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Product Name: Domperidone
Chemical Name: 5-chloro-1-[1-[3-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1,3-dihydro-2H-benzimidazol-2-one
Synonyms: Motilium, Motilidone, Motoric, DMP-D
CAS Number: 57808-66-9
Use: Pharmaceutical, antiemetic and prokinetic agent for relief of nausea and gastric discomfort
Supplier Details: Pharmaceutical manufacturers or distributors’ information printed on the packaging
Emergency Contact Number: Local poison center or company emergency line listed with shipment or SDS database
Hazard Class: Not classified as a hazardous mixture under GHS for most end-user forms
Main Health Hazards: Irritation to eyes, skin, or respiratory system by dust or powder; harmful if swallowed in large amounts; risk of cardiac arrhythmia at high doses
Symbol: None assigned for solid tablets, may use exclamation mark for powder
Precautionary Statements: Avoid dust inhalation, avoid skin/eye contact, wash hands after handling bulk or powder
Acute Risks: Nausea, headache, dizziness if ingested in large amounts; possible skin redness with contact
Chronic Exposure Risks: Long-term exposure at high doses may impact heart rhythm in susceptible users; laboratory animal data show mild liver effects in high, prolonged exposure
Main Ingredient: Domperidone (CAS 57808-66-9)
Typical Purity: 98% or greater in active pharmaceutical ingredient form
Impurities: Process-related organic impurities (usually less than 0.1%)
Excipients: Tablet forms include lactose monohydrate, maize starch, povidone, magnesium stearate, hypromellose, or similar, percentages specific to brand/formulation
Concentration Ranges: Finished dosage forms contain 5-10 mg domperidone per tablet/capsule/suspension dose unit
Inhalation: Move person to fresh air; seek medical attention if respiratory irritation or symptoms appear
Skin Contact: Wash exposed area thoroughly with soap and water; remove contaminated clothing; seek medical advice if irritation persists
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present; consult ophthalmologist if symptoms continue
Ingestion: Rinse mouth with water; induce vomiting only if instructed by medical personnel; monitor for symptoms and contact poison center or emergency services
Suitable Extinguishing Media: Water spray, foam, dry chemical, carbon dioxide
Special Hazards: Combustion of bulk powder gives off carbon oxides, nitrogen oxides, and hydrochloric acid fumes
Protective Equipment: Firefighters should wear self-contained breathing apparatus and protective clothing
Additional Guidance: Remove containers from fire area where safe; avoid breathing smoke, use water spray to cool exposed containers
Personal Precautions: Avoid generating dust; ventilate area; use personal protective equipment—gloves, lab coat, dust mask
Environmental Precautions: Prevent further spillage; avoid releasing into drains and surface water
Cleaning Methods: For powder: sweep up and place in suitable, labeled container for disposal; wipe area with damp cloth
Decontamination: Dispose all cleanup equipment as hazardous waste if significant amounts of active ingredient are involved
Safe Handling: Handle in well-ventilated area; avoid skin and eye contact with raw bulk or powder; wash hands after use
Storage Conditions: Keep tightly closed in original container, protected from light and moisture; store at 15–30 °C (59–86 °F) depending on labeling
Incompatible Substances: Strong oxidizing agents; strong acids; avoid storing near incompatible chemicals
Technical Measures: Keep away from food and drink; employ engineering controls or exhaust where dust generation could occur
Engineering Controls: Use standard laboratory or pharmaceutical plant ventilation; local exhaust for powder handling
Personal Protection: Gloves (nitrile or latex), safety goggles, lab coat or protective clothing; dust mask for powder
Occupational Exposure Limits: No domestic or international occupational limit established for domperidone as of latest official sources; keep workplace airborne concentrations as low as possible
General Hygiene: No eating or drinking in handling area; wash hands before breaks or leaving work station
Appearance: White or almost white crystalline powder, odorless
Molecular Formula: C22H24ClN5O2
Molecular Weight: 425.9 g/mol
Melting Point: 242–246 °C (standard reference range)
Solubility: Practically insoluble in water; soluble in methanol, ethanol, and acetone
pH: Not applicable for pure powder
Vapor Pressure: Not volatile at room temperature
Partition Coefficient: Log P (octanol/water) about 3.9
Stability: Stable under normal storage and handling conditions
Chemical Stability: Remains stable under standard storage, handling, and processing temperatures
Conditions to Avoid: Direct sunlight; moisture; excessive heat
Materials to Avoid: Strong acids, bases, and oxidizers can decompose active material
Hazardous Decomposition Products: Burning or decomposition may yield toxic fumes including nitrogen oxides, carbon monoxide/dioxide, and hydrogen chloride gas
Reactivity: Not reactive in normal conditions, but avoid mixing with incompatible chemicals
Acute Toxicity: Oral LD50 in rodents reported as 200–300 mg/kg; low risk from brief inhalation or skin exposure in workplace settings
Symptoms of Overdose: Drowsiness, disorientation, seizures, dry mouth, confusion, tremor, especially in high, accidental exposure
Skin Irritation: Unlikely unless exposed to large amounts of powder, may cause mild irritation
Eye Irritation: Dust contact can lead to redness or discomfort
Chronic Effects: High repeated doses in laboratory studies linked to prolactin elevation, possible arrhythmias, mild hepatic effects
Sensitization: No robust evidence of sensitization in humans
Environmental Toxicity: Ecotoxicity data limited; possible risk to aquatic organisms at elevated concentrations in wastewater
Persistence and Degradability: Data suggest partial biodegradation in standard sewage treatment
Bioaccumulation: Low potential for bioaccumulation under ordinary environmental exposure
Mobility in Soil: Not substantially mobile; tends to sorb to soil particles
Other Effects: Typical pharmaceutical wastewater monitoring practices apply to manage potential trace releases
Disposal Methods: Dispose as pharmaceutical waste according to local regulatory requirements; incineration preferred for significant quantities
Packaging Disposal: Render packaging unusable and dispose as chemical waste to safeguard against misuse
Waste Codes: Follow national or regional codes for toxic/hazardous pharmaceutical waste (example: EWC 18 01 08 for pharmaceuticals except cytotoxics in Europe)
Special Precautions: Avoid direct disposal to drains or natural water bodies
UN Number: Not regulated as a dangerous good for ground, air, or sea transport in finished dosage forms
Shipping Name: Domperidone, solid
Transport Hazard Class: Not classified
Packing Group: Not assigned
Special Precautions: Prevent release of bulk powder during transit; keep containers tightly closed, protect from moisture and abuse
Labeling: General chemical labeling required for bulk shipments; retail units shipped as regular merchandise
FDA Status: Approved prescription medication in many countries; labeling required for pharmaceutical use
EU Classification: Prescription-only medicine; chemical not classified as hazardous for transport, but workplace safety applies
Workplace Regulations: Employers follow local workplace health and safety laws for chemical handling
Inventories: Listed in national/international chemical inventories where used for research or manufacturing
Restrictions: Use restricted for specific clinical indications due to cardiac risk concerns in certain populations as noted in updated regulatory reviews
