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Product Name: Isosorbide Dinitrate Mixture (contains at least 60% Lactose, Starch, or Phosphoric Acid)
CAS Numbers: Isosorbide Dinitrate: 87-33-2, Lactose: 63-42-3, Starch: 9005-25-8, Phosphoric Acid: 7664-38-2
Recommended Use: Pharmaceutical intermediate, research chemical
Manufacturer Details: Company name, address, contact phone, emergency phone
Synonyms: ISDN blend, Diluted isosorbide dinitrate formulation
Contact Person: Safety officer or product steward with current email and extension
Product Code: Internal tracking or batch identification number assigned by the plant
Intended User: Qualified professionals in controlled environments, not for consumer or general industrial application
Classification: Explosive if desensitized below minimum percentage, irritant, hazardous to health if dust inhaled or ingested
Label Elements: Explosive symbol, skull-and-crossbones, health hazard icon
Emergency Overview: White to off-white solid or powder, possible faint chemical odor, can cause headache and cardiovascular effects
Routes of Exposure: Skin, eye, accidental inhalation or ingestion
Acute Health Effects: Vasodilation, hypotension, methemoglobinemia, dizziness, possible syncope
Chronic Health Effects: Risk of nitrate tolerance, chronic headache, altered cardiovascular response
Environmental Hazards: Harmful to aquatic organisms at high concentrations, avoid large-scale releases
Precautionary Statements: Prevent dust formation, ground equipment, avoid heat, flames, static, direct contact with skin or eyes
Main Components:
Isosorbide Dinitrate: 20-39%
Lactose, Starch, or Phosphoric Acid: ≥60% (diluent, stabilizer)
Trace Impurities: Moisture content (<1%), residual processing agents
Hazardous Components: Isosorbide Dinitrate (toxic), Phosphoric acid (corrosive, only if used as diluent above 60%)
Other Ingredients: None intentionally added; mixture is formulated to keep explosive risk low
Inhalation: Move to fresh air. Seek immediate medical attention if headache, respiratory distress, cyanosis, or drowsiness occurs. Supply oxygen if breathing is difficult.
Skin Contact: Remove exposed clothing, rinse area with water using safety shower if a large spill, wash thoroughly with soap and water; seek medical advice if irritation develops.
Eye Contact: Rinse immediately with copious lukewarm water for at least 15 minutes, keeping eyelids open. Remove contact lenses. Get prompt medical evaluation.
Ingestion: Do not induce vomiting. Rinse mouth with water, keep the person calm and at rest. Get urgent medical help. Monitor blood pressure.
Symptoms: Throbbing headache, low blood pressure, nausea, flushing, weakness; severe cases risk collapse or shock.
Advice for Medical Providers: Treat hypotension symptomatically, monitor cardiac status, methemoglobinemia suspected—give methylene blue as indicated.
Suitable Extinguishing Media: Use water spray, fog, dry chemical powder, or CO2. Avoid strong water jets, which may spread dust.
Fire & Explosion Hazards: Thermal decomposition releases toxic gases (CO, nitrogen oxides), dust can form explosive mixtures in air. Sensitivity to heat and friction.
Protective Equipment for Firefighters: Full bunker gear, positive-pressure self-contained breathing apparatus. Shields recommended for possible detonation.
Special Procedures: Evacuate area. Contain runoff, keep containers cool with spray, avoid stirring settled dust.
Combustion Products: Carbon dioxide, carbon monoxide, nitrogen oxides, hydrocarbon fragments.
Personal Precautions: Evacuate personnel, keep away from ignition sources, provide ventilation, wear appropriate PPE—lab coat, gloves, goggles, anti-static clothing, dust mask or respirator.
Environmental Precautions: Prevent entry into drains, sewers, waterways, or soil.
Containment: Dampen spill with water to minimize dust and static, gently collect spilled material with non-sparking tools, transfer to labeled disposal containers.
Decontamination: Wash area thoroughly with detergent and water, avoid dry sweeping, dispose of all contaminated materials.
Emergency Procedures: Alert response team, monitor area for persistent vapors or fumes.
Reporting Requirements: Notify regulatory agencies if large amounts are involved or if watercourse contamination occurs.
Handling: Minimize dust formation, ground all equipment, mechanically handle material with care, avoid sources of ignition, do not breathe dust, wash hands before breaks and after handling, use only outdoors or in well-ventilated area. Train all users in emergency response and proper first-aid steps.
Storage: Store in tightly closed, clearly labeled containers, away from incompatible materials (strong oxidizers, bases), keep at a stable and cool temperature (15-25°C), segregate from food and drinks. Place containers on non-conductive shelves. Monitor humidity to reduce static risk.
Incompatible Materials: Strong acids, bases, metallic powders, reducing agents.
Special Requirements: Follow strict inventory records, rotate stock, inspect regularly for damage or swelling.
Occupational Exposure Limits: Isosorbide Dinitrate OEL 0.01 ppm (inhalation), STELs may apply; refer to local regulations.
Engineering Controls: Use closed systems or enclosures, provide local exhaust ventilation at process points, maintain negative pressure in storage and weighing rooms, explosive proof electrical fixtures.
