ENALAPRIL MALEATE, USP 25GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name ENALAPRIL MALEATE USP Supplier Information Letco Medical, LLC 1316 Commerce Drive NW Decatur, AL 35601 1 (800) 239-5288 +1 (734) 843-4693 IN CASE OF EMERGENCY: Chemtrec 1 (800) 424-9300 (24 hours) Product Synonym(s) (S)-1-(N-(1-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-L-proline (Z)-2-butenedioate salt Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Eye Irritation (Category 2) Signal Word Warning Hazard Statement(s) H318 Causes serious eye damage Pictogram(s) Precautionary Statement(s) P201 Obtain special instructions bef ore use. P260 Do not breathe dust/f ume/gas/mist/vapours/spray. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. P305+P351+P338 IF IN EYES Rinse cautiously with water f or several minutes. Remove contact lenses if present and easy to do. continue rinsing. P309+P311 IF exposed or you f eel unwell Call a POISON CENTER or doctor/physician. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name (S)-1-(N-(1-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-L-proline (Z)-2-butenedioate salt Common Name Enalapril Maleate CAS Number 76095-16-4 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice No data available. If Inhaled If inhaled, remove to fresh air. If not breathing, give artif icial respiration. If breathing is dif f icult, give oxygen In Case of Skin Contact In case of contact, immediately wash skin with soap and plenty of water. In Case of Eye Contact In case of contact, immediately f lush eyes with plenty of water f or 15 minutes at least. If Swallowed If swallowed, wash out mouth with water provided person is conscious. Call a physician. Most Important Symptoms and Effects No data available Section 5: Fire Fighting Measures Suitable Extinguishing Media Suitable extinguishing media: Water spray. Carbon dioxide, dry chemical or f oam apropiad Special Hazards Arising From the Substance/Mixture Hazardous combustion products: Emits toxic f umes under f ire. Special PPE and/or Precautions for Firefighters Use self contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Page 1 of 4 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Wear a respirator, chemical saf ety goggles, rubber boots and heavy rubber gloves Methods and Materials Used for Containment Place in a bag and hold f or waste disposal. Avoid raising dust. Ventilate area and wash the place where the product has been spilled once removed completely. Cleanup Procedures Place in a bag and hold f or waste disposal. Avoid raising dust. Ventilate area and wash the place where the product has been spilled once removed completely. Section 7: Handling and Storage Precautions for Safe Handling Avoid inhalation. Avoid contact with eyes, skin or clothing. Avoid prolonged or repeated exposure. Conditions for Safe Storage Technical measures and storage conditions: Keep tightly closed. Store in cool(storage temperature should be around 25), dry place. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Not available. Appropriate Engineering Controls Saf ety shower and eye bath. A compulsory mechanical exhaust f umes. PPE - Eye/Face Protection Chemical goggles. PPE - Skin Protection Gloves compatible chemical resistant. PPE - Body Protection Gloves compatible chemical resistant PPE - Respiratory Protection Use respirators and components tested and approved under appropriate government standards. Section 9: Physical and Chemical Properties Appearance White or of f-white powder Upper/Lower Flammability or Explosive Limits No data available Odor No data available Vapor Pressure No data available Odor Threshold No data available Vapor Density No data available pH 2.4～2.9 Relative Density No data available Melting Point/Freezing Point 143～145℃ Solubility soluble in ethanol Initial Boiling Point and Boiling Range No data available Flash Point No data available Evaporation Rate No data available Flammability (Solid, Gas) No data available Partition Coefficient No data available Auto-Ignition Temperature No data available Decomposition Temperature No data available Viscosity No data available Section 10: Stability and Reactivity Reactivity None Chemical Stability Stable. Possibility of Hazardous Reactions None Conditions to Avoid None Incompatible Materials Strong oxidizing agents. Hazardous Decomposition Products Carbon monoxide, carbon dioxide, nitrogen oxides, sulf ur oxides. Page 2 of 4 Section 11: Toxicological Information Acute Toxicity - LD50 Oral No data available Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye May cause eye irritation. Skin Corrosion/Irritation May cause skin irritation. Serious Eye Damage/Irritation May cause eye irritation. Respiratory or Skin Sensitazation No data available Germ Cell Mutagenicity No data available Carcinogenicity IARC No data available Carcinogenicity ACGIH No data available Carcinogenicity NTP No data available Carcinogenicity OSHA No data available Reproductive Toxicity No data available Specific Target Organ Toxicity - Single Exposure No data available Specific Target Organ Toxicity - Repeated Exposure No data available Aspiration Hazard No data available Section 12: Ecological Information Toxicity No data available Persistence and Degradability No data available Bio-accumulative Potential No data available Mobility in Soil No data available Other Adverse Effects No data available Section 13: Disposal Considerations Waste Treatment Methods Product Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an af terburner and scrubber. Observe all f ederal, state and local environmental protection. Waste Treatment Methods Packaging Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an af terburner and scrubber. Observe all f ederal, state and local environmental protection. Special Precautions Landfill or Incinerations No data available Other Information No data available Section 14: Transport Information UN Number Not dangerous goods. UN Proper Shipping Name N/A Transport Hazard Class(es) N/A Packaging Group N/A Environmental Hazards N/A Section 15: Regulatory Information No f urther data available. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/08/2019 16:36 Disclaimer Letco Medical, LLC believes that the above information is correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. If the product is used as a component in another product, this information may not be applicable. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED ABOVE. Letco Medical shall not be held liable for any loss or damagePage 3 of 4 resulting from handling, storage, use or from contact with the above product. Page 4 of 4
