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Product Name: Aliskiren Intermediate
Chemical Family: Organic intermediate
Synonyms: Not available
Recommended Use: Pharmaceutical synthesis
Manufacturer: Supplied by contract chemical producer
Contact Information: Emergency phone number required from supplier
CAS Number: Assigned by manufacturer or research provider
Molecular Formula: Proprietary or available from batch specification
Molecular Weight: Supplied in technical data sheets
Purity: Typically >98%
Description: White to off-white powder
REACH Registration: Not relevant for intermediate handling under controlled conditions
GHS Classification: Eye irritation (Category 2A), Skin irritation (Category 2), Target organ toxicity (single exposure, Category 3)
Label Elements: Exclamation mark symbol, Warning signal word
Hazard Statements: Causes skin and serious eye irritation, May cause respiratory irritation
Precautionary Statements: Wear protective gloves, avoid dust formation, wash hands thoroughly after handling, use only outdoors or in a well-ventilated area, avoid breathing dust, fumes, or vapors
Emergency Overview: Dust may cause mild to severe discomfort to eyes, skin, or respiratory tract
Other Hazards: No validated chronic toxicity, not classified as carcinogenic, mutagenic, or reproductively toxic by public databases
Pictograms: GHS07 (exclamation mark)
Chemical Identity: Proprietary structure; known API intermediate of Aliskiren
Concentration: 95% or more pure
Impurities: Trace synthetic by-products below concern threshold (less than 1%)
Hazardous Components: No major hazardous by-products according to manufacturer
Additives or Stabilizers: No intentionally added preservatives or solvents
Ingredient Disclosure: Full chemical structure and batch details available on request under confidentiality
Inhalation: Move person to fresh air, monitor for coughing or difficulty breathing, seek medical advice if symptoms persist
Skin Contact: Wash thoroughly with water and soap for several minutes, remove contaminated clothing
Eye Contact: Rinse immediately with plenty of clean water for at least 15 minutes, lift eyelids to ensure full flushing, seek medical attention if discomfort continues
Ingestion: Rinse mouth with water, do not induce vomiting unless directed by medical personnel, seek prompt medical advice
Most Important Symptoms: Irritation, redness or burning sensation to exposed mucous surfaces
Medical Attention/Special Treatment Needed: Symptomatic and supportive care recommended, no antidote
Suitable Extinguishing Media: Water spray, dry chemical powder, carbon dioxide, foam
Unsuitable Media: Strong water jets may spread chemical dust
Specific Hazards: May emit carbon monoxide, carbon dioxide, nitrogen oxides during combustion; no explosive decomposition recorded
Protective Equipment for Firefighters: Full protective gear including self-contained breathing apparatus
Precautions: Evacuate area, control runoff, prevent smoke inhalation
Combustion Products: Thermal decomposition leads to hazardous fumes, especially oxides of carbon and nitrogen
Firefighting Instructions: Approach from upwind, use spray to knock down dust, prevent contamination of water sources
Personal Precautions: Avoid breathing dust or contact with skin and eyes, use particulate respirator
Emergency Procedures: Evacuate unnecessary personnel, cordon off area, ventilate location
Containment: Prevent further spillage, use inert absorbent (such as sand or vermiculite) to contain
Cleaning Methods: Collect in labeled containers using non-sparking tools, avoid dry sweeping, clean surfaces with wet cloth or vacuum with HEPA filter
Environmental Precautions: Prevent entry into sewers, soil, or waterways, inform local authorities of releases exceeding reportable quantities
Handling: Wear laboratory coat, gloves, and goggles, avoid exposure to dust and vapors, employ local exhaust
Technical Measures: Work in chemical fume hood or ventilated enclosure, minimize aerosol generation
Safe Storage Conditions: Keep in tightly closed container at 2-8°C, protected from light, heat, moisture, and incompatible materials such as oxidizers
Storage Class: Pharmaceutical intermediates or non-flammable solids
Other Requirements: Post warning signage; store away from food and drink areas
Incompatibility: Strong acids, bases, or oxidizing agents can cause decomposition or hazardous reactions
Exposure Limits: No occupational exposure limits established for most intermediates; use as low as reasonably achievable principle
Engineering Controls: Source capture ventilation, closed systems during process operations
Eye Protection: Chemical splash goggles
Hand Protection: Nitrile or butyl rubber gloves
Skin/Body Protection: Long-sleeved antistatic laboratory coats or coveralls
Respiratory Protection: Particulate respirator suitable for chemical dust (N95 or better)
Hygiene Measures: Wash thoroughly after handling, do not eat, drink, or smoke when using this material
