© 2026 Sinochem Nanjing Corporation,
All Right Reserved
Product Name: Enalapril Maleate
Chemical Name: (S)-1-[N-(1-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl]-L-proline, (Z)-2-butenedioate salt
CAS Number: 76095-16-4
Molecular Formula: C20H28N2O5·C4H4O4
Recommended Use: Antihypertensive agent, ACE inhibitor
Manufacturer: Pharmaceutical companies manufacturing prescription drugs
Emergency Telephone: Refer to local poison control or medical emergency hotlines
GHS Classification: Not classified as hazardous under GHS; precaution recommended for handling pharmaceuticals
Physical Hazards: None reported for solid form
Health Hazards: May cause allergic reactions in sensitive individuals, inhalation and skin contact risks for pharmaceutical workers, low acute toxicity in general population at therapeutic doses
Environmental Hazards: Not considered highly hazardous, but avoid uncontrolled release into environment
Signal Word: None required
Pictograms: Not applicable
Precautionary Statements: Avoid dust generation, exposure to eyes and skin, inhalation of powder, ingesting large quantities outside medical supervision
Substance: Enalapril Maleate
Concentration: Pharmaceutical grade, varies by dosage form, usually 2.5 mg, 5 mg, 10 mg, and 20 mg tablets
Impurities: Pharmaceutical impurities trace, not listed in bulk product
Stabilizers/Excipients: In tablet forms: lactose, microcrystalline cellulose, starch, magnesium stearate (may vary by manufacturer)
Synonyms: Vasotec, Renitec
Inhalation: Move to fresh air, seek medical advice if symptoms persist, provide oxygen if breathing gets difficult
Skin Contact: Wash skin promptly with mild soap and water, remove contaminated clothing, seek medical attention for irritation
Eye Contact: Rinse eyes immediately with plenty of water, keep eyelids open, get medical help if irritation continues
Ingestion: Rinse mouth, do not induce vomiting, seek prompt medical advice, monitor for symptoms of overdose like low blood pressure or dizziness
Acute Symptoms: Hypotension, cough, headache, signs of hypersensitivity
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray
Unsuitable Media: High-pressure water jet may scatter powder
Hazards: Product may decompose forming toxic fumes of carbon oxides, nitrogen oxides
Protective Equipment: Firefighters should use self-contained breathing apparatus and protective clothing
Advice for Firefighters: Avoid inhalation of smoke or fumes, cool containers with water if exposed to fire, move undamaged containers from hazard area
Personal Precautions: Wear gloves, safety goggles, dust mask when handling bulk powder
Environmental Precautions: Prevent further leakage or spillage if safe to do so, avoid contamination of waterways
Cleanup Methods: Sweep up without raising dust using non-sparking tools, collect in appropriate waste containers for disposal, ventilate area after cleaning
Spill Size Consideration: Use more containment for large or bulk quantities, wipe clean small spills carefully
Handling: Practice good industrial hygiene with pharmaceutical substances, wash hands thoroughly after handling, avoid generating dust or aerosols, use adequate ventilation
Storage Conditions: Keep container tightly closed, store in a cool, dry and well-ventilated area, protect from light and moisture, segregate from incompatible substances including strong oxidizers
Incompatible Materials: Strong acids, bases, and oxidizing agents may cause degradation
Special Storage: Store below 25°C for long-term stability, use original packaging to prevent contamination
Packaging: Use moisture-proof and air-tight containers
Occupational Exposure Limit: Not established for enalapril maleate specifically, treat as a potent pharmaceutical with caution
Engineering Controls: Use process enclosures, local exhaust ventilation or other engineering controls to control airborne dust
Personal Protective Equipment: Safety goggles, chemical-resistant gloves, laboratory coat recommended for handling bulk substance
Respiratory Protection: NIOSH-approved dust mask or respirator if dust generation is likely
Hygiene: Avoid eating, drinking, or smoking while handling product; thorough hand-washing after use essential
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: Not applicable in solid form
Melting Point: Close to 143–144°C (decomposition may occur above this point)
Boiling Point: Not determined (decomposes before boiling)
Solubility: Freely soluble in water, methanol, sparingly soluble in ethanol, practically insoluble in acetone and in ethyl acetate
Partition Coefficient (Log P): Approximately 1.2
Vapor Pressure: Not applicable due to very low volatility
Density: Approximately 1.25 g/cm³
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Explosive Properties: Not explosive
Other Information: Stable under standard conditions if kept dry and protected from heat and light
Chemical Stability: Stable under recommended storage conditions, sensitive to moisture
Decomposition: Decomposition at high temperature may form carbon monoxide, carbon dioxide, nitrogen oxides
Reactivity: No hazardous reactions if stored and handled properly
Hazardous Polymerization: Will not occur
Conditions to Avoid: Exposure to excessive heat, moisture, open flames, and strong oxidants
Incompatible Materials: Strong acids, strong bases, powerful oxidizing agents
Acute Toxicity: LD50 oral (rat) > 2000 mg/kg; low acute toxicity at therapeutic doses
Potential Health Effects: Overexposure may lower blood pressure, cause dizziness, headache, allergic reactions including rash and swelling, persistent dry cough
Sensitization: Some individuals may develop hypersensitivity reactions
Chronic Toxicity: No evidence of carcinogenicity or mutagenicity in animal studies; long-term safety established in clinical settings for prescribed uses
Reproductive Effects: Contraindicated in pregnancy due to risk of fetal injury
Aspiration Hazard: Not applicable
Ecotoxicity: No significant acute aquatic toxicity expected at normal environmental concentrations, possible concern at high and sustained discharges
Persistence and Degradability: Partial biodegradation in sewage treatment plants, not persistent in treated systems
Bioaccumulation: Likely to have low bioaccumulation potential based on physical-chemical properties
Mobility in Soil: Readily dissolved and mobile in aqueous systems, but expected to degrade gradually
Other Adverse Effects: Avoid release into waterways, sewers or soil in large amounts as a precaution
Waste Disposal Methods: Dispose of in accordance with local, regional and national regulations for pharmaceuticals; do not discharge into drains, water courses or onto the ground
Handling of Waste: Use dedicated waste containers for laboratory or manufacturing waste, label clearly, protect from unauthorized access
Disposal of Packaging: Clean and recycle or dispose of according to applicable recycling standards or hazardous waste procedures
Special Precautions: Incineration in approved facilities recommended for bulk wastes
UN Number: Not regulated as a hazardous material for transport
Proper Shipping Name: Enalapril Maleate
Transport Hazard Class: Not classified
Packing Group: Not assigned
Marine Pollutant: No
Special Precautions: Protect from moisture, avoid rough handling, keep containers intact during transport
Labeling: Standard labeling for pharmaceutical products
US Regulations: Not listed as a hazardous substance under CERCLA, SARA, TSCA
OSHA Classification: Not classified as hazardous under OSHA regulation
EU Regulations: Exempt as a medicinal product under REACH Annex V
Canada WHMIS: Not controlled
Other Local Regulations: Comply with regulations regarding handling of pharmaceutical agents, environmental protection, workplace exposure
Labelling Requirements: Comply with applicable legislation for pharmaceuticals and hazardous substances during manufacturing and transport
