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Material Safety Data Sheet: Posaconazole Intermediate / Posaconazole Intermediate 2

Identification

Product Name: Posaconazole Intermediate / Posaconazole Intermediate 2
Chemical Family: Triazole antifungal intermediates
Synonyms: Not commonly known by other names
CAS Number: Confidential per supplier specifications
Manufacturer: Specific pharmaceutical manufacturer name, address, and emergency contact number
Recommended Use: Intermediate for active pharmaceutical ingredient synthesis, research, laboratory use only

Hazard Identification

Classification: May cause eye, skin, and respiratory irritation.
Risk Phrases: Harmful if swallowed or inhaled. Can irritate eyes and skin. Not classified as carcinogen by IARC or NTP.
Hazard Symbols: Irritant (Xi), Health Hazard (GHS07)
Routes of Exposure: Eyes, skin, inhalation, ingestion
Potential Health Effects: Redness, itching, allergic reactions possible for sensitive individuals.
Precautionary Statements: Avoid breathing dust. Use personal protective equipment. Wash thoroughly after handling.

Composition / Information on Ingredients

Chemical Name: Posaconazole Intermediate 2
Formula: Proprietary structure – details are confidential per supply agreement
Concentration: Typically >98% active substance
Impurities: Trace organic solvents <1%, residual process reagents <0.1%
Additives: None

First Aid Measures

Eye Contact: Rinse immediately with plenty of water for at least 15 minutes, lifting eyelids.
Skin Contact: Remove contaminated clothes. Flush with soap and water for several minutes.
Inhalation: Move to fresh air. If breathing becomes difficult, seek medical help.
Ingestion: Rinse mouth with water. Do not induce vomiting unless directed by a physician.
Advice for Physicians: Symptomatic treatment only; provide supportive measures as needed.

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, CO2, foam, or water spray.
Hazards From Combustion: Decomposes to produce carbon monoxide, carbon dioxide, nitrogen oxides, and other toxic gases.
Special Protective Equipment: Wear self-contained breathing apparatus and protective clothing.
Special Firefighting Procedures: Use caution, avoid inhalation of smoke or vapors, contain run-off.
Explosion Data: Not classified as explosive. Fine powder can present dust explosion risk in confined areas.

Accidental Release Measures

Personal Precautions: Avoid dust formation. Wear gloves, goggles, and mask.
Spill Management: Vacuum or sweep up material for proper disposal, minimizing dust.
Environmental Precautions: Prevent entry into drains, sewers, and water bodies.
Cleaning Methods: Use damp cloth or mop for residue. Dispose of cleaning materials safely.
Decontamination: Wash hands and affected areas with soap and water post-cleanup.

Handling and Storage

Handling Precautions: Handle in a well-ventilated area. Avoid contact with skin, eyes, and clothing.
Hygiene Measures: No eating, drinking, or smoking during use. Wash hands before breaks and after handling.
Storage Conditions: Store in tightly closed original container.
Temperature Requirements: Maintain at room temperature (15-25°C) unless specified. Protect from moisture, heat, and light.
Incompatible Materials: Strong acids, strong bases, oxidizing agents.

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation.
Respiratory Protection: NIOSH-approved dust mask or respirator for large-scale handling or where dust clouds are generated.
Eye Protection: Safety goggles with side-shields.
Skin Protection: Chemical-resistant gloves (nitrile or similar); long-sleeved clothing.
Work Practices: Routine hand-washing; keep work area clean; avoid generating dust.

Physical and Chemical Properties

Appearance: Off-white to pale yellow solid or powder
Odor: Odorless or faint chemical odor
pH: Neutral in water solution
Boiling Point: Not applicable
Melting Point: 95–120°C (varies by batch and structure)
Solubility: Poorly soluble in water, soluble in most organic solvents
Vapor Pressure: Negligible
Density: 1.2–1.4 g/cm3
Flash Point: >150°C
Partition Coefficient (Log Kow): Data not available
Evaporation Rate: Not volatile under ambient conditions

Stability and Reactivity

Chemical Stability: Stable under ambient conditions in closed systems
Conditions to Avoid: Excessive heat, moisture, direct sunlight, and strong oxidizing environments
Incompatibility: Avoid contact with acids, bases, and oxidizers
Hazardous Decomposition: Emits toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides under fire or decomposition
Hazardous Polymerization: Does not occur under normal handling and storage

Toxicological Information

Acute Toxicity: Oral LD50 (rat): >2000 mg/kg (data for similar intermediates)
Skin Corrosion / Irritation: Mild irritation possible, not classified as corrosive
Eye Damage / Irritation: May cause temporary redness and discomfort
Respiratory Effects: Dust can irritate mucous membranes and upper respiratory tract
Sensitization: Rare skin or respiratory allergic responses in sensitive individuals
Chronic Effects: No evidence of carcinogenicity, mutagenicity, or reproductive effects in available studies

Ecological Information

Eco-Toxicity: Low acute toxicity to aquatic life; specific data limited, avoid uncontrolled release
Persistence and Degradability: Likely to degrade under natural environmental conditions, but can accumulate with chronic release
Bioaccumulative Potential: Not expected to bioaccumulate significantly
Mobility: Limited water solubility reduces risk of migration in groundwater
Other Adverse Effects: Not registered as hazardous to environment in standard regulatory databases

Disposal Considerations

Waste Management: Treat as hazardous chemical waste. Collect in appropriate sealed containers.
Disposal Procedures: Hand over to licensed chemical waste disposal contractor.
Contaminated Packaging: Rinse and dispose of empty containers following local guidelines.
Legal Compliance: Follow local, regional, and national regulations for pharmaceutical waste.
Avoid Release: Do not dispose of to drains, surface waters, or general waste streams.

Transport Information

UN Number: Not assigned for transport of pharmaceutical intermediates
Transport Hazard Class: Not regulated as hazardous for air, sea, or ground
Packing Group: Not applicable
Special Precautions: Keep in original container, tightly closed, and upright
Other Transport Notes: Protect from moisture and physical damage during transit

Regulatory Information

Labelling Requirements: Comply with chemical protection and workplace safety regulations
REACH Status: Not subject to registration in bulk under current provisions
OSHA Status: Not listed specifically; handle per general chemical safety law
Country-Specific Notes: Consider additional requirements per destination nation, e.g., TSCA (USA), WHMIS (Canada)
Other Relevant Laws: Classification, labelling, and packaging regulated by global agencies (GHS, IATA, IMDG, local pharmaceutical controls)