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Product Name: Dapagliflozin Monohydrate
Chemical Name: (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol monohydrate
CAS Number: 960404-48-2
Molecular Formula: C21H25ClO6•H2O
Molecular Weight: 408.88 g/mol
Product Use: Pharmaceutical ingredient, antidiabetic drug (SGLT2 inhibitor).
Supplier Information: Manufacturer or distributor contact details should be included on packaging.
Emergency Telephone: Local poison control or company-specific emergency contact.
GHS Classification: Not classified as hazardous under GHS guidelines for normal handling and use.
Signal Word: None required.
Hazard Statements: May cause mild skin or eye irritation on direct contact. Not acutely toxic, not a respiratory hazard at room temperature. Chronic effects not fully known.
Precautionary Statements: Avoid inhalation, ingestion, contact with skin or eyes. Wash hands thoroughly after handling. Handle with adequate ventilation.
Primary Routes of Exposure: Skin, eyes, inhalation, ingestion.
Main Ingredient: Dapagliflozin Monohydrate, >97% purity for pharmaceutical grade.
Impurities: Trace process solvents, related compounds typically <0.5%.
Other Ingredients: None for pure substance. For finished dosage forms, consult finished product MSDS for excipients.
Inhalation: Move individual to fresh air. If breathing is difficult, seek medical attention.
Skin Contact: Remove contaminated clothing, rinse skin thoroughly with plenty of water and mild soap. Seek medical assessment if irritation occurs.
Eye Contact: Rinse eyes cautiously with water for several minutes. Remove contact lenses if present and easy to do. Seek attention if irritation persists.
Ingestion: Rinse mouth thoroughly with water. Do not induce vomiting. Observe for symptoms and consult physician if feeling unwell.
Note to Physician: Treat symptomatically based on patient condition.
Suitable Extinguishing Media: Use foam, dry chemical, CO2, or water spray.
Special Hazards: Material may give off toxic fumes of carbon oxides, hydrochloric acid, and other hazardous decomposition products at high temperatures.
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective gear.
Fire and Explosion Data: Not highly flammable. Fine dust may form explosive mixtures with air.
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, hydrogen chloride gas, and other organics.
Personal Precautions: Wear recommended protective equipment including gloves, goggles, and dust mask. Prevent dust spread.
Environmental Precautions: Prevent product from entering surface water, sewers, or soil.
Methods for Cleaning Up: Use HEPA-filtered vacuum or damp disposable wipes. Collect into sealable container for disposal. Ventilate area, avoid raising dust.
Decontamination: Clean contaminated surface thoroughly with water and mild detergent.
Safe Handling: Handle in ventilated area. Avoid inhalation or contact with skin and eyes. Use designated equipment and procedures for potent pharmaceuticals.
Storage Conditions: Store tightly closed in original container. Keep in cool, dry, well-ventilated place away from sunlight and incompatible materials.
Incompatibilities: Strong oxidizing agents.
Specific End Use: For use by trained personnel; not for general public.
Occupational Exposure Limits: No established occupational exposure limits for dapagliflozin monohydrate.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits.
Personal Protective Equipment: Eye protection with safety glasses or goggles; gloves recommended (nitrile latex preferred); lab coat or other suitable protective clothing; NIOSH-approved dust mask for handling powders; ensure good industrial hygiene.
Environmental Controls: Avoid significant release to environment. Use containment and disposal protocols.
Appearance: White to off-white crystalline solid.
Odor: Odorless.
Odor Threshold: Not determined.
pH: Not applicable (solid substance).
Melting Point/Range: Decomposes >150°C.
Boiling Point: Not applicable.
Flash Point: Not determined/expected to be high.
Evaporation Rate: Not applicable.
Flammability: Not flammable as supplied.
Upper/Lower Flammability Limits: Data not available.
Vapor Pressure: Not measurable at room conditions.
Vapor Density: Not applicable.
Relative Density: Approximately 1.3 g/cm³.
Water Solubility: Slightly soluble; more soluble in organic solvents.
Partition Coefficient (n-octanol/water): 1.8, indicating moderate potential for partitioning into organic phases.
Auto-ignition Temperature: Not determined.
Decomposition Temperature: Decomposes above 150°C.
Viscosity: Not applicable.
Chemical Stability: Stable under recommended storage and handling conditions.
Possibility of Hazardous Reactions: Does not polymerize.
Conditions to Avoid: Elevated temperatures, exposure to light, moisture, open flame.
Incompatible Materials: Strong oxidizing agents, acids.
Hazardous Decomposition Products: Carbon dioxide, carbon monoxide, hydrogen chloride, other volatile organics.
Acute Toxicity: Low acute toxicity based on animal studies; LD50 (oral, rat) >2000 mg/kg.
Skin Irritation: May cause mild irritation.
Eye Irritation: Dust may be irritating.
Respiratory Sensitization: No data; dust may cause mild irritation.
Chronic Toxicity: Not fully evaluated for long-term effects. Animal studies do not indicate significant risk at anticipated exposure levels.
Carcinogenicity: Not listed by IARC, NTP, or OSHA.
Mutagenicity: Negative in standard genotoxicity tests.
Reproductive Toxicity: No evidence of reproductive effects in animal studies.
Other Effects: Pharmaceutical class effects (glucosuria) not expected at exposure encountered in industrial settings.
Ecotoxicity: Limited data available; not expected to pose significant environmental risk at industrial or consumer concentrations.
Persistence and Degradability: Expected to degrade slowly in the environment; hydrolysis data limited.
Bioaccumulative Potential: Moderate potential based on log Pow (1.8).
Mobility in Soil: Limited leaching expected, binds to organic fraction.
Other Adverse Effects: No data for ozone depletion, endocrine disruption, or other specific effects.
Waste Treatment Methods: Dispose of material via licensed chemical waste contractor. Incinerate or landfill in accordance with all local, regional, national, and international regulations.
Contaminated Packaging: Decontaminate with water and detergent or dispose of as hazardous waste.
Additional Information: Do not discharge to drains or natural water bodies. Follow local prescription drug disposal guidelines.
UN Number: None assigned for this substance.
Transport Hazard Class: Not regulated as dangerous goods for air, sea, rail, or road.
Packing Group: Not applicable.
Marine Pollutant: Not classified as marine pollutant.
Special Precautions: Package securely to prevent release, avoid dust formation during transport.
Labeling: Ensure clear labeling for pharmaceutical use.
FDA: Approved as active pharmaceutical ingredient.
REACH: Not registered under REACH (EU regulation), falls under exemption for pharmaceuticals.
OSHA: Not listed as hazardous; general industrial hygiene recommended.
TSCA: Exempt for pharmaceutical use.
Other Country-Specific Regulations: Compliance required per local or national pharmaceutical safety standards. Check for inclusion on chemical inventories as appropriate.
Workplace Labeling: Ensure labels include product name, hazards, and precautions as per site SOP.