Environmental Exposure Controls: Prevent accidental environmental contamination through engineering and administrative controls
Physical State: Solid
Appearance: White to light off-white crystalline powder
Odor: Odorless or faint characteristic odor
Odor Threshold: Not available
pH (1% solution): Not determined
Melting Point/Range: 110-160°C depending on purity
Boiling Point/Range: Not available
Flash Point: Not determined for solid
Evaporation Rate: Not applicable
Flammability: Low, may combust in presence of strong ignition
Vapor Pressure: Negligible at ambient temperature
Vapor Density: Not available
Bulk Density: 0.4-0.7 g/cm³
Solubility: Slightly soluble to insoluble in water, soluble in common organic solvents (DMF, DMSO)
Partition Coefficient: Not determined
Auto-Ignition Temperature: Not available
Decomposition Temperature: >200°C
Viscosity: Not relevant for solid
Other Data: No known explosive or oxidizing properties
Chemical Stability: Stable under recommended conditions of storage and handling
Hazardous Reactions: No hazardous polymerization expected
Conditions to Avoid: Prolonged heat, light, and moisture exposure
Incompatible Materials: Strong oxidizing agents, acids, bases
Decomposition Products: Thermal breakdown yields carbon monoxide, carbon dioxide, nitrogen oxides
Reactivity: No significant reactivity hazards in standard laboratory processes
Other Stability Data: Shelf life determined by manufacturer’s quality testing and confirmation of chemical structure after storage
Routes of Entry: Inhalation, skin and eye contact, ingestion (accidental)
Acute Toxicity: Harmful if inhaled or swallowed, low dermal toxicity expected
Skin Corrosion/Irritation: Moderate; causes irritation with prolonged exposure
Serious Eye Damage/Irritation: Risk of redness, watering, pain
Respiratory or Skin Sensitization: Not classified as sensitizer, but data limited
Carcinogenicity: No indication in public literature
Mutagenicity: Not listed under major regulatory mutagenicity lists
Reproductive Toxicity: No known risk at permitted occupational exposure, no animal data for intermediate
Specific Target Organ Toxicity (STOT): May cause respiratory tract irritation
Chronic Toxicity: No chronic effects reported; handling recommendations based on precaution
Other Potential Effects: May aggravate pre-existing conditions involving eyes, skin, or lungs
Ecotoxicity: Data unavailable for this intermediate, treat as potentially hazardous
Aquatic Toxicity: Minimize release to waterways; lack of validated aquatic toxicity studies
Persistence and Degradability: May not be readily biodegradable; decomposition rate unknown
Bioaccumulative Potential: No data; avoid environmental release
Mobility in Soil: Not expected to volatilize, may bind or accumulate in soil matrix
Other Adverse Effects: No ozone depleting potential, not classified as Persistent, Bioaccumulative, or Toxic (PBT) substance
Preventive Actions: Contain and collect all spills, dispose via regulated chemical waste route
Waste Methods: Dispose of with hazardous chemical waste in accordance with local, state, federal, or national regulations
Container Disposal: Rinse empty containers with appropriate solvent, triple rinse, and dispose as hazardous waste
Precautions: Do not discharge to environment, do not mix with household or general waste streams
Incineration: Use licensed, high temperature facility
Disposal Restrictions: Restricted from landfill pending regulations on persistent organic pollutants
Regulatory Reporting: Notify authorities if significant spillage may pose a public health or environmental risk
UN Number: Assigned if classified as hazardous; many intermediates not regulated as transport hazard
ADR/RID Road/Rail: Not regulated for most intermediates if contained and packaged appropriately
IMDG Sea Transport: Not regulated in standard packaging amounts
ICAO/IATA Air Transport: Subject to air carrier regulations on pharmaceuticals or chemicals
Packaging Group: III (low danger), if classified
Proper Shipping Name: “Chemical, N.O.S.” if applicable
Special Precautions: Use leak-proof containers, ensure chemical compatibility, retain labels and documentation during transit
Hazard Communication: Meets criteria for local workplace hazardous labeling (such as OSHA, WHMIS, EU GHS/CLP)
Inventory Status: Intermediate not subject to inventory listing (such as TSCA or EINECS)
Labelling Requirements: Hazard symbol, signal word, hazard, and precautionary statements
SARA Title III (US): Not listed as extremely hazardous
California Prop 65: Not on Proposition 65 list to best current knowledge
REACH (EU): Exempted as an on-site isolated intermediate; extended safety data available upon request
Workplace Regulations: Follow employer’s chemical hygiene plans, comply with record-keeping
Other Regulatory Notes: Adhere to applicable national or regional chemical handling regulations, provide worker training and access to up-to-date safety documentation
