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Product Name: Nisoldipine
Chemical Name: 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-1-methoxycarbonyl-4-(2-nitrophenyl)-dimethyl ester
CAS Number: 63675-72-9
Synonyms: Bay K 5552
Recommended Use: Pharmaceutical ingredient; antihypertensive agent
Supplier: Refer to local supplier information
Emergency Phone: Refer to local poison center or emergency services
Classification: Not classified as hazardous under GHS for normal handling in pharmaceutical environments
Health Hazards: May cause respiratory irritation, nausea, dizziness; contact with eyes or skin could result in mild irritation; ingestion can lead to hypotension and related cardiovascular effects
Environmental Hazards: Toxic to aquatic organisms, long-term adverse effects possible in aquatic environments
Label Elements: Not typically labeled for retail; precautionary statements for laboratory and industrial use
Pictograms: No standard pictogram for consumer packaging; workplace GHS irritant or environmentally hazardous symbols may apply
Signal Word: Warning
Precautionary Statements: Avoid inhalation, avoid skin and eye contact, handle with protective equipment, do not release to water sources
Main Ingredient: Nisoldipine (CAS 63675-72-9), 97–100%
Impurities: Pharmaceutical grade products may contain unspecified trace impurities below pharmacopoeial limits
Formula: C20H24N2O6
Molecular Weight: 388.42 g/mol
Other Components: None significant for safety purposes
Inhalation: Remove exposed person to fresh air; seek medical help if symptoms of dizziness or respiratory distress occur
Skin Contact: Remove contaminated clothing, wash area thoroughly with soap and water; medical attention required for persistent irritation
Eye Contact: Rinse eyes for several minutes using running water, remove contact lenses if present, seek ophthalmic assessment for pain or visual changes
Ingestion: Seek immediate medical advice; never give anything by mouth if victim is unconscious; watch for signs of low blood pressure such as fainting or weakness
Suitable Extinguishing Media: Use carbon dioxide, dry chemical, or foam; water spray recommended for larger fires
Specific Hazards: Combustion may produce hazardous fumes such as nitrogen oxides, carbon monoxide, and other toxic gases
Protective Equipment: Firefighters require self-contained breathing apparatus and full protective gear
Advice for Firefighters: Avoid inhaling fumes, cool containers with water spray from a safe distance, prevent run-off from fire control entering drains
Personal Precautions: Practice good ventilation, don suitable gloves and eye protection, prevent dust formation, avoid contact with skin and eyes
Spill Response: Gently collect spilled material without raising dust, place in clearly labeled, sealed containers for disposal
Environmental Precautions: Prevent entry into drains, surface water, or soil; notify appropriate authorities if environment contamination occurs
Cleanup Methods: Clean area with damp disposable material, thoroughly ventilate affected area after clean-up
Handling: Use local exhaust or general ventilation, wear personal protective equipment to prevent ingestion or skin contact, handle in designated areas with spill containment
Storage: Store in tightly closed containers at controlled room temperature (15–30°C), away from light, moisture, humidity, sources of ignition, and incompatible substances
Stable Storage Conditions: Maintain product integrity with desiccants in container, store separately from food and drink
Special Requirements: Restrict access to trained personnel, keep container label clearly visible
Occupational Exposure Limits: No established threshold limit values; minimize exposure using technical controls
Engineering Controls: Work with adequate ventilation or fume hood, restrict open handling to authorized facilities
Personal Protection: Chemical-resistant gloves (nitrile or latex), safety goggles or face shield, lab coat or apron, respiratory protection if dust present
Hygiene Measures: Do not eat, drink, or smoke in handling areas; wash hands and face thoroughly after usage
Environmental Controls: Prevent release to sewage, air, or water systems
Appearance: Yellow to yellow-orange crystalline powder
Odor: Odorless or faint chemical odor
Odor Threshold: Not determined
pH: Not applicable (water-insoluble solid)
Melting Point: 146–148°C
Boiling Point: Decomposes prior to boiling
Flash Point: Not flammable
Evaporation Rate: Not relevant
Solubility: Practically insoluble in water, soluble in most organic solvents (methanol, ethanol, DMSO)
Partition Coefficient (log Pow): 3.7 (estimated)
Vapor Pressure: Not significant
Density: 1.33 g/cm³ (approximate)
Explosive Properties: Not explosive
Oxidizing Properties: Not classified as an oxidizer
Chemical Stability: Stable under normal laboratory and storage conditions, light sensitive, degrades rapidly upon exposure to intense light or extreme pH
Reactivity: Not reactive under anticipated handling conditions
Incompatible Materials: Strong oxidizing agents, strong acids, bases
Hazardous Decomposition Products: Fumes of carbon monoxide, nitrogen oxides, toxic organic substances
Conditions to Avoid: Prolonged exposure to heat, open flame, sunlight, extreme acidic or alkaline conditions
Acute Toxicity: Oral LD50 in rats > 2,000 mg/kg (low categories of acute toxicity), relatively low risk from brief exposure
Routes of Exposure: Inhalation, skin, ingestion, eye contact
Symptoms of Exposure: Dizziness, nausea, headache, lowered blood pressure, skin irritation, reddening of eyes
Repeated Dose Effects: No evidence of carcinogenicity, mutagenicity, or developmental toxicity in standard animal studies at therapeutic doses
Chronic Effects: Prolonged exposure may affect liver or kidney function
Target Organs: Cardiovascular system, nervous system
Carcinogenicity Classification: Not listed by NTP, IARC, OSHA, or ACGIH as a carcinogen
Toxicity to Aquatic Life: Data on aquatic toxicity limited, structurally related compounds show toxic effects on fish and invertebrates at low concentrations
Persistence and Degradability: Not readily biodegradable, some metabolites persistent in sediment and water
Bioaccumulation Potential: Moderate potential due to lipophilicity
Mobility in Soil: Low solubility, likely to adsorb to soil particulates
Other Adverse Effects: Information suggests risk to aquatic environments, avoid waste or spills reaching waterways
Waste Handling: Manage as hazardous chemical waste under local and national regulations; avoid release to environment
Product Disposal: Incinerate in authorized, approved facility with emission controls; containers must be sterilized or rendered unusable prior to disposal
Contaminated Packaging: Rinse thoroughly, do not reuse, treat as chemical waste
Recycling: Not applicable due to pharmaceutical use and contamination risk
UN Number: Not regulated for ground, air, or sea transportation as hazardous material
Proper Shipping Name: Nisoldipine, not dangerous for transport
Hazard Class: None allocated
Packing Group: Not required
Marine Pollutant: Not regulated, but avoid release to marine environments
Special Precautions: Ship in well-sealed containers, protect from extreme temperature, prevent mechanical damage during transit
International Inventory Status: Not listed or regulated under major chemical inventories (TSCA, EINECS, DSL); prescription pharmaceutical regulated by health authorities
OSHA Status: Not classified as hazardous by OSHA Hazard Communication Standard
WHMIS Classification: Exempt as a drug product
REACH, RoHS, California Proposition 65: Not specifically subject to restrictions
Pharmaceutical Regulations: Subject to prescription and distribution controls by FDA, EMA, and local drug authorities
SARA Title III / CERCLA: Not reportable
Other National/Local Requirements: As prescribed for pharmaceuticals, manage under controlled conditions, record keeping for handling, restricted environmental release requirements
