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Material Safety Data Sheet – Nitrendipine

Identification

Chemical Name: Nitrendipine
CAS Number: 39562-70-4
Synonyms: Baypress, Cardif, Unipress
Molecular Formula: C18H20N2O6
Molecular Weight: 360.36 g/mol
Recommended Use: Antihypertensive, pharmaceutical research and development
Supplier: Contact details available on request
Emergency Contact: Refer to local hazardous material response or Poison Control

Hazard Identification

Classification: Hazardous under OSHA Hazard Communication Standard (29 CFR 1910.1200); Acute Toxicity Oral Category 4; Eye Irritant Category 2
GHS Label Elements: Exclamation mark symbol
Signal Word: Warning
Hazard Statements: Harmful if swallowed. Causes serious eye irritation. May cause respiratory irritation. Risk of skin irritation.
Precautionary Statements: Avoid breathing dust. Wash hands thoroughly after handling. Wear protective gloves and eye/face protection. Do not eat, drink, or smoke when using this product. If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing.
Pictograms: Exclamation mark

Composition / Information on Ingredients

Substance: Nitrendipine
Concentration: 98–100%
Impurities: Related organic impurities < 2% (as per USP, EP standards)
Chemical Characterization: Organic compound, dihydropyridine structure
Other Components: No additional hazardous ingredients present within accepted limits

First Aid Measures

Inhalation: Move exposed person to fresh air. Provide oxygen if breathing is difficult. Call a physician if symptoms persist (coughing, shortness of breath, headache).
Skin Contact: Take off contaminated clothing. Wash exposed skin thoroughly with soap and water. Seek medical advice if irritation continues.
Eye Contact: Rinse eyes gently but thoroughly with water for at least 15 minutes, holding eyelids open. Remove contact lenses. Consult ophthalmologist if irritation, redness, or pain persists.
Ingestion: Rinse mouth with water. Do not induce vomiting unless instructed by medical personnel. Give water to drink if conscious. Call medical assistance or Poison Control center.
Acute and Delayed Symptoms: May cause eye, skin, respiratory, and gastrointestinal irritation, drowsiness, hypotension

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, foam, dry chemical powder, or carbon dioxide.
Unsuitable Media: Direct water jets can spread powder.
Hazards from Combustion: Emits toxic fumes of nitric oxide, carbon monoxide, carbon dioxide, and nitrogen oxides on burning.
Advice for Firefighters: Use self-contained breathing apparatus and protective clothing. Keep containers cool with water spray. Prevent runoff into sewers or waterways. Stand upwind from fire site.
Special Procedures: Evacuate area. Avoid inhalation of fumes. Collect extinguishing water, prevent entry into water bodies.

Accidental Release Measures

Personal Precautions: Wear appropriate protective equipment including gloves, long-sleeved clothing, safety goggles, and NIOSH-approved respirator.
Environmental Precautions: Prevent further leakage or spillage if safe to do so. Do not let product enter drains, surface water, or soil.
Methods for Cleanup: Sweep up and place in suitable closed containers for disposal. Avoid generating dust. Clean contaminated surfaces with water and detergent.
Notification: Inform authorities if large quantities enter environment

Handling and Storage

Handling: Handle in a well-ventilated area. Avoid contact with skin, eyes, and clothing. Do not breathe dust or fumes. Use personal protection. Wash hands before breaks and at end of workday.
Storage: Store in tightly closed original container at room temperature (15-25°C), away from light and moisture. Keep away from incompatible substances such as oxidizing agents. Prevent storage with food, drink, or animal feedingstuffs. Ensure secondary containment for bulk storage.
Specific End Use: Pharmaceutical use, research and development

Exposure Controls and Personal Protection

Exposure Limits: No established OSHA, ACGIH, or NIOSH exposure limits. Handle as a hazardous pharmaceutical compound.
Engineering Controls: Use local exhaust ventilation and appropriate containment to prevent airborne exposure.
Respiratory Protection: Wear a NIOSH-certified dust mask or respirator if dust or mists are generated.
Eye Protection: Use chemical safety goggles.
Skin Protection: Chemical-resistant gloves (e.g., nitrile), lab coat, and protective sleeves.
Hygiene Measures: Remove contaminated clothing and wash before reuse. Wash hands, forearms, and face after handling.

