Material Safety Data Sheet (MSDS) - Pethidine

Identification

Product Name: Pethidine Hydrochloride
Chemical Name: 4-Phenylpiperidine-4-carboxylic acid ethyl ester hydrochloride
Synonyms: Meperidine, Demerol
CAS Number: 57-42-1
Recommended Use: Analgesic (pain relief medication, pharmaceutical preparation)
Manufacturer/Supplier: Pharmaceutical companies, hospital pharmacies (details as per specific supplier label)
Emergency Contact: Refer to institutional protocols or poison control center for accidental or intentional exposure
Address: As shown on product packaging

Hazard Identification

GHS Classification: Acute toxicity (oral), Category 3; Acute toxicity (dermal), Category 3; Acute toxicity (inhalation), Category 3; Narcotic effects
Signal Word: Danger
Hazard Statements: Toxic if swallowed, in contact with skin or if inhaled; causes central nervous system and respiratory depression; may cause convulsions at high doses
Precautionary Statements: Avoid all unnecessary exposure; prevent inhalation of dust or aerosols; avoid skin and eye contact; use only in a well-ventilated area; seek medical advice if feeling unwell
Other Risks: Addictive properties, potential for misuse and overdose, risk to people with respiratory conditions

Composition / Information on Ingredients

Chemical Ingredient: Pethidine hydrochloride
Concentration: Pure active substance or as listed on dosage form (e.g., 50 mg or 100 mg per milliliter)
CAS Number: 57-42-1
Impurities and Additives: May contain sodium chloride, preservatives, water for injection in pharmaceutical forms
Other Ingredients: Inert fillers/excipients as per dosage form

First Aid Measures

Inhalation: Move the person to fresh air immediately, ensure airways remain clear, seek medical assistance; artificial respiration may be needed if breathing stops
Skin Contact: Remove contaminated clothing; wash affected area with plenty of water and soap; seek prompt medical care for symptoms
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy to do; consult medical personnel
Ingestion: Rinse mouth, offer water if the person is conscious, do not induce vomiting, transport to emergency medical facility without delay
Most Important Symptoms: Symptoms include CNS depression, slow or irregular breathing, confusion, drowsiness, possible convulsions, pinpoint pupils
Special Note: Naloxone may be used by emergency staff to treat suspected overdose

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam, especially in pharmaceutical storage areas
Special Hazards: Combustion creates toxic fumes: carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride
Protective Equipment for Firefighters: Utilize self-contained breathing apparatus and full protective gear; avoid inhaling combustion products
Specific Fire & Explosion Hazards: Fine dust in air can pose an explosion risk; handle powder formulations with grounding and spark protection
Other Considerations: Evacuate personnel to a safe distance; prevent run-off water from contaminating public water supplies

Accidental Release Measures

Personal Precautions: Evacuate unnecessary personnel, secure area, wear suitable gloves, chemical goggles, lab coat, and dust mask or respirator
Environmental Precautions: Prevent entry into drains, soil, or watercourses; notify authorities in case of significant spill
Methods for Cleanup: Ventilate area, cover spill with inert absorbent (sand, earth, vermiculite), collect residue in tightly closed container for disposal, thoroughly clean area with detergent
Special Measures: Avoid raising dust, use tools and containers that do not spark, decontaminate tools and protective equipment after clean-up

Handling and Storage

Precautions for Safe Handling: Minimize generation of dust, avoid direct contact, handle only in well-ventilated places or fume hood, use personal protection, do not eat, drink, or smoke while handling
Conditions for Safe Storage: Store locked up, away from unauthorized personnel, in original container, out of reach of children, away from heat, sparks, open flames, or strong oxidizing agents
Storage Area Requirements: Cool, dry, well-ventilated, monitored for security, compliant with controlled substances regulations
Incompatibilities: Avoid contact with strong acids, alkalis, oxidizing agents, and reducing agents
Special Advice: All handling and storage should comply with controlled drug regulations due to abuse and theft risk

Exposure Controls and Personal Protection

Exposure Limits: Occupational exposure limits not well established; minimize exposure as much as possible
Engineering Controls: Use fume hoods, closed systems, or local exhaust ventilation for powder handling; monitor air levels in production areas
Personal Protective Equipment (PPE): Wear chemical-resistant gloves, safety goggles, laboratory coat, and, in case of dust, a respirator approved for organic compounds
Hygiene Measures: Remove contaminated clothing, wash hands thoroughly after use, prohibit eating or drinking in work area, shower after significant exposure
Environmental Controls: Prevent entry of waste or wash water into sewers or waterways

