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Name: Nifedipine
Synonyms: Adalat, Procardia, 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridine dicarboxylic acid dimethyl ester
CAS Number: 21829-25-4
Molecular Formula: C17H18N2O6
Recommended Use: Pharmaceutical, calcium channel blocker for hypertension and angina
Manufacturer: Contact information for supplier or manufacturer as required
Emergency Phone: Manufacturer’s Emergency Contact Number
Product Description: Yellow crystalline powder
Classification: Acute toxicity (oral), Skin irritation, Eye damage, Specific target organ toxicity
Signal Word: Warning
Hazard Statements: Harmful if swallowed, causes skin and eye irritation, may affect organs through prolonged exposure
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, use only outdoors or in a well-ventilated area
Potential Health Effects: May cause blood pressure drop, dizziness, allergic reactions, gastrointestinal irritation
Environmental Hazard Elements: Toxic to aquatic organisms
Chemical Identity: Nifedipine
Concentration: 100% active pharmaceutical ingredient in raw form
Impurities: No significant impurities relevant for classification
Additives: None in pure substance
Stabilizers: None required for bulk storage
Inhalation: Move to fresh air, keep patient at rest, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, wash skin gently with soap and water, consult physician if irritation develops
Eye Contact: Rinse thoroughly with plenty of water for at least 15 minutes, lift eyelids occasionally, seek immediate medical care
Ingestion: Rinse mouth, do not induce vomiting, drink water if conscious, seek medical advice urgently
Symptoms & Effects: Dizziness, low blood pressure, nausea, skin or eye irritation
Medical Attention: Medical supervision may be required in severe exposures or allergic reactions
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray
Unsuitable Extinguishing Media: Strong water jets may disperse powder
Hazardous Combustion Products: Oxides of carbon, nitrogen oxides, irritating fumes
Protective Equipment: Full protective gear and self-contained breathing apparatus for fire fighters
Fire Hazards: Product can emit toxic fumes when burned, dust can present a potential explosion risk
Advice for Firefighters: Remove containers from change of fire if it can be done safely, use water spray to cool containers
Personal Precautions: Wear appropriate protective equipment including gloves, goggles, and an approved dust mask
Environmental Precautions: Prevent entry into water systems, sewers, or soil
Clean-up Methods: Sweep up without raising dust, use a HEPA vacuum or dampen to avoid airborne particulates, place in suitable closed container for disposal
Decontamination: Wash area with soap and water after material has been picked up
Reference to Other Sections: Use proper personal protection as listed in Section on Exposure Controls/Personal Protection
Handling: Avoid contact with skin, eyes or clothing, avoid inhalation of dust or vapor, maintain good industrial hygiene, work in a well-ventilated area, wash hands before breaks and at end of workday
Storage: Store in a tightly closed container in a cool, dry, well-ventilated place, away from incompatible materials like strong oxidizers and sunlight, protect from moisture
Incompatibilities: Strong oxidizing agents, direct sunlight
Storage Temperature: Store at room temperature, preferably between 15°C - 30°C
Occupational Exposure Limits: No established OSHA or ACGIH limits; handle as a potentially hazardous pharmaceutical
Engineering Controls: Local exhaust ventilation, containment technology for weighing and mixing
Eye Protection: Safety glasses with side-shields or goggles
Skin Protection: Chemical-resistant gloves, protective clothing such as lab coat
Respiratory Protection: NIOSH-approved dust respirator in absence of adequate ventilation
Hygiene Measures: Wash hands and face before eating, drinking, or smoking; change dirty clothing promptly
Environmental Controls: Prevent release to environment with proper process enclosures and waste disposal
Form: Crystalline powder
Color: Yellow
Odor: Odorless
Melting Point: 172-174°C
Boiling Point: Not relevant as decomposes
Solubility: Slightly soluble in water, soluble in organic solvents like ethanol and chloroform
Vapor Pressure: Not measurable under ambient conditions
pH: Not applicable
Partition coefficient (log Pow): 2.2-2.8
Flash Point: Not determined (expected non-volatile)
Autoignition Temperature: Not available
Chemical Stability: Stable under normal conditions
Reactivity: Unreactive with most substances at room temperature
Hazardous Reactions: May react with strong oxidizing agents, decomposes at elevated temperatures
Conditions to Avoid: Direct sunlight, excessive heat, moisture
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, other toxic fumes
Incompatible Materials: Strong acids and oxidizers
Acute Toxicity: LD50 oral in rats approximately 500 mg/kg
Skin Corrosion/Irritation: May cause irritation upon contact
Serious Eye Damage/Irritation: Dust and powder can irritate eyes
Respiratory Sensitization: Dust inhalation may cause respiratory irritation
Skin Sensitization: Not classified as sensitizer but may cause irritation
Genotoxicity: Negative in most bacterial tests, not considered mutagenic
Repeated Dose Toxicity: Prolonged or repeated exposure can affect cardiovascular system
Carcinogenicity: Not classified as carcinogenic by IARC, OSHA, or NTP
Reproductive Toxicity: High doses tested in animals showed potential embryotoxicity
Aquatic Toxicity: Toxic to aquatic life, may cause long-term adverse effects in aquatic environments
Persistence and Degradability: Not readily biodegradable, tends to persist in the environment
Bioaccumulative Potential: Moderate potential for bioaccumulation (log Pow 2.2-2.8)
Mobility in Soil: Low mobility based on partition coefficient
Other Adverse Effects: Avoid release to environment, impacts most likely with large accidental spills
Waste Disposal Methods: Incinerate in an approved facility or send to licensed hazardous waste disposal contractor, follow local, regional, and national regulations
Contaminated Packaging: Rinse thoroughly, dispose of in accordance with official regulations
Avoidance: Do not release product or contaminated rinse water into sewers or waterways
Special Precautions: Handle contaminated waste with gloves and appropriate PPE; label all containers clearly
UN Number: Not assigned for pharmaceutical raw powder
UN Proper Shipping Name: Not regulated in most jurisdictions for land, air, or sea transport
Transport Hazard Class: Not classified as dangerous for transport
Packing Group: Not assigned
Environmental Hazards: May present hazard to environment if released in significant amounts
Special Precautions: Package securely to prevent rupture, follow organizational SOPs for handling and shipment
TSCA Status: Not listed as chemical substance due to pharmaceutical application
OSHA Hazard Communication: Considered hazardous chemical under OSHA 29 CFR 1910.1200
SARA Title III: Not subject to reporting requirements
California Proposition 65: Not listed as carcinogen or reproductive toxin
EU Regulations: Complies with REACH and CLP, not classified for supply as hazardous in small quantities for medicinal use
Other International Regulations: Subject to individual country pharmaceutical and workplace safety laws
