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Product Name: Mavacamten
Chemical Name: (1R,2S)-2-(2-(4-(4-cyanophenyl)phenyl)-1H-imidazol-1-yl)-1-(3-(2,4-difluorobenzylamino)-3-oxopropyl)cyclopropane-1-carboxamide
CAS Number: 1642288-47-8
Molecular Formula: C27H29F2N5O2
Synonyms: MYK-461
Intended Use: Pharmaceutical, research and development
Supplier Details: Manufacturer address and contact number according to local distributor or manufacturer
Emergency Contact: Local or national Poison Control Center and manufacturer’s emergency phone line
Classification: Not classified under GHS as hazardous for laboratory use; always consult latest regulations for workplace and handling environments
Label Elements: No pictogram required under CLP; always use caution with bulk substance
Signal Word: None required for clinical dose formulation; for raw ingredient, signal word "Warning" may apply based on toxicity
Hazard Statements: Harmful if swallowed; may cause serious eye and skin irritation; suspected of damaging fertility or the unborn child from animal studies
Precautionary Statements: Avoid breathing dust, handle in well-ventilated settings, wash hands thoroughly after use, avoid contact with eyes, skin and clothing
Routes of Exposure: Inhalation, skin and eye contact, accidental ingestion
Effects of Exposure: Possible eye, skin, respiratory tract irritation; exposure at pharmaceutical production levels may pose reproductive toxicity risk
Chemical Name: Mavacamten
CAS Number: 1642288-47-8
Concentration: 98-100% (active pharmaceutical ingredient in lab supply)
Impurities: Trace synthetic precursors and intermediates subject to manufacturer’s process validation
Other Ingredients: None in active pharmaceutical ingredient powder; formulated tablets may include microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, additional excipients
Exposure Limits: No established occupational exposure limit (OEL); handle using standards for potent pharmaceutical ingredients (typically <1 µg/m³ air for uncontained operations)
Inhalation: Move exposed individuals to fresh air immediately, monitor for respiratory symptoms; seek medical attention if cough, shortness of breath or other symptoms persist
Skin Contact: Remove contaminated clothing; wash exposed skin thoroughly with soap and water for at least 15 minutes; seek medical help if irritation develops
Eye Contact: Rinse eyes under gentle running water for at least 15 minutes, keeping eyelids open; seek medical evaluation promptly if pain, redness or vision changes occur
Ingestion: Do not induce vomiting; rinse mouth with water; seek immediate medical assistance with product information label at hand
Most Important Symptoms: Irritation to eyes, skin, mucous membranes; nausea or drowsiness possible with significant ingestion or inhalation
Notes to Physician: Symptomatic treatment recommended; no specific antidote available
Suitable Extinguishing Media: Use CO2, dry chemical foam, or water spray; select agents appropriate for surrounding material
Specific Hazards from Fire: Material may decompose releasing nitrogen oxides, carbon monoxide, carbon dioxide, hydrogen fluoride, or other hazardous fumes
Protective Equipment: Wear self-contained breathing apparatus and full-body protective gear for fire situations involving large quantities of powder
Special Procedures: Containers near fire should be cooled with water spray to prevent thermal damage or pressure build-up
Personal Precautions: Avoid inhalation of dust and contact with skin, eyes; ensure adequate ventilation; use personal protective equipment including gloves and goggles
Environmental Precautions: Prevent release into drains, surface water, or soil; notify relevant authorities if significant spillage threatens the environment
Methods for Clean-Up: For small spills, use damp cloth or absorbent material; for larger spills use vacuum with HEPA filter; collect waste in secure, labeled containers for proper disposal
Decontamination: Clean affected area with water and detergent after visible material collected
Handling: Manage only in controlled access laboratories or pharmaceutical production areas; avoid dust generation; wear lab coat, eye protection, nitrile gloves; do not eat, drink, or smoke during use
Storage: Store in tightly sealed original container; keep in dry, dark, well-ventilated spot; maintain storage temperature as indicated by manufacturer, generally 2–8°C; avoid humidity and direct sunlight
Incompatibilities: Store away from strong oxidizers, acids, bases; segregate from food, feedstuffs, or personal-use products
Engineering Controls: Operate in chemical fume hood or containment isolator if handling powder; ensure air extraction and HEPA filtering
Personal Protection: Wear safety glasses or chemical splash goggles, nitrile gloves, long-sleeved gown or laboratory coat, disposable sleeve covers for handling bulk product
Respiratory Protection: Use NIOSH-certified particulate respirator (N95 or higher) if airborne concentrations may be generated; fit-testing and training essential for high-potency labs
Hygiene Measures: Wash hands and exposed skin thoroughly after use; avoid touching face, eyes