Physical and Chemical Properties

Form: Crystalline powder (pure substance); clear solution (injectable preparation)
Color: White or almost white
Odor: Nearly odorless
Boiling Point: Decomposes before boiling
Melting Point: 186–189°C (pethidine hydrochloride)
Solubility: Highly soluble in water; soluble in alcohol and chloroform
pH: Slightly acidic (solution form)
Relative Density: Approx. 1.315 g/cm³
Vapor Pressure: Not volatile in normal conditions
Other Properties: Pharmacologically active; reacts with strong oxidizers

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions; avoid prolonged exposure to light, moisture
Reactivity: Not reactive under normal handling; reacts with strong oxidizers
Decomposition Products: Toxic gases possible at high temperatures: carbon monoxide, carbon dioxide, nitrogen oxides, hydrochloric acid
Conditions to Avoid: Heat, flames, exposure to light, incompatible materials
Polymerization: Not known to undergo hazardous polymerization

Toxicological Information

Routes of Exposure: Ingestion, inhalation, dermal, ocular
Acute Toxicity: LD50 Oral (rat): ~500 mg/kg; highly toxic, especially by ingestion or injection
Short-term Effects: Euphoria, dizziness, sedation, respiratory depression, nausea, vomiting, blurred vision, hypotension, bradycardia, seizures, coma possible at high doses
Chronic Effects: Habit-forming, risk of dependence and addiction, cognitive and psychomotor impairment, possible liver and kidney effects with long-term misuse
Sensitization: Rare skin or allergic reactions have occurred
Target Organs: Central nervous system, respiratory system, heart, liver, kidneys
Carcinogenicity/Mutagenicity: Not classified as carcinogen, not expected to be mutagenic
Other Toxic Effects: Fetal risk if used in late pregnancy, potential for neonatal withdrawal

Ecological Information

Ecotoxicity: Limited environmental data; expected toxicity to aquatic organisms at high concentrations
Persistence and Degradability: Pharmaceuticals may persist in water; degraded slowly by microbial action
Bioaccumulation: Not likely to bioaccumulate significantly
Mobility in Soil: Likely to migrate through porous soils if released, due to solubility in water
Other Effects: Potential risk to aquatic and terrestrial organisms if released into waterways; avoid large-scale environmental contamination

Disposal Considerations

Waste Disposal Method: Use incineration as controlled drug waste, in accordance with local, regional, and national regulations
Product/Container Disposal: Do not reuse containers; triple rinse with compatible solvent; send for authorized pharmaceutical waste disposal
Special Requirements: Comply with controlled drugs legislation; never dispose of through sinks or regular trash
Other Considerations: Institutional procedures may require logging, tracking, and witness of disposal for accountability
Advice: Consult guidelines from environmental protection agencies and health authorities for best practices

Transport Information

UN Number: UN 2811 (toxic solid, organic, n.o.s., for pethidine base)
Proper Shipping Name: Toxic solid, organic, n.o.s. (contains pethidine)
Hazard Class: 6.1 (toxic substances)
Packing Group: II or III, as per quantity and formulation
Special Precautions: Secure packaging, tamper-evident, carried by authorized personnel
Environmental Hazard: Not classified, but large spills can threaten aquatic life
Transport Label: Toxic substance; follow all national and international controlled drug regulations
Regulatory References: ADR/RID, IATA, IMDG, U.S. DOT

Regulatory Information

Status: Controlled drug under national and international narcotics law (e.g., Schedule II under US DEA, Schedule 2 in UK Misuse of Drugs Act)
Applicable Legislation: Compliance needed with FDA (USA), EMA (Europe), Health Canada (Canada), TGA (Australia), and other regulatory bodies
Labelling Requirements: Must include hazard warnings, child-resistant packaging, security features, batch traceability
Occupational Requirements: Staff must follow institutional procedures for controlled substances, including training and documented handling processes
Other Notes: Recordkeeping required for receipt, use, and final disposal; regular audits; mandatory reporting of losses or suspected theft
Safety Data Sheet Reference: Consult country-specific workplace safety and poison control resources for additional requirements