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Product Name: Tafamidis Meglumine
Chemical Name: 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid, meglumine salt
Molecular Formula: C21H19Cl2N3O6
Manufacturer: Pfizer Inc.
Synonyms: Vyndaqel, Tafamidis
CAS Number: 594839-88-0
Intended Use: Pharmaceutical ingredient indicated for the treatment of transthyretin amyloidosis cardiomyopathy and polyneuropathy
Contact Information: Emergency phone number and address provided by the supplier or manufacturer on the original shipment packaging
GHS Classification: Not classified as a hazardous substance for physical, health, or environmental hazards based on available information
Signal Word: Not applicable
Hazard Statements: Not expected to cause significant acute health effects. Dust may cause temporary mild respiratory or eye irritation. Limited toxicological data in occupational settings.
Pictograms: No pictograms required under current regulations
Precautionary Statements: Avoid inhaling dust or particles. Use personal protective equipment to prevent prolonged or repeated exposure.
Other Hazards: Pharmaceutical effects through excessive or inappropriate exposure. Chronic overexposure could pose risks based on therapeutic class, especially regarding liver, kidney, or reproductive effects.
Chemical Name: Tafamidis Meglumine
Concentration: 100% (Pharmaceutical grade)
Impurities: Trace process impurities within specification limits. Identity and levels consistent with pharmacopoeial standards.
Other Ingredients: None for pure substance; formulations may include excipients not part of this data sheet.
Molecular Weight: 451.30 g/mol
Inhalation: Remove to fresh air. Rescue breathing if breathing becomes difficult. Seek medical attention for persistent symptoms or if large quantities inhaled.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing and launder before reuse. Seek attention for persistent irritation.
Eye Contact: Flush gently with water for at least 15 minutes, holding eyelids open. Seek medical attention in case of continued discomfort or visual effects.
Ingestion: Rinse mouth. Do not induce vomiting unless instructed by medical personnel. Contact poison control or physician, especially if large doses swallowed.
Most Important Symptoms: Mild irritation possible from dust exposure. Occupational exposure rarely produces systemic effects unless underlying health conditions exist.
Immediate Medical Care Needed: Healthcare professionals should monitor for adverse reactions related to pharmaceutical action.
Suitable Extinguishing Media: Water fog, carbon dioxide, dry chemical, or foam. Use agents suitable for local fire environment.
Specific Hazards Arising from Fire: Thermal decomposition or combustion may produce carbon oxides, nitrogen oxides, hydrogen chloride, and potentially harmful organic vapors.
Protective Equipment: Firefighters require self-contained breathing apparatus and full protective gear.
Special Procedures: Avoid inhaling smoke, gases, and dust. Cool contaminated containers with water spray as needed.
Explosion Data: No known explosive properties. Product poses low risk of ignition under typical conditions.
Personal Precautions: Restrict access to unnecessary personnel. Wear controlled exposure personal protective equipment. Avoid creating dust.
Environmental Precautions: Prevent entry into drains or water sources. Notify authorities if significant contamination risk arises.
Containment Methods: Collect material mechanically. Sweep up spills and transfer to designated disposal container. Use HEPA-filter vacuum for fine dust.
Cleanup Procedures: Wash spilled area with water and detergent after removal. Discard cleaning media as hazardous pharmaceutical waste.
Reference to Other Sections: Dispose of contaminated material in accordance with disposal and regulatory sections.
Handling: Use appropriate protective gear including gloves, eye protection, and a laboratory coat. Work in well-ventilated areas or approved fume hood. Avoid generating airborne dust or vapors.
Storage Conditions: Store in tightly closed original container. Keep away from incompatible substances such as strong acids or bases. Maintain at controlled room temperature (15–30°C), and protect from moisture and direct sunlight.
Hygiene Practices: Wash hands after handling. Avoid eating, drinking, or smoking in work areas. Prevent cross-contamination.
Special Handling Recommendations: Use engineering controls such as dust extraction for bulk handling. Limit access and maintain logs for high-potency compound use.
Occupational Exposure Limits: No official permissible exposure limit set for tafamidis meglumine. Institutional control banding or exposure limits based on in-house policies for pharmaceutical ingredients.
Engineering Controls: Employ local exhaust ventilation or engineering containment (e.g., isolators) in bulk processing.
Personal Protective Equipment: Gloves (nitrile or latex), safety glasses or chemical goggles, lab coat or disposable coveralls. Respiratory protection as needed in the absence of adequate ventilation.
