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Product Name: Saxagliptin Monohydrate
Chemical Formula: C18H25N3O2·H2O
Chemical Family: Dipeptidyl peptidase-4 (DPP-4) inhibitor, pharmaceutical ingredient
Molecular Weight: 333.41 g/mol (Anhydrous), 351.43 g/mol (Monohydrate)
Synonyms: BMS-477118, Onglyza
Manufacturer: Bristol-Myers Squibb and related licensees
Emergency Contact: Local poison control center or regulatory agency as appropriate
Intended Use: Active pharmaceutical ingredient for oral hypoglycemic medication
GHS Classification: Not classified as hazardous under GHS criteria for physical or health hazards
Main Hazards: May cause irritation to eyes, skin, and respiratory tract on contact
Target Organs: Possible effect on pancreas and blood glucose regulation
Warning Labels: Avoid ingestion, inhalation, or skin absorption
Signal Word: No signal word required for bulk pharmaceutical use, general caution advised
Precautionary Statements: Avoid dust formation, provide adequate ventilation, prevent eye and skin exposure
Potential Health Effects: Prolonged or repeated contact may aggravate medical conditions or cause sensitization in some users
Component: Saxagliptin Monohydrate
CAS Number: 945667-22-1
Concentration: 100% (pure API)
Impurities: Trace synthetic intermediates, water of hydration
Additional Information: No excipients present in raw material form
Eye Contact: Rinse immediately with water for at least 15 minutes, hold eyelids open, remove contact lenses if present.
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, seek medical advice if irritation develops.
Inhalation: Move to fresh air, keep at rest, seek medical attention for difficulty in breathing or persistent symptoms.
Ingestion: Rinse mouth with water, do not induce vomiting, obtain medical attention promptly.
Special Attention: Show MSDS to medical personnel, monitor blood glucose in case of accidental ingestion by non-diabetics.
Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide.
Specific Hazards: Combustion produces oxides of carbon and nitrogen.
Protective Equipment for Firefighters: Use self-contained breathing apparatus and full protective gear.
Special Procedures: Avoid raising dust, fight fire from upwind if possible, prevent runoff to waterways.
Explosion Data: Not considered an explosion hazard in solid form, fine dust may present risk in confined spaces.
Personal Precautions: Evacuate exposed individuals, wear suitable protective clothing, gloves, and eye/face protection.
Environmental Precautions: Prevent spills from entering drains, sewers, or surface water.
Clean-Up Methods: Dampen powder with water to prevent dusting, collect by mechanical means, place in sealed container for disposal.
Decontamination: Wash surfaces with detergent solution, ventilate area after clean-up.
Waste Disposal: Dispose according to local, regional, and national regulations.
Handling: Use local exhaust ventilation, avoid creating dust, minimize contact with skin and eyes, prevent inhalation.
Hygiene Recommendations: Wash hands after handling, avoid eating, drinking, or smoking in work area.
Storage Conditions: Store in a tightly closed container, in a cool, dry, and well-ventilated place, away from incompatible substances.
Temperature Limits: Store at controlled room temperature, avoid excessive heat and humidity.
Special Requirements: Separate from foods, beverages, and animal feed. Secure against unauthorized access.
Exposure Limits: No established occupational exposure limits for the active substance.
Engineering Controls: Use enclosed processes, local exhaust, or other controls to keep airborne exposure below recommended standards.
Respiratory Protection: Use NIOSH-approved particulate respirator if exposure risk exists.
Skin Protection: Wear chemical-resistant gloves and lab coats.
Eye/Face Protection: Safety goggles or face shield as appropriate.
Additional Controls: Personal protective equipment should be consistent with local regulatory requirements and the scale of use.
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH (in water): Not determined
Melting Point: Approximately 139–141°C (hydrochloride form)
Boiling Point: Not applicable; decomposes before boiling
Solubility: Freely soluble in DMSO and methanol, sparingly soluble in water
Vapor Pressure: Not applicable at ambient temperatures
Partition Coefficient: Log Kow not established
Flash Point: Not available; not flammable under typical conditions
Evaporation Rate: Not applicable
Relative Density: Not determined
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions.
Reactivity: No dangerous reactions reported under normal use and storage.
Conditions to Avoid: Exposure to heat, moisture, strong oxidizing or reducing agents.
Incompatible Materials: Strong acids, bases, and oxidizing materials.
Hazardous Decomposition Products: Thermal decomposition may release carbon monoxide, carbon dioxide, and nitrogen oxides.
Polymerization: No hazardous polymerization expected.
Acute Toxicity: Toxicological data for humans are limited; animal data indicate low acute oral toxicity.
Routes of Exposure: Inhalation, skin and eye contact, ingestion.
Symptoms of Exposure: May cause gastrointestinal discomfort, headache, or mild irritation to skin, eyes, and respiratory system.
Carcinogenicity: Not listed by IARC, NTP, or OSHA as a carcinogen.
Mutagenicity: Negative in standard battery of genotoxicity tests.
Reproductive Effects: Animal studies do not show reproductive toxicity.
Sensitization: Rare cases of skin sensitization in occupational settings.
Chronic Effects: Chronic occupational exposure can pose risk for those with pre-existing allergies or sensitivities.
Ecotoxicity: No significant acute aquatic toxicity expected at low environmental concentrations.
Persistence and Degradability: Data not fully established; parent compound shows some resistance to biodegradation in laboratory studies.
Bioaccumulation Potential: No significant bioaccumulation anticipated due to chemical structure.
Mobility in Soil: Expected low mobility, limited potential for groundwater contamination.
Long-Term Effects: Limited evidence of chronic ecological risks, but proper disposal prevents environmental exposure.
Waste Handling: Collect and place material in sealed, labeled containers.
Disposal Methods: Incinerate in licensed facility or send to approved chemical waste landfill, in accordance with local and federal regulations.
Contaminated Packaging: Triple rinse and destroy by incineration if possible.
Precautions: Do not dispose of in municipal sewer or household trash.
Regulatory Basis: Follow all applicable waste management and environmental protection laws.
UN Number: Not classified as hazardous for transport
Proper Shipping Name: Not regulated
Transport Hazard Class: None
Packing Group: Not applicable
Hazard Label: None required
Special Precautions for Users: Secure containers against damage; transport in accordance with state, federal, and international regulations.
Environmental Hazards: Not considered a marine pollutant.
OSHA Status: Not regulated as hazardous
TSCA Status: Not listed
SARA Title III: Not an extremely hazardous substance
RCRA Status: Not listed as a hazardous waste
Canada DSL/NDSL: Consult Canadian authorities for status
EU Regulation: Not classified as hazardous under Regulation (EC) No 1272/2008
Other Regulations: Controlled for pharmaceutical use only; subject to prescription, licensing, and restricted handling by trained personnel
Safety, Health, and Environmental Regulations: Maintain compliance with worker protection, reporting obligations, and chemical management rules as appropriate for API manufacturing and laboratory settings.
