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Product Name: Amlodipine Besylate
Synonyms: Amlodipine benzene sulfonate, Norvasc, Amlong, Istin
Chemical Family: Calcium channel blocker
Molecular Formula: C20H25ClN2O5·C6H6O3S
Molecular Weight: 567.1 g/mol
CAS Number: 111470-99-6
Intended Use: Pharmaceutical ingredient for blood pressure control
Manufacturer: Major pharmaceutical companies; also produced by various generic medicine manufacturers
Contact for Information: Reach the manufacturing site address on packaging or safety insert
Emergency Phone Number: Refer to packaging or local emergency services
Hazard Class: Not classified as hazardous under OSHA Hazard Communication Standard
Physical Risks: Dust may irritate respiratory tract; powders can exacerbate asthma or other lung conditions
Health Effects: Toxic if ingested in large quantities; headache, flushing, palpitations, hypotension, edema possible
Eye Contact: May cause mild to moderate irritation; pain and redness have occurred with direct exposure
Skin Contact: Minor irritation may develop on sensitive skin from fine dust
Inhalation: Breathing dust can irritate mucous membranes and throat; higher doses might lead to more serious effects
Environment: Small-scale lab accidents unlikely to harm the environment, but large spills should not reach waterways
Signal Word: WARNING
Precautionary Statements: Avoid breathing dust, avoid contact with eyes and skin, wash hands after handling
Substance: Amlodipine Besylate pure active pharmaceutical ingredient
Concentration: 100% (for pure substance); tableted or compounded forms will contain fillers and stabilizers
Other Ingredients: None in raw API
Impurities: Residual solvents and synthesis by-products controlled to <0.1% per pharmacopoeial standards
Decomposition Products: None under ambient conditions
Structure: Contains both organic and inorganic groups with a sulfonate counterion
Molecular Characteristics: White or almost white crystalline powder, odorless or faintly aromatic
General Advice: Move exposed person to fresh air; seek medical advice for acute symptoms
If Inhaled: Move to area with fresh air; keep person at rest; seek medical help if breathing becomes difficult
If Swallowed: Do not induce vomiting unless instructed by a medical professional; rinse mouth; provide water only if person is fully conscious; call medical services
If on Skin: Remove contaminated clothing; wash affected area thoroughly with soap and water for at least 15 minutes; seek attention if irritation persists
If in Eyes: Flush gently but thoroughly with clean water for at least 15 minutes, holding eyelids open; seek attention for persistent pain, redness, or visual changes
Immediate Medical Attention: A physician should evaluate all persons exposed to large amounts or displaying acute symptoms
Symptoms Requiring Treatment: Hypotension, allergic reactions, trouble breathing
Suitable Extinguishing Media: Use dry powder, carbon dioxide, foam, or water spray
Unsuitable Extinguishing Media: Direct jet of water could spread dust and powder
Fire Hazards: Does not readily ignite, but organic dust can pose a combustion hazard in enclosed spaces
Hazardous Combustion Products: May emit carbon oxides, nitrogen oxides, sulfur oxides, hydrogen chloride fumes under fire conditions
Special Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Explosion Hazards: Fine dust can form explosive mixtures with air; take care to avoid dispersing powder
Personal Precautions: Wear protective equipment to avoid skin and eye contact, prevent dust inhalation
Environmental Precautions: Prevent product from entering drains, surface water, or soil directly
Containment Methods: Collect spilled material using scoop or vacuum equipped with HEPA filter; minimize powder clouds
Clean-Up Procedures: Wipe surface with wet sponges or cloths after collection; decontaminate area thoroughly
Reporting: Notify appropriate authorities if large amounts released into environment
Disposal: Place in closed, labeled container for appropriate waste disposal following regulations
Handling: Use only in well-ventilated areas or fume hood; avoid creating dust; do not breathe powder
Protection: Wear gloves, lab coat, and eye protection; wash hands after use; do not eat, drink, or smoke during use
