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Product Name: Omadacycline
Chemical Name: 7-((2-((Dimethylamino)methyl)amino)acetyl)amino)-9-(2,2-dimethylpropyl)-6,7,8,9-tetrahydrotetracycline
Synonyms: NUZYRA
Molecular Formula: C29H40N4O7
Molecular Weight: 564.656 g/mol
Recommended Use: Pharmaceutical, antibiotic for bacterial infections
Relevant Identified Uses: Clinical, medicinal chemistry
Supplier Details: Pharmaceutics manufacturer or distributor contact information on retail label
Emergency Phone Number: Refer to local poison control or regulatory authority contact information
GHS Classification: Not classified; may irritate skin, eyes, or respiratory tract in concentrated forms
Label Elements: Avoid inhalation, ingestion, skin and eye contact
Signal Word: Warning
Hazard Statements: May cause allergic reactions for sensitive individuals; possible mild irritation
Precautionary Statements: Wash hands after handling, avoid aerosol or dust generation, use with adequate ventilation
Pictograms: Exclamation mark for irritation or sensitivity potential
Other Hazards: Not combustible; pharmaceutical material, not intended for direct consumer use except as prescribed
Chemical Name: Omadacycline
CAS Number: 346258-87-9
Concentration: ≥98% (pure API powder)
Impurities: Trace process impurities specific to manufacturer; not recognized as hazardous
Additives: None in active pharmaceutical ingredient; excipients present in finished drug form only
Mixture or Pure Substance: Pure substance in raw form
Other Ingredients: None present in raw API
Inhalation: Move person to fresh air immediately, seek medical attention for symptoms such as cough, difficulty breathing, or irritation
Skin Contact: Rinse affected area thoroughly with soap and water, remove contaminated clothing, consult physician if rash or irritation develops
Eye Contact: Flush eyes thoroughly with water for at least 15 minutes, lift eyelids occasionally, get medical attention if irritation persists
Ingestion: Rinse mouth with water, seek immediate medical assistance, do not induce vomiting unless instructed by medical personnel
Most Important Symptoms: Localized redness, itching, swelling, cough
Advice for First Responders: Use gloves and face protection, avoid direct contact
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical, foam
Specific Hazards Arising from the Chemical: Emits toxic fumes of nitrogen oxides and carbon oxides at high temperatures
Protective Equipment for Firefighters: Full protective gear including self-contained breathing apparatus
Special Procedures: Avoid inhalation of combustion by-products, remove all non-essential personnel from the area
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides, potentially other unidentified toxic or irritating gases
Explosion Data: No risk of explosion expected under normal conditions
Personal Precautions: Wear gloves, lab coat, and eye protection, prevent dust generation, ventilate area
Environmental Precautions: Do not allow large quantities to enter drains or watercourses, contain spillage
Spill Containment: Collect spilled material with inert absorbent (sand or vermiculite), place in labeled waste container
Cleanup Procedures: Clean area with damp cloth and detergent, dispose of contaminated material according to local regulations
Other Instructions: Report significant releases to regulatory authorities as required
Precautions for Safe Handling: Use personal protective equipment, avoid contact with skin, eyes, and clothing, wash hands before breaks and after work
Safe Storage Conditions: Store at recommended temperature (usually 2-8°C unless otherwise specified), keep container tightly closed, store away from light, moisture, and foodstuffs
Specific End Use(s): Handling by trained personnel in licensed facility
Incompatible Materials: Oxidizing agents, acids, strong bases
Packaging Materials: Store only in original containers as supplied by manufacturer
Occupational Exposure Limits: No official limit established; use pharmaceutical exposure controls (engineering or procedural as needed)
Engineering Controls: Work in well-ventilated area, use fume hood if dust or aerosol possible, local exhaust
Personal Protective Equipment (PPE): Laboratory gloves, chemical-resistant apron, safety goggles or face shield
Respiratory Protection: NIOSH/MSHA-approved respirator if dust or aerosol production cannot be avoided
Hygiene Measures: Wash hands thoroughly after handling, avoid eating, drinking, smoking in processing areas
Appearance: Yellow to orange crystalline powder
Odor: None or slight characteristic odor
pH: Not applicable (solid form); solution pH may vary 3-7 (check manufacturer data)
Melting Point/Freezing Point: Not precisely documented; decomposes before melting
Boiling Point: Decomposition before boiling
Flash Point: Not applicable
Evaporation Rate: Not applicable
Flammability: Non-flammable under normal conditions
Vapor Pressure: Not applicable
Vapor Density: Not applicable
Solubility: Slightly soluble in water, more soluble in methanol, DMSO
Partition Coefficient (log Kow): Not documented in open literature
Autoignition Temperature: Not applicable
Decomposition Temperature: Information not generally available; avoid strong heat
Chemical Stability: Stable under recommended handling and storage conditions
Reactivity: No data on hazardous reactivity under normal use
Conditions to Avoid: Strong light, moisture, excessive heat
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: Nitrogen oxides, carbon oxides, possibly toxic fumes if exposed to high temperatures
Possibility of Hazardous Reactions: None expected during normal handling
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: LD50 values not fully characterized for humans; in animals, dose-dependent effects on liver and kidneys typical for tetracycline class
Chronic Exposure: Based on similar drugs, may cause allergic or hypersensitivity reactions; prolonged exposure may affect liver
Carcinogenicity: No evidence from animal tests or clinical experience
Reproductive Toxicity: Tetracyclines interfere with infant bone and dental development during pregnancy or infancy
Specific Target Organ Toxicity: Can affect liver, gastrointestinal tract, developing teeth and bones
Other Toxic Effects: Allergic reactions (rash, anaphylaxis reported with related antibiotics)
Ecotoxicity: Limited data; tetracyclines may be toxic to bacteria, algae, aquatic organisms at low concentrations due to antibiotic properties
Persistence and Degradability: Does not rapidly degrade under environmental conditions, may persist as active compound
Bioaccumulative Potential: No significant accumulation expected in higher organisms
Mobility in Soil: Tetracycline compounds adsorb readily to soil; runoff possible in large spills
Other Adverse Effects: Potential for antimicrobial activity in ecosystems; can disrupt microbial community structure
Waste Treatment Methods: Dispose in accordance with national/local laws for pharmaceuticals, incinerate or send to licensed chemical waste handler
Product Disposal: Prevent environmental contamination by sealing in labeled hazardous waste containers
Container Disposal: Triple rinse or destroy containers, follow local or institutional procedures for hazardous pharmaceutical waste
Special Precautions: Avoid release into drains or watercourses; document all disposals for regulatory compliance
UN Number: Not regulated for transport under UN / international conventions
Proper Shipping Name: Not regulated for transport
Transport Hazard Class: Not classified as a hazardous material
Packing Group: Not applicable
Environmental Hazards: Avoid data, handle as for sensitive pharmaceuticals
Transport Precautions: Protect from moisture and physical damage, store in original container during transport
Safety, Health, and Environmental Regulations Specific for the Substance: Listed under various pharmaceutical regulations (US FDA, EMA, WHO when applicable)
OSHA Hazard Communication: Not listed as hazardous; refer to institution-specific pharmaceutical guidelines
TSCA: Not listed
SARA Title III: Not regulated
Canadian WHMIS Classification: Not controlled for workplace chemicals
Inventory Status: Compliant for pharmaceutical manufacture and prescription (specialist oversight required)