Occupational Exposure Limit: No formal OEL provided for Mavacamten on public databases; use standard controls for high-potency agents
Appearance: Off-white to light-yellow crystalline solid or powder
Odor: Odorless or faint chemical odor
pH: Not applicable for solid; solubility pH varies by formulation
Melting Point: Approximately 165–175°C depending on source
Boiling Point: Not measurable; decomposes before boiling
Solubility in Water: Poor, less than 1 mg/mL at 25°C; soluble in DMSO, ethanol, DMF
Density: 1.3–1.5 g/cm³ estimated
Partition Coefficient (log P): Approximately 2.3–2.8 predicted
Vapor Pressure: Negligible under ambient conditions
Flash Point: Not readily flammable; no specific value identified
Other Properties: Stable under recommended conditions; may undergo slow hydrolysis in aqueous environments
Chemical Stability: Stable in solid form under dry and ventilated conditions
Reactivity: Low reactivity with common laboratory reagents
Conditions to Avoid: Avoid moisture, strong oxidizing agents, temperatures above 30°C
Hazardous Decomposition Products: Nitrogen oxides, hydrogen fluoride, carbon monoxide, other toxic fumes if combusted or overheated
Polymerization: No known hazardous polymerization or instability under storage conditions
Incompatibility: Strong reducing or oxidizing agents; acids, bases
Routes of Exposure: Inhalation, dermal, ocular, ingestion
Acute Toxicity: Animal studies report oral LD50 in rats above 2000 mg/kg; clinical data limited to therapeutic exposures
Chronic Toxicity: Repeated exposure in animal models can cause cardiac and reproductive effects at high dose; long-term effects in humans unknown beyond pharmacovigilance
Irritation/Corrosion: Produces moderate eye and mild skin irritation in animal tests
Sensitization: Not classified as a sensitizer based on available data
Mutagenicity: Negative in Ames and chromosomal aberration tests; not considered mutagenic
Carcinogenicity: No identified carcinogenicity based on limited animal dosing
Reproductive Toxicity: Animal studies suggest risk to fertility and embryonic development at high doses
Human Experience: Most exposure is in controlled clinical or laboratory settings; adverse effects generally related to pharmacological action on cardiac contractility, dizziness, chest discomfort, headache
Medical Observation: Medical monitoring for personnel handling large amounts recommended; exposure should be minimized using best laboratory practices
Ecotoxicity: No comprehensive data, but structurally related compounds show moderate to high aquatic toxicity in fish and invertebrates
Persistence and Degradability: Degrades slowly under natural conditions; hydrolysis possible in water over time
Bioaccumulation Potential: Moderate due to lipophilicity, but pharmaceutical dilution in environment reduces risk
Mobility in Soil: Binding to organic matter likely, but specific data for leaching, migration not published
Other Effects: Do not allow material to enter surface waters, sewers or soil in significant quantities; monitor waste and effluent according to regulatory best practices
Product Disposal: Dispose of unused or waste material as hazardous pharmaceutical waste; incineration in approved facility strongly preferred
Contaminated Packaging: Treat empty containers and packaging as hazardous waste; rinse containers if applicable and collect rinsate for controlled disposal
Local Regulations: Follow all pertinent local, national, and international guidelines for pharmaceutical or chemical waste; do not dispose into drains or regular municipal waste stream
Precautions: Use double-bagging or sealed containers for disposal of spill cleanup materials; keep separate from general waste
UN Number: Not regulated as dangerous goods for land, air, or sea transport at clinical or laboratory scale; check for updates if shipper classifies as research chemical
Proper Shipping Name: Non-hazardous pharmaceutical chemical, not otherwise specified
Hazard Class: None for most quantities and forms
Packing Group: Not assigned
Special Precautions: Ship in sealed, labeled containers; avoid temperature extremes during transit
Regulatory Guidance: Keep documentation with shipment; ensure compliance with local and international shipping laws for pharmaceuticals and lab chemicals
US TSCA Status: Not listed as active on Toxic Substances Control Act; use restricted to research and pharmaceutical applications
FDA / EMA Status: Approved for clinical use in specific indications; not for general consumer or non-clinical workplace use
OSHA Status: Not classified as hazardous under US OSHA Hazard Communication Standard at prescribed medical doses; workplace exposures must be managed according to best practices for potent pharmaceuticals
Other Regulations: Local and national controls may apply for storage, waste, and handling as pharmaceutical active ingredient
Label Requirements: Pharmaceutical labeling and safety instructions according to country of use
SARA Title III: Not classified under US SARA for emergency planning
WHMIS (Canada): Not classified as controlled product under Canada WHMIS
Other Notes: Preparation, packaging, use subject to GMP and other regulatory frameworks in research, hospital or production settings
