© 2026 Sinochem Nanjing Corporation,
All Right Reserved
Product Name: Ramipril
Chemical Name: (2S,3aS,6aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid, 1-ethyl ester
CAS Number: 87333-19-5
Molecular Formula: C23H32N2O5
Molecular Weight: 416.51 g/mol
Synonyms: Tritace, Altace, Delix
Manufacturer: Various pharmaceutical suppliers and manufacturers, commonly distributed worldwide
Intended Use: ACE inhibitor prescribed for hypertension, heart failure, and cardiovascular risk reduction
Emergency Contact: Local poison control center or medical professional
Packaging: Blister packs, bottles, or bulk containers for pharmaceutical formulations
Relevant Identifiers: Provided on supplier or manufacturer labels, includes batch number and expiry date for traceability
Hazard Classification: Not classified as hazardous under GHS for most end users, but bulk powder presents dust irritant risk
Routes of Exposure: Inhalation, eye contact, skin contact, ingestion
Acute Health Hazards: May cause irritation to respiratory tract, eyes, and skin; ingestion can cause hypotension, dizziness, headache
Chronic Health Hazards: Repeated exposure, especially in pharmaceutical production, may affect blood pressure regulation
Target Organs: Cardiovascular system, kidneys
Label Elements: Avoid inhalation, use protective equipment, handle with care
Signal Word: None required for finished tablets; “Warning” for bulk active ingredient
Pictograms: Eye and respiratory tract warning for dust; consult supplier data
Environmental Hazards: Limited data, possible aquatic toxicity not excluded for large spills
Active Ingredient: Ramipril 100% in bulk API, lower in formulated tablets/capsules
Impurities: ≤0.1% related substances (manufacturing origin dependent)
Excipients: Tablet or capsule formulations also contain microcrystalline cellulose, sodium starch glycolate, magnesium stearate, lactose monohydrate, coloring agents (not in bulk API)
Formulation: Pure powder (API), compressed tablets, capsules
Allergenic Components: Possible presence of lactose in tablets (not in API powder)
Inhalation: Move individual to fresh air, monitor for difficulty breathing, seek medical help for persistent symptoms
Skin Contact: Wash with water and soap for several minutes, remove contaminated clothing
Eye Contact: Rinse eyes with gentle stream of water for at least 15 minutes, get medical attention if irritation continues
Ingestion: Rinse mouth thoroughly, seek immediate medical advice, monitor for dizziness, severe low blood pressure, or shock
Notes for Medical Personnel: Symptomatic and supportive care, monitor blood pressure and fluid/electrolyte status, avoid emesis unless advised by poison control
Suitable Extinguishing Media: Dry chemical, CO2, water spray, foam
Unsuitable Extinguishing Media: High pressure water jet may disperse dust
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides
Protective Equipment for Firefighters: Self-contained breathing apparatus, full protective clothing
Special Procedures: Control runoff, avoid exposure to combustion products, ventilate area after extinguishing
Explosion Hazards: Dust clouds of bulk Ramipril powder may ignite under specific conditions
Personal Precautions: Evacuate unnecessary personnel, wear dust-proof mask, gloves, goggles
Spill Cleanup: Avoid raising dust, collect spilled powder with damp disposable towel or HEPA vacuum
Environmental Precautions: Prevent large quantities from entering drains or watercourses
Decontamination: Clean area with water and detergent, ventilate until all residues are removed
Disposal: Use licensed waste disposal contractor, label material as pharmaceutical waste
Handling: Handle in well-ventilated area, avoid breathing dust, minimize contact with skin and eyes
Protective Measures: Use local exhaust or containment for bulk operations, wear gloves and protective clothing
Storage Conditions: Store in tightly closed container, away from moisture, direct sunlight, incompatible substances
Temperature Range: Recommended at controlled room temperature (15–30°C)
Incompatible Materials: Strong oxidizers, acids, bases
Storage Life: Follow manufacturer-provided expiry date, monitor for changes in color or odor