Storage Conditions: Store in original container in a cool, dry, well-ventilated area away from light and incompatible materials
Temperature Range: Store below 30°C (86°F); avoid exposure to excessive heat or moisture
Incompatibilities: Avoid strong oxidizers, strong acids, and bases
Shelf Life: Check manufacturer’s expiration date for stability guarantee
Special Advice: Keep containers tightly closed and out of reach of unauthorized personnel
Occupational Exposure Limits: No established OSHA or ACGIH limits; minimize exposure as a pharmaceutical compound
Engineering Controls: Use ventilated enclosures or fume hoods; avoid open handling of powders
Respiratory Protection: Use a NIOSH-approved respirator suitable for pharmaceutical dust if handling large quantities or if ventilation is inadequate
Eye Protection: Chemical safety goggles or safety glasses with side shields
Skin Protection: Chemical-resistant gloves such as nitrile; lab coat or gown
Hygiene Measures: Wash hands and forearms thoroughly after handling; remove contaminated clothing
Appearance: White or almost white crystalline powder
Odor: Odorless or faintly aromatic
Melting Point: Approximately 196°C (sensitive to decomposition)
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Soluble in methanol, sparingly soluble in water, slightly soluble in ethanol
pH (1% solution): 5.5–7.5
Vapor Pressure: Negligible
Density: Approximately 1.14 g/cm³
Partition Coefficient (log P): 2.4–2.6
Reactivity: Stable in typical pharmaceutical preparations at room temperature
Stability: Chemically stable under ambient laboratory conditions
Decomposition: May slowly decompose under improper storage; rapid decomposition by strong heat
Hazardous Reactions: No hazardous polymerization reported
Incompatible Materials: Strong oxidizing agents, strong acids, bases, moisture
Conditions to Avoid: High humidity, high temperatures, light exposure
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride, sulfur oxides
Acute Toxicity: LD50 (oral, rat): 40 mg/kg
Chronic Exposure: Long-term overexposure may affect blood pressure, and heart function
Likely Routes of Exposure: Skin contact, eye contact, inhalation, ingestion
Symptoms: Headache, dizziness, nausea, edema, flushing, hypotension, tachycardia possible at significant exposures
Allergic Reactions: Rare allergic reactions including rash and itching have been reported in sensitive individuals
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, or OSHA
Other Data: Animal studies show minor reproductive toxicity at very high doses; normal clinical doses considered safe under medical supervision
Ecotoxicity: Toxic at high concentrations to aquatic life; exact LC50 not determined for Amlodipine Besylate
Persistence and Degradability: Not rapidly biodegradable; may persist in surface water
Bioaccumulation Potential: Predicted to have low bioaccumulation based on molecular size and log P
Mobility: Moderate mobility in soils possible due to water solubility
Other Effects: Pharmaceutical residues can affect aquatic organisms even at low concentrations; prudent disposal practices reduce risk
Waste Disposal Methods: Dispose of in accordance with local, state, and federal regulations for pharmaceutical waste
Environmental Precautions: Prevent contamination of soil, water, and drains
Incineration: Incineration in an approved facility recommended for large-scale disposal
Unused Product: Return unused material to manufacturer or authorized hazardous waste handler
UN Number: Not assigned
Proper Shipping Name: Not regulated for transportation as a hazardous material
Transport Hazard Class: Not classified
Packing Group: Not assigned
Label Requirements: General pharmaceutical labeling
Environmental Hazards: Not a marine pollutant; avoid large releases
Special Precautions: Do not transport with food or animal feed; protect from moisture, direct sunlight, temperature extremes
TSCA Status: Not listed for non-industrial use
RCRA Status: Not a listed hazardous waste, but manage according to pharmaceutical waste regulations
SARA Title III: Does not contain any components subject to SARA reporting
California Proposition 65: Not listed
OSHA: Not regulated as a hazardous chemical
Other Relevant Regulations: Subject to pharmaceutical regulations in finished dose form; API handled as chemical substance in workplace
