Material Safety Data Sheet (MSDS): Phendimetrazine

Identification

Product Name: Phendimetrazine
Synonyms: 3,4-Dimethyl-2-phenylmorpholine; phendimetrazine tartrate (salt form)
Chemical Family: Morpholine derivatives
CAS Number: 634-03-7 (free base); 24369-23-1 (tartrate form)
Intended Use: Pharmaceutical, prescribed for weight management
Manufacturer: Supplied by registered pharmaceutical companies and distributors
Contact Information: Emergency phone numbers and contact details typically listed on packaging or label

Hazard Identification

Hazard Classification: Schedule III controlled substance (US); harmful if swallowed, suspected of causing genetic defects; may cause dependency
GHS Classification: Acute toxicity (oral, Category 4); specific target organ toxicity (repeated exposure, Category 2)
Signal Word: Warning
Hazard Statements: Harmful if swallowed; causes respiratory and central nervous system stimulation; may aggravate cardiac conditions
Precautionary Statements: Avoid exposure without adequate ventilation; handle with care due to potential for abuse
Other Hazards: Chronic exposure linked to risk of dependency, high blood pressure, insomnia, and rapid pulse

Composition / Information on Ingredients

Chemical Name: Phendimetrazine
Chemical Formula: C12H17NO
Concentration: Pharmaceutical-grade tablets/capsules vary (commonly 35mg base per unit, or equivalent tartrate salt)
Impurities and Additives: Trace excipients such as microcrystalline cellulose, magnesium stearate, or lactose in commercial formulations
Mixture: Ingredient percentages available in prescription-strength formulations; single active substance in pure sample

First Aid Measures

Eye Contact: Rinse eyes cautiously with water for at least 15 minutes, remove contact lenses if possible, secure medical attention
Skin Contact: Remove contaminated clothing, wash skin with soap and water thoroughly, obtain medical advice if reaction occurs
Inhalation: Remove patient to fresh air immediately, monitor for signs of CNS stimulation or respiratory distress, provide oxygen if breathing is difficult, seek emergency care
Ingestion: Rinse mouth, do not induce vomiting, seek medical assistance immediately; monitor cardiovascular function closely
Major Symptoms: Tremors, nervousness, increased blood pressure, chest pain, insomnia; report and monitor for abnormal heart rhythm

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, CO₂, water spray, or appropriate foam
Fire Hazards: May emit toxic fumes such as nitrogen oxides, carbon monoxide under fire conditions
Protective Equipment: Self-contained breathing apparatus, full protective suit to avoid inhaling decomposition products
Firefighting Instructions: Move containers from fire area if safe, avoid run-off entering drains or water courses, control fire using least aggressive method compatible with safety
Explosion Risk: Under severe heating, pressure build-up possible in tightly closed containers

Accidental Release Measures

Personal Precautions: Use personal protective equipment including gloves, eyewear; avoid inhalation of dust or vapors
Environmental Precautions: Prevent product from entering drains or waterways; contain released substance using absorbent, inert material
Methods for Cleanup: Scoop or sweep up, place in clearly labeled container for disposal according to local, state, federal regulations
Decontamination: Wash area with plenty of water and detergent, ventilate well
Special Considerations: Control dust, prevent contact with incompatible substances, use closed systems if possible

Handling and Storage

Handling: Work under chemical fume hood, avoid ingestion, inhalation, and contact with skin, eyes; do not eat or drink in work area
Storage: Store at controlled room temperature (20–25°C/68–77°F); keep in tightly closed, light-resistant containers; restrict access to authorized personnel
Storage Incompatibilities: Keep separate from strong oxidizers, acids, or materials sensitive to nitrogen-containing compounds
Special Precautions: Store according to DEA and controlled substance regulations; record-keeping mandatory
Other Notes: Protect from moisture, keep away from ignition sources, use secondary containment if necessary

Exposure Controls and Personal Protection

Engineering Controls: Chemical fume hood, proper ventilation, closed handling systems
Respiratory Protection: NIOSH-approved full-face respirator for particulate or vapor exposure above recommended limits
Skin Protection: Protective chemical-resistant gloves (nitrile, neoprene), lab coat, long sleeves
Eye Protection: Safety goggles or face shield
Hygiene Measures: Wash hands thoroughly before breaks and after handling, avoid direct contact with product
Exposure Limits: Occupational exposure limits not specifically established; recommend minimizing exposure as much as possible

