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Product name: Melphalan Hydrochloride
Other names: Alkeran, L-PAM, Phenylalanine mustard hydrochloride
Recommended uses: Antineoplastic, chemotherapy agent
CAS number: 148-82-3
Manufacturer/Supplier: Pharmaceutical manufacturers and authorized distributors
Contact information: Detailed on relevant packaging or through the responsible supplier’s customer service department
Emergency phone number: Listed with supplier and on product shipment documents for 24-hour response
Synonyms: L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-, monohydrochloride
Classification: Acute toxicity (oral, dermal, inhalation), carcinogen, mutagen, reproductive toxin
Label elements: Danger symbol (skull and crossbones), Health hazard pictogram, Exclamation mark
Hazard statements: Causes serious health effects, may cause genetic defects, likely carcinogenic, toxic if swallowed, inhaled, or absorbed through skin
Precautionary statements: Wear protective equipment, avoid inhalation, prevent release to the environment, wash thoroughly after handling
Routes of entry: Ingestion, inhalation, dermal absorption
Potential health effects: Fatigue, bone marrow suppression, gastrointestinal issues, skin/sensitization risk, potential risk to unborn child
Chemical identity: Melphalan Hydrochloride
Formula: C13H18Cl2N2O2•HCl
Purity: Pharmaceutical grade, generally above 98%
Major components: Melphalan Hydrochloride – over 98% by weight
Impurities: Less than 2%, often unknown or proprietary
Other hazardous ingredients: None anticipated for the pure compound, but excipients may change by manufacturer
Inhalation: Move person to fresh air, monitor breathing, seek emergency medical help if symptoms develop
Skin contact: Remove contaminated clothing, rinse affected area with water for at least 15 minutes, obtain medical attention
Eye contact: Rinse immediately with plenty of water, keeping eyelids open, for at least 15 minutes, get professional medical assistance
Ingestion: Rinse mouth without inducing vomiting, drink water to dilute if person is conscious, go straight to the hospital or poison center
Advice for first responder: Protective gloves, eyewear, and clothing recommended during rescue efforts, avoid direct exposure, ER staff should know how to handle cytotoxic exposures
Suitable extinguishing media: Use dry powder, carbon dioxide, or foam for small fires; water spray for larger quantity but avoid water jet
Unsuitable extinguishing media: High-pressure water jets can spread powder
Hazardous combustion products: Hydrogen chloride, nitrogen oxides, carbon monoxide, possibly toxic smoke containing unknown compounds
Special protective equipment: Firefighters should use self-contained breathing apparatus, fully protecting suit, and chemical resistant gloves
Fire/explosion hazards: Low flammability, toxic fumes on combustion, avoid inhalation of fire-generated chemicals
Advice for firefighters: Use water spray to cool nearby containers
Personal precautions: Use chemical resistant gloves, gown, approved respirator, and goggles; restrict access to authorized responders
Environmental precautions: Contain spill, avoid entry into sewers, soil, or waterways, notify authorities in large releases
Clean-up methods: Scoop up spilled material with least dust, place in closed labeled containers, decontaminate area with appropriate agent, ventilate exposed area
Reference to other sections: See disposal and exposure controls for detailed management
Handling precautions: Handle in designated cytotoxic area, avoid inhalation and contact with skin or eyes, use containment and dust control; do not eat, drink, or smoke in handling area
Hygiene measures: Wash hands after use, remove protective equipment before leaving workspace
Storage conditions: Keep container tightly sealed, store in dry, cool, well-ventilated location away from incompatible substances such as oxidizers, acids, or bases
Specific end use: Prescription pharmaceuticals, trained personnel only
Engineering controls: Lab hoods, local exhaust, and negative pressure rooms reduce airborne risk
Occupational exposure limits: No specific OSHA or ACGIH levels set, minimize exposure as much as technically feasible