Skin Protection: Protective gloves and clothing recommended for all contact.
Eye/Face Protection: Tight-fitting safety goggles for bulk product or if particulate generation likely.
Work Hygiene: Routine hand washing, safe removal and cleaning of contaminated clothing, established procedures for accidental exposure.
Appearance: White to off-white crystalline powder
Odor: Odorless or faint characteristic smell
pH: Approximately neutral in aqueous suspension
Melting Point/Freezing Point: >200°C (decomposition may occur before melting)
Boiling Point: Not applicable (solid at ambient conditions)
Flash Point: Not determined; product is not volatile
Solubility: Moderately soluble in water and organic solvents
Partition Coefficient (log P): Data variable; typically within 2–4 for drug-like molecules
Vapor Pressure: Negligible at standard temperature
Density: Approximately 1.4–1.5 g/cm³
Other Physical Data: Stable under normal lab and storage conditions. Powder can form dust upon agitation.
Stability: Compound remains stable under recommended storage temperature and conditions. Avoid prolonged exposure to direct sunlight and moisture.
Hazardous Reactions: Stable in conventional laboratory environments. No significant hazardous polymerization expected.
Incompatible Materials: Strong oxidizers, acids, bases, and reactive metals can cause decomposition.
Decomposition Products: On combustion, produces carbon monoxide, carbon dioxide, nitrogen oxides, chloride fumes, and unidentified organic fragments.
Conditions to Avoid: Excessive heat, open flame, finely divided dust clouds that may present respiratory hazard.
Routes of Exposure: Inhalation, ingestion, skin, and eye contact
Acute Toxicity: Not acutely toxic at pharmaceutical exposures. Animal studies indicate high safety margin. Occupational exposure through dust may cause irritation.
Chronic Toxicity: No human data on long-term workplace exposure. Chronic therapeutic dosing can impact liver enzymes and rarely, cause reproductive or developmental effects.
Sensitization: No evidence from animal data of allergic reactions. Skin sensitization unlikely, but rare reactions always possible.
Target Organs: Animal testing suggests possible mild hepatic effect at repeated high doses. No conclusive evidence for other systemic toxicity.
Carcinogenicity: No compounds classified as carcinogenic by NTP, IARC, or OSHA in tafamidis meglumine.
Aquatic Toxicity: Limited data available; pharmaceuticals have potential to impact aquatic organisms at low concentrations. Effects most likely in sewage or hospital effluent settings.
Persistence and Degradability: Expected to be moderately persistent in aquatic environments. Standard degradation testing for APIs indicates partial breakdown over weeks to months.
Bioaccumulation Potential: Low potential for bioaccumulation due to physical properties and pharmacodynamic action.
Mobility in Soil: Moderately mobile in aqueous solutions. Binds weakly to soil and sediments, but presence in groundwater considered unlikely unless present in large quantities.
Other Adverse Effects: Environmental risk minimized by proper disposal and wastewater control. No known significant effect on the ozone layer or terrestrial life at realistic exposure.
Waste Disposal Methods: Dispose in accordance with local, regional, and national laws for pharmaceutical waste. Unused or contaminated material should be segregated and incinerated in a controlled facility licensed for hazardous pharmaceutical products.
Container Disposal: Triple-rinse and destroy containers. Do not reuse empty packaging without professional cleaning. Container remnants treated as hazardous pharmaceutical waste.
Disposal Precautions: Avoid direct release to sewer systems, soil, or surface water. Institutional waste management protocols required for finished products and bulk substances.
UN Number: Not regulated as a dangerous good for transportation by road, rail, air, or sea
Proper Shipping Name: Not regulated
Transport Hazard Class: Not classified
Packing Group: Not assigned
Environmental Hazards: Not classified as a marine pollutant
Special Precautions: Handle in accordance with good industrial hygiene and safety practices during transport. Keep container securely closed and protected from physical damage.
US Regulatory Status: Prescription pharmaceutical under FDA regulation. Also subject to OSHA Hazard Communication Standard; not classified as hazardous.
TSCA Status: Exempt for drugs and related active pharmaceutical ingredients
EU Classification: Subject to REACH as a substance used for pharmaceutical production. Not classified as hazardous under current CLP Regulation.
WHMIS Classification (Canada): Not controlled
International Regulations: Subject to country-specific drug legislation and waste regulations. Not listed as a restricted or banned substance globally.
Other Information: Worker safety training required for laboratory and manufacturing personnel. Compliance with local occupational health, environmental, and safety directives necessary for all entities handling the substance.