Physical and Chemical Properties

Appearance: White to off-white crystalline powder or white solid
Odor: Practically odorless
Molecular Weight: 191.27 g/mol (free base)
Melting Point: 172–174°C (tartrate salt), range varies with form
Boiling Point: Not available (compound decomposes before boiling)
Solubility: Freely soluble in water (tartrate form), sparingly soluble in alcohol and chloroform
pH: Not applicable (solid), solutions may have acidic pH due to tartrate
Partition Coefficient (Log Kow): Not readily available, expected moderate lipophilicity
Vapor Pressure: Negligible at ambient temperatures
Flash Point: Data not available, not considered flammable under standard laboratory conditions

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Conditions to Avoid: Excessive heat, open flames, humid or moist environments
Incompatible Materials: Strong acids or bases, oxidizers, some metals
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, irritant fumes upon combustion
Polymerization: No known hazardous polymerization
Special Reactivity: Avoid contact with incompatible substances or mixing with other pharmaceuticals

Toxicological Information

Acute Toxicity: Reported oral LD₅₀ (rat): 980 mg/kg; lower values in some animal studies
Chronic Effects: Prolonged or repeated administration may lead to dependence, anxiety, hypertension, and cardiovascular disturbances
Routes of Exposure: Inhalation, ingestion, dermal, ocular
Symptoms of Exposure: Agitation, insomnia, irritability, tremors, rapid heartbeat, increased blood pressure, dry mouth
Carcinogenicity: Animal data inconclusive; no IARC, NTP, or OSHA classification as carcinogen
Mutagenicity: Limited evidence for mutagenicity in vitro; insufficient human data
Reproductive Toxicity: Unknown effects, not recommended during pregnancy, may affect fetal development
Target Organs: Central nervous system, cardiovascular system
Other Risks: Substance misuse or abuse may result in psychological or physical dependency

Ecological Information

Ecotoxicity: No comprehensive ecotoxicological studies available; similar compounds show toxicity to aquatic life at high concentrations
Persistence and Degradability: Partially biodegradable under environmental conditions; parent compound and metabolites may persist in wastewater
Bioaccumulation Potential: Uncertain; moderate lipophilicity may lead to some retention in tissues
Mobility in Soil: Likely mobile in water solutions; potential for leaching if released
Other Harmful Effects: Pharmaceutical residues in surface water may disrupt endocrine and behavioral patterns in exposed organisms
Special Environmental Considerations: Avoid discharge into natural waters, follow appropriate protocols for pharmaceutical waste

Disposal Considerations

Waste Management: Treat as hazardous pharmaceutical waste; dispose according to DEA, federal, and state regulations
Disposal Containers: Use sealed, clearly labeled hazardous waste containers; prevent unauthorized access
Incineration: High-temperature incineration recommended in permitted facilities
Sewage Disposal: Do not flush or wash into public drains or water systems
Contaminated Packaging: Rinse and dispose as chemical waste, label if residual risk remains
Documentation: Maintain full disposal records for regulatory compliance

Transport Information

UN Number: Not assigned for pharmaceutical forms; may be regulated as prescription drug or hazardous material
Transport Hazard Class: Not applicable to finished pharmaceutical products, but bulk shipments should comply with hazardous material regulations
Packing Group: Not classified for finished dosage forms
Proper Shipping Name: Phendimetrazine preparations; may be classified as prescription medication or Schedule III substance depending on jurisdiction
Special Transport Precautions: Secure packaging, restricted access, compliance with national and international controlled substance laws
Environmental Hazards: Prevent leaks or spills during transit; notify authorities of significant incidents

Regulatory Information

Controlled Status: Schedule III (United States Controlled Substances Act), prescription-only medicine
OSHA Regulation: General workplace safety applies; not specifically listed
TSCA Listing: Not listed for commercial chemical inventory purposes
SARA Title III: No specific reportable quantities
FDA Status: Approved for certain medical uses under prescription, subject to federal and state pharmaceutical regulations
Other Regulatory Notes: Strict record-keeping, reporting, and access controls required for legal handling and distribution; some countries classify under similar psychotropic substance laws