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Product Name: Methyldopa Hydrate
Chemical Name: alpha-methyl-3,4-dihydroxyphenylalanine hydrate
Chemical Family: Catecholamine analog
Molecular Formula: C10H13NO4 · xH2O
CAS Number: 41372-08-1 (hydrate)
Synonyms: Aldomet Hydrate, Dopamet Hydrate
Recommended Use: Antihypertensive agent in pharmaceutical formulations
Company Identification: Manufacturer or supplier contact information appears on sourced packaging and shipping records
Emergency Phone: Refer to local hazardous material emergency numbers or company contacts
GHS Classification: Not classified as hazardous based on available data
Pictogram: None assigned under GHS requirements
Signal Word: None
Hazard Statements: Not known to be acutely toxic; may cause skin and eye irritation; inhalation could lead to mild discomfort in sensitive individuals
Precautionary Statements: Avoid breathing dust; prevent contact with eyes or skin; wash thoroughly after handling; use personal protective equipment if exposure risk exists
Health Effects: May trigger allergic reactions in susceptible individuals; accidental ingestion may result in hypotension, headache, or lethargy
Environmental Hazards: Studies show low environmental toxicity; persistent exposure or spills near water sources could disturb aquatic organisms in high concentrations
Chemical Ingredient: Methyldopa Hydrate
CAS Number: 41372-08-1
Percentage: Not less than 98% pure (pharmaceutical grade)
Additives/Excipients: None found in analytical sample for raw material
Impurities: Levels well below ICH impurity thresholds; comprehensive certificate of analysis provides additional breakdown on request
Eye Contact: Rinse eyes gently with plenty of water for several minutes, seeking medical advice if irritation persists
Skin Contact: Remove contaminated clothing, wash skin with soap and water; seek medical attention for ongoing redness or discomfort
Inhalation: Move to area with fresh air; medical attention necessary for persistent coughing, difficulty breathing, or dizziness
Ingestion: Do not induce vomiting; rinse mouth with water and seek emergency medical assistance immediately; provide healthcare staff information on quantity and formulation
Acute Symptoms: Hypotension, drowsiness, nausea, allergic rash may manifest in cases of significant overdose or direct contact in sensitive individuals
Suitable Extinguishing Media: Dry chemical, CO2, regular foam, or water spray
Unsuitable Extinguishing Media: Direct water jet on chemical fires can cause dispersal of powder
Specific Hazards: Combustion yields carbon oxides, nitrogen oxides, potentially irritating or toxic fumes
Protective Equipment for Firefighters: Full protective clothing and self-contained breathing apparatus due to risk of exposure to combustion byproducts
Additional Notes: Containers exposed to fire heat risk rupture; move if safely possible
Personal Precautions: Wear powder-resistant gloves, lab coat, splash-proof eye protection, and a particle respirator in enclosed areas
Environmental Precautions: Prevent spill from entering drains or natural water sources
Clean-Up Procedures: Avoid dust generation; sweep up and store in closed, labeled containers for proper disposal; ventilate area well once cleanup is finished
Handling Spills: Use water-dampened cloths for final wipe-down to prevent powder residue
Safe Handling Practices: Minimize powder dust in air; avoid eating, drinking, or smoking while handling; always use PPE
Storage Conditions: Keep container tightly closed in cool, dry, and well-ventilated place; protect from sunlight and moisture; recommended storage temperature between 2°C and 8°C
Incompatible Materials: Strong oxidizers, acids, or bases
Packing Materials: Use of glass, polyethylene, or approved chemical-resistant containers
Special Precautions: Store away from food or animal feed items; clear labeling prevents accidental misuse
Occupational Exposure Limits: No ACGIH or OSHA limits set for methyldopa hydrate; follow internal company exposure guidelines if available
Engineering Controls: Use local exhaust, chemical hoods, or work in ventilated areas
Personal Protective Equipment: Protective gloves (nitrile or latex), lab coat, safety goggles; for dusty operations, use a NIOSH-approved particle respirator
Hygiene Measures: Wash hands thoroughly after handling; launder contaminated clothing before reuse
Appearance: White to off-white crystalline powder
Odor: Odorless or slight characteristic smell
pH (1% solution): Typically between 4.5 and 6.5
Melting Point/Range: 300°C (decomposes)
Boiling Point: Not applicable; decomposes prior
Solubility in Water: Freely soluble
Partition Coefficient (log Kow): -2.42 (estimated)
Vapor Pressure: Negligible
Flash Point: Not flammable in standard handling
Relative Density: Approximately 1.3 g/cm³ at 20°C
Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: Not considered reactive under normal conditions
Hazardous Reactions: No significant hazardous polymerization anticipated
Conditions to Avoid: Excessive heat, exposure to moisture, contact with strongly acidic or oxidizing agents
Decomposition Products: Yields oxides of carbon and nitrogen in a fire situation
Acute Toxicity: LD50 (oral, rat) estimated above 10,000 mg/kg for methyldopa (anhydrous); hydrate has similar profile
Skin Irritation: Mild, localized; no permanent damage expected from brief exposure
Eye Irritation: Temporary redness or discomfort may occur
Sensitization: Limited evidence of mild allergic skin reactions
Chronic Exposure: No known carcinogenicity, mutagenicity, or reproductive hazards documented in long-term studies on humans or animals at therapeutic use exposure
Inhalation: May cause coughing or mild respiratory irritation at high dust levels
Ecotoxicity: Not persistent nor bioaccumulative in aquatic environments
Aquatic Toxicity: No adverse effects observed at low concentrations in common aquatic test species
Persistence and Degradability: Readily biodegradable in activated sludge systems
Bioaccumulation Potential: Very low potential for bioaccumulation
Mobility in Soil: Moderately mobile; will partition into water phase; routine spill response limits exposure
Waste Methods: Dispose of in accordance with local, state, and federal environmental regulations for non-hazardous laboratory materials
Container Disposal: Triple rinse used containers and puncture or crush before landfill or incineration unless prohibited
Precautions for Disposal: Avoid introducing material to the environment; landfill or authorized incineration preferred
Regulatory Information: Not listed as RCRA hazardous waste
UN Number: Not regulated for transport under ADR, IMDG, ICAO, or DOT
Transport Hazard Class: None assigned
Packing Group: None
Proper Shipping Name: Pharmaceutical Ingredient, not otherwise specified
Environmental Hazards: Not considered a marine pollutant
Special Transport Precautions: Protect from excessive heat and moisture during transportation; ensure packaging prevents release of powder
Occupational Safety and Health (OSHA): Not classified as hazardous
TSCA Status: Not subject to TSCA reporting since it is a pharmaceutical active ingredient
International Inventories: Listed on applicable pharmaceutical or chemical substance lists in Europe and North America
Labeling Requirements: Follow national labeling guidelines for chemical substances in transport and workplace
REACH Status: Exempt as a medicinal product under European regulation
Status Under Other Chemical Control Laws: Exempt or approved for pharmaceutical use; compliance with GMP is crucial for supply chain management
