain with absorbent material if necessary
Notification: Inform supervisory personnel and follow internal reporting guidelines if significant quantities are released
Handling: Avoid creating and inhaling dust, handle with appropriate PPE, keep well-ventilated workspace
Storage Conditions: Store locked up in tightly closed original container, in a cool, dry, well-ventilated place far from light and sources of ignition
Incompatible Substances: Strong acids and oxidizers
Safe Transfer: Use tools and safety procedures that minimize spillage and contact
Exposure Limits: No established occupational exposure limits for loperamide hydrochloride
Engineering Controls: Use local exhaust ventilation to maintain air levels below safe thresholds
Eye Protection: Safety glasses or goggles
Skin Protection: Laboratory-grade gloves and lab coat
Respiratory Protection: NIOSH-approved dust mask, especially for bulk-scale handling
Hygiene: Wash hands after handling, do not eat, drink or smoke near product
Appearance: White to off-white crystalline powder
Odor: None
pH: 4.0-6.0 in aqueous solution
Melting Point: 224-227°C
Boiling Point: Decomposes
Solubility: Soluble in water, slightly soluble in methanol, insoluble in ether
Vapor Pressure: Not applicable
Density: Approximately 1.2 g/cm³
Partition Coefficient: Log Kow around 4.6
Chemical Stability: Stable under normal temperatures and recommended storage conditions
Conditions to Avoid: High humidity, extreme heat, direct sunlight
Incompatible Materials: Strong oxidizing reagents, mineral acids
Hazardous Decomposition: Hydrogen chloride, carbon monoxide, carbon dioxide, nitrogen-containing gases
Polymerization: Not expected under normal handling
Acute Toxicity: LD50 (oral, rat): Data varies, ranges between 40-60 mg/kg
Chronic Toxicity: Extended exposure may affect liver and central nervous system; data on long-term exposure remains limited
Irritation/Corrosion: Mild skin and eye irritation in sensitive individuals
Sensitization: No data on allergic sensitization in humans, classified as low risk based on animal studies
Carcinogenicity: Not listed by IARC, NTP, OSHA
Reproductive Toxicity: Adverse fetal effects observed in animal studies at high doses; avoid use in pregnancy unless under medical advice
Other Effects: Overdose may cause life-threatening respiratory depression or paralytic ileus
Environmental Fate: Loperamide hydrochloride breaks down slowly in the environment, especially in water and soil
Bioaccumulation: Potential for bioaccumulation due to log Kow, significant impacts unlikely at environmental levels
Aquatic Toxicity: Harmful to fish and invertebrates; LC50 (Daphnia magna): reported in low mg/L range
Soil Mobility: Binds strongly to sediment and organic matter, low ground water mobility
Degradability: Limited data, does not biodegrade rapidly
Waste Disposal: Collect unused material in sealed, labeled containers, send to an approved hazardous waste facility
Environmental Precaution: Do not release to river, lake or sewer systems
Container Disposal: Triple rinse and offer clean containers for recycling or disposal according to local regulations
Legal Requirements: Consult with waste disposal contractor familiar with pharmaceutical waste
UN Number: Not regulated as a dangerous good for transport under ADR/RID, IMDG, or IATA
Shipping Name: Loperamide Hydrochloride (non-hazardous for transport)
Packaging Instructions: Tightly sealed and appropriately labeled packaging
Transport Class: Not assigned
Special Precautions: Protect from physical damage and excessive heat during transit
Status: Registered pharmaceutical active ingredient
Global Listings: Listed in chemical inventories for research and manufacturing;
Labeling: Classified as harmful (Xn) under EU regulations, requires hazard and precautionary statements
SARA Title III: Not listed
OSHA Hazardous Chemical: Yes
WHMIS (Canada): Classified as D2B – toxic material causing other toxic effects
Other Laws: Final user must ensure compliance with local, national, and international laws governing pharmaceuticals and hazardous chemicals