Personal protective equipment: Nitrile gloves, impermeable gown, closed shoes, chemical splash goggles or face shield, NIOSH-approved respirator for airborne particles
Environmental exposure controls: Specialized medical waste management, avoidance of wastewater contamination
Monitoring: Regular air and surface sampling recommended in handling areas
Appearance: White/off-white or slightly yellow powder/crystalline solid
Odor: Slight or not perceptible
Melting point: 200 – 202°C (dec)
Solubility: Freely soluble in water, sparingly soluble in alcohol, practically insoluble in chloroform, ether
pH: Neutral to slightly acidic in aqueous solution
Molecular weight: 336.2 (base); 305.2 (hydrochloride)
Partition coefficient: LogP near -1.46 (distribution at physiological pH)
Boiling point: Data not applicable (decomposes before boiling)
Vapor pressure: Negligible under standard temperature
Density: Data not specific; estimated for pharmaceutical powders
Other properties: Stable as a powder, sensitive to moisture and light, decomposes with time and temperature
Chemical stability: Stable when stored as recommended; decomposes on exposure to moisture, light, and heat
Reactivity: Incompatible with strong oxidizing agents, acids, bases, and reactive substances
Hazardous reactions: Practically non-reactive under normal storage; can generate hazardous fumes if heated strongly
Decomposition products: Hydrogen chloride, nitrogen oxides, carbon monoxide, carbon dioxide, and potentially mutagenic residues
Polymerization: Not a known risk
Acute toxicity: Toxic by ingestion, inhalation, dermal exposure; reference dose LD50 for rats: 7-9 mg/kg orally
Chronic effects: Mutagenic and carcinogenic effects seen in animal studies; linked to bone marrow depression in humans
Routes of exposure: Oral, inhalation, skin, eyes
Symptoms of exposure: Nausea, vomiting, diarrhea, mouth ulcers, skin rashes, suppressed immune response, risk of organ toxicity
Sensitization: May cause allergic skin reactions
Target organs: Bone marrow, gastrointestinal system, liver, immune system
Carcinogenicity: Classified as carcinogen (IARC Group 1, NTP known human carcinogen)
Ecotoxicity: Harmful to aquatic organisms, may disrupt microbial populations
Persistence and degradability: Likely to persist in environment, slow degradation
Bioaccumulation: Not expected to bioaccumulate in aquatic organisms
Mobility in soil: May be mobile, especially in water-soluble form
Other adverse effects: Long-term environmental effects not fully tested, prudent containment in all uses; avoid discharging into the environment
Waste treatment methods: Collect and dispose of as cytostatic medical waste through licensed contractors
Special precautions: Use puncture-resistant containers, label as cytotoxin, incinerate at high temperature
Additional notes: Do not dispose of in regular trash, sink, or sewer systems
UN number: UN 2811 (for toxic solids, organic, n.o.s.)
Proper shipping name: Toxic solid, organic, n.o.s. (Melphalan Hydrochloride)
Transport hazard class: 6.1 (Toxic substances)
Packing group: II (medium hazard)
Marine pollutant: Not classified, but avoid release to marine environment
Label requirements: Toxic (skull and crossbones), proper handling and documentation, secure packaging to prevent breakage and spills
Special precautions: Only trained carriers; secure upright containers; protect from physical damage and extreme temperatures
Regulatory references: IATA, IMDG, US DOT, ADR/RID for cross-border movement
Federal regulations: Covered under OSHA Hazard Communication Standard; listed as carcinogen by NTP, IARC, and US EPA
State regulations: Listed as hazardous by California Proposition 65 and similar state laws
Labeling: Must carry cytotoxic warnings, R/S phrases, pictograms
Workplace regulation: Exposure should comply with OSHA, NIOSH, and state standards for cytotoxic agents
Other international considerations: Registered under international conventions relating to pharmaceutical chemical safety; subject to REACH and CLP in the EU; inclusion in WHO Model List of Essential Medicines with strict handling and disposal recommendations