Personal Protective Equipment: Gloves (nitrile or neoprene), chemical safety goggles, laboratory coat, anti-static garments, dust respirators (P2 minimum or higher). In high exposure work, use full-face powered air-purifying respirator.
Hygiene Controls: No food, drinks, or smoking in work area, handwashing facilities readily available, shower before leaving workplace.
Appearance: White to pale beige powder or solid, odorless or faint nitrite-like odor
Molecular Weight: Mixture—main component (ISDN) 236.14 g/mol
pH: Depends on diluent, typically 4.5–6.5
Melting Point: Diluent dependent, ISDN: 70–75°C
Boiling Point: Decomposes
Solubility: Isosorbide dinitrate sparingly soluble in water, soluble in ethanol, diluents variable
Partition Coefficient (log Kow): 0.8 (ISDN)
Vapor Pressure: Negligible at room temperature
Density: 0.5–0.8 g/cm³ (mixture, diluent dependent)
Flashpoint: Not applicable (decomposes)
Autoignition Temperature: >180°C for ISDN
Explosive Properties: Exists at suppressed risk due to high dilution, but hazard increases if diluent falls below 60% or mixture dries out
Oxidizing Properties: Not classified as oxidizer, but supports combustion
Chemical Stability: Stable under recommended handling and storage conditions
Thermal Decomposition: Occurs above 120°C, releases toxic gases
Reactivity: Reacts with strong acids, strong bases, and some metals to produce hazardous gases
Conditions to Avoid: Excessive heat, open flames, sparks, static discharge, contact with incompatible chemicals, mechanical shock
Incompatible Materials: Reducing agents, oxidizers, acids, bases, alkali metals, phosphorous compounds (if not already diluent)
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide, hydrocarbon fragments
Polymerization: No data on hazardous polymerization for this mixture
Acute Toxicity: Oral LD50 (rat): 110 mg/kg (ISDN), irritation possible from excipients
Local Effects: Eye and skin irritation with direct contact
Systemic Effects: Vasodilation resulting in low blood pressure, reflex tachycardia, throbbing headache, nausea, dizziness
Chronic Toxicity: Long-term misuse may cause tolerance, chronic headaches, possible methemoglobinemia, risk of impaired oxygen transport
Mutagenicity/Carcinogenicity: No known human studies linking to cancer or mutations; occupational controls recommended
Target Organs: Cardiovascular system, central nervous system
Sensitization: Rare, but possible with chronic skin exposure
Medical Conditions Aggravated: Hypotension, anemia, cardiac insufficiency
Symptoms of Overexposure: Flushing, fainting, cyanosis, rapid heartbeat, potentially fatal depression at high doses
Fate in Environment: Expected to biodegrade slowly in aerobic conditions; risk of nitrate accumulation in water and soil
Aquatic Toxicity: May be toxic to aquatic invertebrates and fish if released in significant quantity
Mobility in Soil: Water soluble components may migrate; risk of ground contamination near large releases
Bioaccumulation Potential: Low for isosorbide dinitrate; diluents like lactose and starch generally safe
PBT/vPvB Assessment: Not expected to meet criteria for persistent, bioaccumulative, or toxic standards
Hazardous Decomposition: Nitrogen oxides, phosphorus compounds (if phosphoric acid present), may affect aquatic environments
Other Adverse Effects: High concentrations alter pH of receiving waters, disrupt biological oxygen demand if undiluted
Waste Handling: Collect all residues and contaminated materials in sealable, marked hazardous waste containers, store away from ignition sources
Disposal Method: Dispose through licensed hazardous waste contractor; incineration preferred, do not landfill in municipal waste
Contaminated Packaging: Rinse thoroughly, treat as hazardous waste; consult local environmental laws
Regulatory Requirements: Observe all federal, state, and local requirements for explosive and pharmaceutical chemicals, track disposal through manifest systems
UN Number: 3260 (Phosphoric acid, solid), 0360 (desensitized explosives, as applicable)
Proper Shipping Name: Isosorbide Dinitrate mixture, pharmaceutical raw material
Transport Hazard Class: 1.1D (explosives), 8 (corrosive if phosphoric acid present in quantity), otherwise Class 6.1 (toxic substance)
Packing Group: II or III, consult supplier depending on formulation and dilution
Labeling: Explosive, toxic, or corrosive labels as applicable
Environmental Hazard Mark: Marine pollutant symbol if shipped in bulk quantities
Special Instructions: Avoid rough handling, vibration, high temperature, segregate from food and animal feed, emergency response guide attached to shipment
US TSCA: Not listed for pharmaceutical grades
OSHA Status: Regulated as hazardous chemical
SARA Title III: Reportable under Emergency Planning and Community Right-to-Know (EPCRA)
EU Classification: Explosives Directive, REACH registration for all components, CLP labeling
WHMIS (Canada): Classified as hazardous (explosive, toxic, controlled product)
Chemical Safety Assessment: Completed as required for all precursors
Other National Inventories: Check compliance for all constituents, including isosorbide dinitrate, lactose, starch, phosphoric acid
R-phrases/S-phrases: Specific R36/37/38, S45, S53 for hazardous chemicals
Restrictions on Use: Restricted to licensed facilities with competent handling and segregation plans, transport and storage log requirements, periodic inspection by authorities