Occupational Exposure Limits: None assigned for Ramipril; use best practice in pharmaceutical production and compounding
Engineering Controls: Ventilation systems, closed-handling processes, or local exhaust for powder
Personal Protective Equipment: Disposable gloves (nitrile preferred), lab coats or disposable coveralls, safety glasses or face shields
Respiratory Protection: Dust mask or N95 respirator for powder handling
Hygiene Measures: Wash hands thoroughly after handling, avoid eating or drinking in work area
Environmental Controls: Do not flush large amounts into public drainage systems
Appearance: White to off-white crystalline powder (API); characteristic of finished tablets with coating
Odor: Faint, may have slight characteristic pharmaceutical smell
Odor Threshold: Not determined
pH: 2–3 for a 1% solution
Melting Point: 109–112°C
Boiling Point: Decomposes before boiling
Flash Point: Not applicable (solid)
Flammability: Powder can form explosive mixture with air at high concentrations
Vapor Pressure: Negligible
Solubility: Slightly soluble in water, soluble in methanol and ethanol, sparingly soluble in chloroform
Partition Coefficient (Log P): 2.2–2.4
Viscosity: Not applicable
Evaporation Rate: Not applicable
Chemical Stability: Stable under prescribed storage conditions, sensitive to moisture and light
Reactivity: Normally unreactive under recommended conditions
Hazardous Reactions: May react with strong oxidizing agents
Polymerization: Will not polymerize
Conditions to Avoid: Humidity, direct sunlight, heat, open flames
Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides under fire conditions
Acute Toxicity: Low oral median lethal dose (LD50) in rodent models, clinical effects noted at therapeutic levels in humans
Chronic Effects: Prolonged exposure could lower blood pressure, affect kidney function; impacts more pronounced for workers handling uncoated bulk powder
Irritation: May cause mild skin, eye, or respiratory irritation, especially in sensitive individuals or pre-existing conditions
Sensitization: No evidence of allergic sensitization in users, rare case reports in industrial settings
Mutagenicity: No mutagenic effects noted in standard assays
Carcinogenicity: No evidence for carcinogenicity in human studies
Other Information: Risk of fetal toxicity in pregnancy, avoid unprotected handling by pregnant workers
Ecotoxicity: Data limited; structurally similar compounds have shown low toxicity to aquatic organisms at environmental concentrations
Persistence and Degradability: Degrades slowly in water and soil
Bioaccumulative Potential: Not expected to significantly bioaccumulate
Mobility in Soil: Moderate mobility based on solubility and structure
Other Adverse Effects: Cumulative pharmaceutical impact may be significant with improper disposal or industrial discharge
Waste Treatment Methods: Dispose through authorized pharmaceutical waste handlers, comply with local/regional regulations
Container Disposal: Triple rinse, puncture, or crush containers before landfilling or incineration
Environmental Precautions: Prevent entry to water systems; large-scale disposal requires environmental safeguards
Instructions for Users: Return expired or unused medicine to pharmacy collection points wherever possible
UN Number: Not regulated for transport in most countries
Proper Shipping Name: Ramipril (Rx medicine), not classified as dangerous goods
Hazard Class: Not assigned
Packing Group: Not applicable
Special Precautions: Protect from moisture, physical damage, and heat during shipment
Label Requirements: Pharmaceutical or laboratory labeling, include batch and handling instructions as necessary
Regulatory Status: Prescription-only medicine in most jurisdictions
Occupational Safety: Not specifically regulated as a hazardous substance; apply general safety for pharmaceutical active ingredients
Labeling Requirements: Comply with national and international pharmaceutical labeling laws, including risk phrases where applicable
Inventory Listings: Registered with national pharmaceutical regulatory agencies
Additional Information: Subject to controls under Good Manufacturing Practice (GMP) and pharmacovigilance standards
Emergency Planning: Facilities handling >25 kg should have documented emergency and exposure response protocols
