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Material Safety Data Sheet (MSDS) for Riociguat

Identification

Product Name: Riociguat
Chemical Name: Methyl N-{4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}-N-methylcarbamate
Synonyms: BAY 63-2521
CAS Number: 625115-55-1
Recommended Use: Pharmaceutical research, pulmonary arterial hypertension therapy
Supplier: Pharmaceutical distributor or chemical supplier contact details on file
Emergency Contact: Refer to national poison center and local emergency numbers; ensure proper preparedness during handling

Hazard Identification

GHS Classification: Skin irritation, eye irritation, reproductive toxicity, acute toxicity (oral, inhalation)
Hazard Symbols: GHS07 (Exclamation mark), GHS08 (Health hazard)
Signal Word: Warning or Danger based on region
Hazard Statements: Causes skin and eye irritation, may cause damage to organs with repeated exposure, suspected of damaging fertility or the unborn child, harmful if swallowed, inhaled or absorbed
Precautionary Statements: Avoid ingestion, skin and eye contact; wear protective equipment; wash thoroughly after handling; avoid release into the environment

Composition / Information on Ingredients

Chemical Identity: Riociguat
Purity: Typically higher than 98% for research grade
Hazardous Components: Main hazard attributed to Riociguat itself
Impurities: Byproducts and unreacted precursors monitored per batch; upheld within ICH guidelines

First Aid Measures

Inhalation: Move person to fresh air, support breathing, get immediate medical attention for symptoms such as cough, difficulty breathing, dizziness
Skin Contact: Remove contaminated clothing, rinse skin with plenty of water and soap for at least 15 minutes, seek care for redness, blistering, or irritation
Eye Contact: Rinse with water or saline, keep eyelids open, flush eyes for at least 15 minutes and consult a doctor
Ingestion: Rinse mouth, do not induce vomiting, give water to conscious person, seek urgent medical advice regardless of quantity
Symptoms: Possible irritation, headaches, respiratory distress, nausea, reproductive effects long-term

Fire-Fighting Measures

Extinguishing Media: Use foam, dry chemical powder, carbon dioxide, or water spray
Hazards: Emits toxic fumes under combustion including nitrogen oxides, carbon oxides, fluorinated compounds
Protective Equipment for Firefighters: Full fire protective clothing, self-contained breathing apparatus
Special Procedures: Remove containers from fire area if possible; remain upwind; prevent firewater from seeping into drains or water sources

Accidental Release Measures

Personal Precautions: Wear gloves, goggles, lab coat, suitable respiratory protection
Environmental Precautions: Prevent entry into drains, waterways, or soil
Methods for Clean-Up: Sweep or vacuum spillage without creating dust, place residues in labeled containers for disposal, ventilate area, clean surfaces with suitable cleaning agent and water

Handling and Storage

Handling: Work in a chemical fume hood, avoid dust formation, avoid exposure through skin, eyes, and inhalation, use only with proper ventilation
Storage: Store in tightly closed container, keep at controlled room temperature (15-25°C), protect from moisture, light, heat, and incompatible substances such as strong oxidizers, acids, and bases, label shelves and bottles; store in secure area with restricted access

Exposure Controls and Personal Protection

Engineering Controls: Use biological safety cabinet for powder manipulation, install local exhaust ventilation
Personal Protective Equipment: Chemical-resistant gloves, long-sleeved lab coat or gown, safety goggles or face shield, respiratory mask when needed
Hygiene Measures: Wash hands and arms after working with material, remove contaminated clothing before leaving work area, monitor environmental levels periodically in workplace

Physical and Chemical Properties

Physical State: White to off-white powder
Molecular Weight: 422.4 g/mol
Solubility: Slightly soluble in water, higher in methanol or DMSO
Melting Point: Reported between 235-240°C
pH: Not measured for solid; no relevant data in aqueous solution
Odor: Odorless or faintly aromatic
Vapor Pressure: Not volatile at room temperature
Flash Point: Not established due to thermal decomposition prior to ignition

Stability and Reactivity

Chemical Stability: Stable in original packaging under recommended storage conditions, decomposes above 240°C
Reactivity: No significant reactivity under standard storage and handling conditions
Incompatible Materials: Strong acids, bases, and oxidizers increase hazard
Hazardous Polymerization: Not expected
Decomposition Products: Toxic gases including carbon, nitrogen, and fluorine oxides may arise from excessive heat or combustion

Toxicological Information

Routes of Exposure: Ingestion, inhalation, dermal, ocular
Acute Effects: Animal studies show oral LD50 above 300 mg/kg in rodents, moderate eye and skin irritant
Chronic Effects: Prolonged or repeated exposure could cause reproductive toxicity, possible liver, kidney, or cardiovascular effects
Other Health Hazards: Not known to be mutagenic, nor carcinogenic based on currently published investigations; fetotoxic and can impair fertility in laboratory animals at high doses

Ecological Information

Aquatic Toxicity: Bioaccumulation and toxicity data limited but risk to aquatic organisms suspected at high concentrations
Mobility in Soil: Predicted to be low; molecule binds to organic matter and degrades slowly
Persistence and Degradability: Expected to persist in soil and water for weeks, hydrolysis and photolysis slow under environmental conditions
Bioaccumulation: Potential for some bioaccumulation in aquatic organisms due to moderate log Kow based on structure
Other Adverse Effects: Avoid uncontrolled release to the environment, effects on wastewater treatment not fully established

Disposal Considerations

Waste Treatment Methods: Collect and place into tightly sealed containers; incinerate under controlled conditions, use authorized hazardous waste disposal company
Contaminated Packaging: Dispose of as hazardous waste, rinse well before disposal if permitted
Environmental Precautions: Avoid uncontrolled emissions, prevent waste from reaching water sources or soil, do not mix with regular waste streams

Transport Information

UN Number: Not classified as hazardous for transportation under most international conventions
Transport Hazard Class: Not regulated as a dangerous good
Packing Group: Not assigned
Special Precautions: Secure packaging to prevent breakage, transport away from incompatible substances, keep clear documentation, comply with national and international regulations for pharmaceuticals and laboratory reagents

Regulatory Information

Labelling: Proper GHS hazard wording and symbols required
Chemical Inventory Status: Listed only for research and medical use, not covered by general consumer regulations
Workplace Safety: Covered under OSHA, EU REACH, and similar bodies where applicable
Special Regulatory Notes: Prescription-use only, subject to medical device and pharmaceutical legislation; classified as a hazardous substance for lab workers, routine safety monitoring recommended for workplaces storing or handling quantities larger than single-use doses