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Product Name: Ranolazine
Chemical Name: N-(2,6-dimethylphenyl)-2-(4-morpholinyl)ethylamine
Synonyms: Ranexa, RS-43285
Recommended Use: Pharmaceutical for the treatment of chronic angina
Manufacturer Details: Provided by pharmaceutical companies and listed on packaging
Emergency Contact: Refer to local poison control centers or manufacturer’s support line
CAS Number: 95635-55-5
Molecular Formula: C24H33N3O4
Molecular Weight: 427.5 g/mol
Classification: Not classified as hazardous under GHS for industrial handling
Physical Hazards: May cause slight skin or eye irritation; no major combustion risk
Health Hazards: Potential for headache, dizziness, nausea from inhalation or accidental ingestion
Environmental Hazards: Toxic to aquatic life in concentrated quantities
Label Elements: No symbol or signal word required for finished dosage forms
Pictograms: None required for pharmaceutical product
Precautionary Statements: Wash after handling; avoid direct inhalation or contact with eyes and skin; use only as directed
Active Ingredient: Ranolazine (concentration varies by tablet strength: 500 mg, 750 mg, 1000 mg)
Inactive Ingredients: Hypromellose, magnesium stearate, microcrystalline cellulose, coloring agents, carboxymethylcellulose sodium, Polyethylene glycol (PEG), titanium dioxide, other coating agents
Impurities: Trace process-related substances may be present in minute, non-toxic amounts
Form: Film-coated tablets or API powder
Eye Contact: Flush eyes gently with water for several minutes, remove contact lenses; seek medical attention if irritation persists
Skin Contact: Wash area with soap and plenty of water, remove contaminated clothing
Inhalation: Move to fresh air, provide artificial respiration if breathing has stopped, seek medical assistance
Ingestion: Administer water, never induce vomiting, obtain medical help
Acute Symptoms: Look for dizziness, weakness, or irritation, especially with significant exposure
Suitable Extinguishing Media: Water spray, alcohol-resistant foam, carbon dioxide, dry powder
Hazardous Combustion Products: May emit carbon oxides, nitrogen oxides, noxious fumes during burning
Firefighting Instructions: Firefighters should wear self-contained breathing apparatus, protective clothing; avoid inhalation of smoke
Unusual Fire/Explosion Hazards: Powder presents slight dust explosion potential if finely dispersed
Personal Precautions: Use gloves, goggles, dust mask; restrict access to area
Environmental Precautions: Keep spills out of sewers, waterways
Spill Cleanup Methods: Sweep up or vacuum in manner minimizing dust, transfer to closed container for disposal, wash residues with copious water
Large Spills: Use industrial absorbent or spill kits; ventilate area
Handling: Wear gloves, goggles when handling API or bulk powder; avoid dust creation, wash hands thoroughly after handling
Storage Conditions: Store in tightly sealed container below 25°C, away from direct sunlight and moisture
Incompatibilities: Do not store with oxidizing agents or strong acids; keep away from food and drink
Special Precautions: Avoid contamination with incompatible materials, ensure labeled storage areas for pharmaceutical compounds
Control Parameters: No occupational exposure limit assigned; minimize airborne concentrations
Engineering Controls: Use with adequate ventilation—fume hood or local exhaust preferable
Personal Protective Equipment (PPE): Safety glasses/goggles, protective gloves (nitrile or latex), lab coat or apron, dust mask/respirator
Hygiene Measures: Wash exposed skin after handling; avoid eating, drinking, or smoking while handling bulk material
Appearance: White to off-white crystalline solid or powder (API); white or colored oblong tablet (finished dosage)
Odor: Odorless or faint chemical odor
Molecular Weight: 427.5 g/mol
pH (for solution): Slightly acidic to neutral (5.0–7.5)
Melting Point: 118–122°C
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Slightly soluble in water, more soluble in organic solvents (ethanol, methanol)
Partition Coefficient: LogP ~ 2.3
Vapor Pressure: Negligible at room temperature
Specific Gravity: 1.2–1.3
Chemical Stability: Stable under recommended storage conditions, light sensitive
Conditions to Avoid: Avoid excessive heat, sunlight, and moisture
Incompatible Materials: Strong acids, oxidizing agents
Hazardous Decomposition: May yield carbon monoxide, carbon dioxide, nitrogen oxides under fire
Reactivity: Not known to be violent or highly reactive with typical laboratory chemicals
Acute Toxicity: No human lethality at therapeutic exposure; high intake may cause dizziness, vomiting, CNS effects
Skin/Eye Contact: Mild irritation possible, not strongly sensitizing
Inhalation: May cause mild respiratory tract irritation, especially as fine powder
Ingestion: Nausea, dizziness, heart rhythm effects reported in overdose
Chronic Exposure: No evidence of carcinogenicity or mutagenicity; animal studies show low systemic toxicity
Routes of Exposure: Oral, inhalation, skin/eye absorption
Ecotoxicity: Hazardous to aquatic organisms in bulk quantities; finished tablets pose negligible risk
Environmental Fate: Limited degradation in water, persistent in soil; not bioaccumulative in mammals
Mobility: Low mobility in soil, potential run-off hazard with spills
Degradability: Not readily biodegradable, breakdown slow in the environment
Aquatic Toxicity: LC50 (fish): data not fully defined, caution warranted near waterways
Product Disposal: Dispose of unused material through licensed chemical waste contractor
Container Disposal: Triple rinse and dispose of in accordance with local regulations
Methods: Do not flush to sewer, landfill only if allowed under pharmaceutical waste guidelines
Precautions: Keep out of reach of children and households; only trained staff should handle large quantities
UN Number: Not classified as dangerous for transport under ADR/RID, IMDG, IATA
Proper Shipping Name: Not regulated for finished pharmaceutical tablets
Hazard Class: Not regulated
Packing Group: Not regulated
Special Precautions: Avoid transporting with foodstuffs, personal protective equipment for spill cleanup in transit
Regulatory Status: Approved pharmaceutical; subject to prescription controls
EU Classification: Not classified as a hazardous substance or mixture
OSHA Status: Not subject to specific OSHA standards; handle as low-toxicity chemical
WHMIS (Canada): Not a controlled product
California Proposition 65: Not listed
Other Regulations: Comply with national and regional guidelines for pharmaceutical handling, storage, and waste