Physical and Chemical Properties

Appearance: Yellow crystalline powder
Odor: Odorless
pH: Not applicable
Melting Point: 166–168°C
Boiling Point: Decomposes before boiling
Flash Point: Not available
Flammability: Non-flammable solid
Vapor Pressure: Not determined
Solubility: Sparingly soluble in water; soluble in methanol, ethanol, and acetone
Partition Coefficient (log Kow): 3.3
Relative Density: Approximately 1.40 g/cm³
Viscosity: Not applicable
Other Data: Stable under recommended storage conditions; light sensitive; may discolor on exposure to air

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions.
Reactivity: No known hazardous reactions under normal conditions.
Conditions to Avoid: Excessive heat, moisture, direct sunlight.
Incompatible Materials: Strong oxidizing agents, acids, bases.
Hazardous Decomposition Products: Toxic oxides of nitrogen and carbon may form on combustion or decomposition.
Polymerization: Not known to occur.

Toxicological Information

Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: LD50 (oral, rat): approximately 122 mg/kg;
Skin Corrosion/Irritation: Causes mild to moderate irritation
Serious Eye Damage/Irritation: Causes moderate to severe irritation
Respiratory Sensitization: May cause respiratory tract irritation
Skin Sensitization: Rarely reported; monitor for allergic reactions
Chronic Effects: Prolonged or repeated exposure can cause central nervous system effects, hypotension, dizziness
Carcinogenicity: Not listed by IARC, NTP, or OSHA as a carcinogen
Reproductive Toxicity: Animal data suggest possible effects at high doses; avoid contact if pregnant
Specific Target Organ Toxicity: May affect heart, blood vessels, nervous system

Ecological Information

Ecotoxicity: Toxic to aquatic organisms with long-lasting effects. LC50 (fish, 96hr): > 50 mg/L.
Persistence and Degradability: Poorly biodegradable, potential for bioaccumulation in aquatic environments
Mobility in Soil: Low mobility, binds to soil and organic matter
Bioaccumulative Potential: Moderate based on log Kow
Other Adverse Effects: Do not allow material to reach groundwater, sewage, or water bodies. May be harmful to soil microflora at high concentrations.

Disposal Considerations

Waste Treatment Methods: Dispose of contents/container in accordance with local, regional, and national regulations.
Product Disposal: Incineration in an approved facility preferred. Do not discharge to drains.
Contaminated Packaging: Dispose as hazardous waste. Triple rinse containers before disposal, or return to supplier/refiller.
Special Notes: Do not reuse empty containers. Document destruction per hazardous pharmaceutical requirements.

Transport Information

UN Number: Not assigned
UN Proper Shipping Name: Not regulated for transport under UN, IMO, IATA, or DOT regulations
Transport Hazard Class: Not classified
Packing Group: Not assigned
Environmental Hazards: Not classified as a marine pollutant; avoid bulk spillages in transit
Special Precautions for Users: Secure tightly during transport. Keep away from incompatible substances, food, or animal feed.
Transport in Bulk: Not relevant

Regulatory Information

U.S. OSHA: This material is regulated under the Hazard Communication Standard (HCS).
TSCA: Not listed for commercial uses in the U.S.
SARA Title III Section 313: Not subject to reporting
California Proposition 65: Not listed
EU REACH: Not registered for commercial use
Other International Regulations: Ensure compliance with all applicable local, national, and international regulations on hazardous substances. Track for changes in pharmaceutical stewardship requirements.
Labeling: Product labels must comply with GHS and other local labeling standards for hazardous chemicals.