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Material Safety Data Sheet for Oritavancin

1. Identification

Product Name: Oritavancin
Synonyms: Oritavancin diphosphate, LY333328
Recommended Use: Glycopeptide antibacterial for pharmaceutical research and use
Manufacturer: Refer to the pharmaceutical supplier or lab
Emergency Contact: Supplier-provided emergency response number, local poison center
CAS Number: 171099-57-3
UN Number: Not classified as hazardous for transport under UN regulations
Address: Reference to supplier’s address
Email: Supplier contact email for MSDS or emergencies
Phone: Supplier’s direct phone number for chemical safety support

2. Hazard Identification

Hazard Class: Not classified as hazardous according to GHS criteria; handle as pharmaceutical agent
Label Elements: No hazard pictograms, no signal word
Hazard Statements: May cause mild irritation to eyes, skin, or respiratory tract if handled in dusty or unprotected conditions
Precautionary Statements: Wear suitable protective clothing, avoid inhaling dust, wash exposed skin after handling
Other Hazards: May present hazard if accidentally ingested, especially to those with known sensitivity to glycopeptide antibiotics
Pictograms: None mandated; use general laboratory safety signage as appropriate
Routes of Entry: Inhalation, skin contact, eye contact, ingestion

3. Composition / Information on Ingredients

Chemical Identity: Oritavancin diphosphate
CAS Number: 171099-57-3
Purity: Pharmaceutical–grade, typically ≥98%
Molecular Formula: C86H97Cl3N10O26•2H3PO4
Molecular Weight: Approximately 1793.6 g/mol
Impurities: Trace synthesis byproducts, usually less than 2%
Other Components: Residual solvents below ICH guideline specification, significant only if noted on specific batch COA

4. First Aid Measures

Inhalation: Move individual to fresh air; seek medical attention if symptoms develop
Skin Contact: Remove contaminated clothing, wash area with soap and water; seek assistance if irritation persists
Eye Contact: Rinse eyes thoroughly with water for minimum 15 minutes, lift eyelids often; get medical care if discomfort remains
Ingestion: Do not induce vomiting, rinse mouth with water; consult a physician immediately
Note to Physicians: Provide symptomatic and supportive care, monitor for allergic reactions based on glycopeptide class effects

5. Fire-Fighting Measures

Extinguishing Media: Use CO2, dry chemical powder, foam, or water spray on nearby fires
Special Hazards: Combustion generates toxic fumes including oxides of carbon, nitrogen, chlorine, possibly phosphorus
Protective Equipment: Self-contained breathing apparatus required, wear chemical-resistant clothing
Firefighting Procedures: Move containers from area if safe, keep cool with water spray, avoid inhalation of combustion products

6. Accidental Release Measures

Personal Precautions: Use proper personal protective equipment including gloves, lab coat, safety glasses, dust mask or respirator when handling powder
Environmental Precautions: Prevent from entering drains or water sources, contain spill to avoid contamination
Cleanup Methods: Sweep up using methods minimizing dust, transfer to a sealable labeled container for disposal; clean spill site with detergent
Disposal: Collect residues and place in a designated container for chemical waste, proceed according to institutional guidelines

7. Handling and Storage

Handling: Manage in well-ventilated space, avoid dust generation; wear PPE such as resistant gloves, goggles, lab coats
Storage Conditions: Keep container tightly sealed, store under dry, cool conditions away from light
Incompatible Materials: Strong oxidizing agents, acids, bases
General Hygiene: Do not eat, drink, or smoke in work area; practice regular hand washing and surface cleaning

8. Exposure Controls and Personal Protection

Occupational Exposure Limits: No established workplace exposure limits specific for oritavancin
Engineering Controls: Use local exhaust ventilation, laboratory fume hood recommended if powder manipulation expected
Respiratory Protection: NIOSH-approved particulate respirator recommended for significant airborne exposure
Skin Protection: Disposable nitrile gloves, long-sleeved lab coat
Eye Protection: Chemical splash goggles or safety glasses
General Controls: Wash hands after exiting work area, remove PPE before leaving workspace

9. Physical and Chemical Properties

Appearance: White to off-white powder or lyophilized solid
Odor: Odorless or faint odor
pH: Neutral to slightly acidic in solution
Melting Point: Decomposes before melting
Solubility: Soluble in water, lower solubility in most organic solvents
Boiling Point: Not applicable—decomposes
Flash Point: Not applicable, not flammable
Vapor Pressure: Not relevant (solid)
Partition Coefficient: Not available
Viscosity: Not applicable

10. Stability and Reactivity

Chemical Stability: Stable under normal storage and laboratory conditions
Reactivity: No significant reactivity with common materials unless exposed to strong oxidizing or reducing agents
Conditions to Avoid: Excessive moisture, exposure to high heat or strong light
Decomposition: May form toxic products including carbon oxides, nitrogen oxides, hydrogen chloride if burned
Polymerization: Not anticipated under recommended use

11. Toxicological Information

Acute Toxicity: Toxicological profile primarily from pharmacological studies; LD50 not precisely defined
Routes of Exposure: Skin, eye, inhalation, ingestion; main pharmacological risk relates to injection for clinical use
Health Effects: Dust may irritate eye, skin, or respiratory tract; oral ingestion likely low toxicity at small quantities, avoid exposure
Chronic Toxicity: No long-term data in non-clinical situations; glycopeptide antibiotics may cause allergic reactions with repeated exposure
Carcinogenicity: No classification based on available data
Mutagenicity: Negative in most standard genotoxicity assays
Reproductive Toxicity: Reproductive toxicity not fully assessed for incidental occupational exposure

12. Ecological Information

Ecotoxicity: Potential toxicity towards aquatic organisms cannot be excluded; antibiotics may create risk to microbial communities in the environment
Persistence and Degradability: Limited data; likely low persistence under environmental conditions, but breakdown products not well studied
Bioaccumulative Potential: No evidence of significant bioaccumulation
Mobility in Soil: Expected low mobility due to molecule size and charge
Other Detrimental Effects: Risk to wastewater treatment systems due to antimicrobial properties, use containment and proper waste disposal at all times

13. Disposal Considerations

Waste Disposal Methods: Dispose of unused product and contaminated disposables as chemical waste; incineration recommended in accordance with institutional, local, and federal requirements
Container Disposal: Triple rinse containers before disposal or incineration; label appropriately
Further Information: Avoid release to environment or sewage system, coordinate with hazardous waste authorities for all disposal

14. Transport Information

UN Number: Not regulated for transportation
Proper Shipping Name: Oritavancin, not classified as a hazardous material
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Special Transport Precautions: Ship in secure container, protect from physical damage; avoid direct sunlight and high humidity
Environmental Hazards: Not listed as marine pollutant

15. Regulatory Information

Global Inventory Status: Not listed on EINECS/ELINCS, TSCA, DSL
GHS Classification: Not a hazardous substance or mixture
OSHA Status: Not regulated
Other Regulations: Comply with all relevant international, national, and regional regulations regarding pharmaceutical substances
WHMIS Classification: Not controlled
REACH Status: Not registered in Europe for industrial or commercial use
SARA Title III: Not subject to reporting requirements
Labelling Requirements: Use labels indicating research chemical, not for human consumption outside licensed indications