Material Safety Data Sheet: Metaraminol Bitartrate

Identification

Product Name: Metaraminol Bitartrate
Chemical Name: (1R,2S)-2-Amino-1-(3-hydroxyphenyl)propan-1-ol hydrogen 2,3-dihydroxybutanedioate
CAS Number: 15292-97-2
Recommended Uses: Pharmaceutical ingredient for vasopressor formulations
Manufacturer Details: Listed per source supplier, including emergency phone numbers and addresses specific to manufacturer location

Hazard Identification

GHS Classification: Acute toxicity (oral), Skin sensitization category 1, Eye Irritation Category 2A
Signal Word: Warning
Hazard Statements: Harmful if swallowed; causes eye irritation; may cause allergic skin reaction; may cause central nervous system effects
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust; wash thoroughly after handling; wear protective gloves and eye/face protection

Composition / Information on Ingredients

Chemical: Metaraminol Bitartrate
CAS Number: 15292-97-2
Purity: Typically ≥98% by weight
Impurities: Trace organic and inorganic residues, limits defined by specification; quantities not considered to alter health risks

First Aid Measures

Inhalation: Take person to fresh air. Seek medical attention if symptoms develop. Loosen tight clothing.
Skin Contact: Remove contaminated clothing. Rinse skin with plenty of water and, if irritation persists, call medical services.
Eye Contact: Flush eyes with plenty of running water for several minutes. Remove contact lenses if present. Continue flushing and obtain medical help.
Ingestion: Rinse mouth with water, do not induce vomiting. Get immediate medical attention. Provide label or SDS to medical staff.
Note for Physician: Treat symptomatically and provide supportive measures for vasopressor effects and central nervous disturbances.

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, carbon dioxide, alcohol-resistant foam, water spray.
Unsuitable Media: Powerful water jets can spread material and should not be used.
Hazards from Combustion: Emits irritant or toxic gases such as nitrogen oxides, carbon monoxide, carbon dioxide.
Protective Equipment for Firefighters: Use self-contained breathing apparatus, full protective clothing.
Other Information: Cool exposed containers with water spray to prevent bursting. Avoid breathing vapors created by combustion.

Accidental Release Measures

Personal Precautions: Wear NIOSH-approved respirator, chemical safety goggles, and compatible gloves. Evacuate unnecessary personnel.
Environmental Precautions: Prevent powder from entering water, drains, sewers, and soil. Alert authorities if material enters environment in large amounts.
Methods for Cleaning Up: Sweep up without generating dust, place in appropriate closed container for disposal. Rinse residue with plenty of water.
Other Advice: Ensure adequate ventilation in area. Decontaminate surfaces according to institutional procedures. Dispose of cleanup materials in accordance with national regulations.

Handling and Storage

Handling: Use only in well-ventilated areas, avoid inhaling dust or contact with skin, eyes, and clothing. Prevent static discharge and keep away from ignition sources.
Hygiene Measures: Wash hands thoroughly after handling. Do not eat, drink, or smoke while handling product.
Storage Conditions: Keep container tightly closed in a dry, cool, and well-ventilated place. Protect from light, moisture, and incompatible substances such as strong oxidizers.
Incompatible Materials: Avoid contact with strong acids, strong bases, strong oxidants, and chemicals prone to react with phenols or amines.

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established OSHA, NIOSH, or ACGIH limits for metaraminol bitartrate; use conservative limits for similar amines.
Engineering Controls: Use safety cabinets, laboratory fume hoods, and local exhaust ventilation.
Personal Protective Equipment: Splash-resistant goggles for eye protection, chemical-resistant gloves (such as nitrile or neoprene), laboratory coat or apron, and NIOSH-approved particulate respirator (P2 or higher), especially when dust generation is likely.
Environmental Controls: Prevent release into the environment by using appropriate filtration and secure containment.

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or slightly characteristic odor
pH: 3 – 5 (in aqueous solution)
Melting Point: Approximately 120-140°C (decomposition may occur at higher end)
Boiling Point: Not available (decomposes before boiling)
Flash Point: Not determined for solid product
Solubility: Freely soluble in water, slightly soluble in alcohol, almost insoluble in ether
Vapor Pressure: Not applicable (solid at room temperature)
Density: Not specifically determined; estimated at about 1.4 g/cm³
Partition Coefficient (log Kow): Not established
Other Properties: Stable under recommended storage conditions, hygroscopic.

Stability and Reactivity

Chemical Stability: Stable under standard ambient conditions with proper storage (protected from moisture and light).
Conditions to Avoid: High temperature, exposure to acids, bases, oxidizing agents, and moisture.
Incompatible Materials: Strong oxidizers, acids, bases, and agents that react with alcohol or amine functional groups.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, toxic fumes under fire or thermal decomposition.
Possibility of Hazardous Reactions: No hazardous polymerization expected; may react with potent oxidizers.

Toxicological Information

Acute Toxicity: Harmful if swallowed. Precise oral LD50 for rats ranges from 100 mg/kg to 300 mg/kg as indicated in published studies.
Routes of Exposure: Inhalation, ingestion, skin, and eye contact;
Short-term Effects: Nausea, headache, CNS stimulation, local irritation to skin/eyes.
Long-term Effects: Chronic exposure unknown; repeated ingestion or exposure can affect cardiovascular and nervous systems, with possible sensitization.
Carcinogenicity/Mutagenicity: No evidence available for carcinogenic or mutagenic risks in humans per REACH submission and IARC.
Reproductive Toxicity: Not established in animal studies, not expected at workplace exposure levels.

Ecological Information

Ecotoxicity: No specific data on aquatic or terrestrial toxicity; expected to be low in normal usage.
Persistence and Degradability: Biodegradability studies limited, but compound anticipated to degrade under aerobic conditions due to aromatic and amine structures.
Bioaccumulation Potential: Log Kow not identified, risk of bioaccumulation is low based on structure and solubility.
Mobility in Soil: Mobile in water due to high solubility, potential for leaching, but will dilute rapidly in larger bodies of water.
Other Adverse Effects: Avoid releasing substantial quantities into the environment as a precaution; report unintended discharges according to local guidelines.

Disposal Considerations

Disposal Methods: Collect waste in tightly sealed, clearly labelled containers approved for hazardous chemical disposal. Dispose of by incineration in authorized facilities or through chemical waste contractors.
Unsuitable Disposal: Do not allow disposal by landfill, drain, or release to surface water/sewer systems.
Contaminated Packaging: Rinse with water, render unusable, and dispose as hazardous waste in accordance with local and national regulations.
Waste Regulations: Handle as pharmaceutical waste. Contact local environmental authorities for specific rules governing disposal in the jurisdiction.

Transport Information

UN Number: Not regulated as a dangerous good by ADR, IATA, or IMDG.
Proper Shipping Name: Metaraminol Bitartrate, not regulated
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: None identified for transport purposes
Special Precautions: Prevent exposure to moisture and physical damage during transport; keep container intact

Regulatory Information

International Inventory Status: Exempt or regulated as a pharmaceutical ingredient under REACH (Europe), DSL (Canada), TSCA (USA).
Other Regulations: Subject to workplace control under OSHA Hazard Communication Standard (29 CFR 1910.1200), and may require reporting under CERCLA due to volume.
EU Classification: Regulated as a medicinal product, not classified as hazardous under CLP except at bulk chemical level.
Labeling Requirements: Comply with hazard communication standards and include appropriate warnings for acute toxicity, skin sensitization, and eye irritation.
Additional Requirements: Specific regulations apply for APIs (Active Pharmaceutical Ingredients) in transportation and handling within licensed pharmaceutical facilities.