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Product Name: Benazepril Hydrochloride
Chemical Name: (3S)-3-[[1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid monohydrochloride
Synonyms: Lotensin Hydrochloride
Molecular Formula: C24H28N2O5·HCl
Molecular Weight: 460.95 g/mol
CAS Number: 86541-75-5
Recommended Use: Antihypertensive, pharmaceutical ingredient
Supplier: Pharmaceutical manufacturers, distributors
Contact Information: Emergency and technical contacts as listed on label or packaging
GHS Classification: Acute oral toxicity (Category 4), Eye irritation (Category 2A), Specific target organ toxicity – single exposure (Category 3)
Signal Word: Warning
Hazard Statements: Harmful if swallowed, Causes serious eye irritation, May cause respiratory irritation
Pictograms: Exclamation mark symbol
Precautionary Statements: Avoid inhalation, wash hands thoroughly after handling, use only in well-ventilated areas, wear protective gloves and eye protection
Potential Health Effects: Inhalation can lead to cough, sore throat; skin contact may cause irritation or redness; ingestion may result in gastrointestinal symptoms or systemic toxicity.
Chemical Identity: Benazepril Hydrochloride
Purity: ≥ 98% (as supplied in pharmaceutical manufacturing)
Impurities: Trace related substances as specified by regulatory monographs
Excipient Presence: Pure substance contains only active material, no added fillers or binders for bulk, finished tablets may contain microcrystalline cellulose, lactose, etc.
Inhalation: Move person to fresh air, keep comfortable, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, wash exposed area with plenty of water and mild soap, consult healthcare provider if irritation develops
Eye Contact: Rinse eyes cautiously with water for several minutes, remove contact lenses if present, continue rinsing, obtain medical attention
Ingestion: Rinse mouth with water, never give anything by mouth to an unconscious person, get immediate medical help
Most Important Symptoms: Nausea, cough, headache, eye irritation, respiratory issues can occur after exposure
Advice to Physician: Treat symptomatically, monitor blood pressure and renal function
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray for small fires
Unsuitable Media: Direct jet of water can disperse powder
Specific Hazards: Combustion forms hazardous fumes, including oxides of nitrogen and carbon, hydrochloric acid vapors
Protective Equipment: Firefighters should wear self-contained breathing apparatus, full protective gear
Special Precautions: Avoid inhaling combustion gases, use water spray to cool containers exposed to fire
Personal Precautions: Use personal protective equipment, avoid breathing dust, ensure adequate ventilation
Environmental Precautions: Prevent further leakage or spillage if safe, do not allow material to enter drains or surface water
Methods for Cleaning Up: Collect powder by mechanical means, avoid creating airborne dust, sweep or scoop into labeled waste bags for disposal, wipe area with damp absorbent material for final clean
Handling: Use local exhaust ventilation, minimize dust production, keep away from food and beverages, wash hands after use, avoid contact with skin and eyes
Storage: Store tightly closed in original container in cool, dry, well-ventilated area, temperature below 30°C, protect from moisture and direct sunlight, segregate from incompatible substances such as strong oxidizers
Exposure Limits: No occupational exposure limit values available for benazepril hydrochloride; handle as a potential irritant
Engineering Controls: Use process enclosures or ventilated hoods in industrial settings
Personal Protective Equipment:
Eye Protection: Safety glasses or chemical splash goggles
Skin Protection: Laboratory coats, long sleeves, gloves resistant to chemicals (nitrile recommended)
Respiratory Protection: Use NIOSH-approved respirator or dust mask in areas with high powder concentration
Hygiene Measures: Do not eat, drink, or smoke during handling, wash thoroughly before breaks and after work
Appearance: White to off-white crystalline powder
Odor: Odorless or faint odor
Odor Threshold: Not determined
pH: Approximately 2.5 – 3.5 (1% aqueous solution)
Melting Point: 186°C – 190°C
Boiling Point: Not applicable (decomposes)
Flash Point: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Negligible
Solubility: Freely soluble in water, sparingly soluble in methanol, insoluble in ether and chloroform
Partition Coefficient (log Kow): Not determined
Autoignition Temperature: Not determined
Explosive Properties: Not classified as explosive
Oxidizing Properties: Not classified as oxidizer
Density: Not determined
Chemical Stability: Stable under normal temperatures and recommended storage conditions
Reactivity: Not highly reactive at room temperature
Hazardous Reactions: Contact with strong oxidizing agents may cause reaction
Conditions to Avoid: Heat, moisture, direct light, incompatible chemicals
Hazardous Decomposition Products: May form carbon monoxide, carbon dioxide, hydrochloric acid, nitrogen oxides on combustion or decomposition
Routes of Entry: Inhalation, ingestion, dermal and ocular contact
Acute Toxicity: Oral LD50 (rat): >500 mg/kg; considered harmful if swallowed in large amounts
Chronic Toxicity: Animal studies show possible changes in blood pressure and kidney function with long exposure
Carcinogenicity: No data indicating carcinogenicity in humans
Reproductive Toxicity: Animal data show potential risk to fetus at high doses; not recommended in pregnancy
Symptom Information: May cause headache, dizziness, cough, nausea, and hypersensitivity reactions
Other Information: Occupational exposure in workplaces should be minimized due to potential systemic effects
Environmental Impact: Not readily biodegradable, persistent in soil and water
Ecotoxicity: Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment
Bioaccumulative Potential: Potential for low to moderate bioaccumulation due to structure
Mobility in Soil: Moderate mobility expected; water solubility may lead to some leaching
Other Adverse Effects: No information suggesting significant ozone depletion or global warming effect
Waste Handling: Collect in tightly closed containers, store for disposal according to local, national, and international regulations
Treatment: Incinerate in permitted facility, do not discharge into sewage systems or natural waters
Container Disposal: Rinse empty containers with water, dispose of in landfill authorized for pharmaceutical waste
Precautions: Avoid unprotected contact with waste material, label all containers with chemical identity and hazard information
UN Number: Not regulated for transport under UN, ADR, IATA, or IMDG
Proper Shipping Name: Not classified as hazardous for transport
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Special Precautions: Prevent exposure to moisture, avoid contact with incompatible chemicals during shipment
US TSCA: Not listed
EU REACH: Registration required for quantities above 1 tonne per year
IARC, NTP, OSHA Carcinogen Status: Not listed as a carcinogen
OSHA HazCom: Hazardous chemical as per OSHA Hazard Communication Standard
Other Regulations: Follow specific workplace safety regulations and comply with FDA/EMA rules for GMP
Label Elements: Required identification of chemical, hazards, and safe handling on product label
Inventory Status: Not listed on major chemical inventories unless intended for research or manufacturing use
