Substance Name: Zolpidem Tartrate
Synonyms: Ambien, Stilnox, Zolpimist
Chemical Formula: C19H21N3O • C4H6O6
CAS Number: 82626-48-0
Manufacturer: [Enter Manufacturer Name]
Use: Pharmaceutical agent for management of insomnia
Contact Information: [Enter contact details for safety queries and emergencies]
GHS Classification: Acute toxicity (oral), Skin irritation, Eye irritation
Hazard Statements: Harmful if swallowed; May cause skin and eye irritation; Central nervous system depressant
Signal Word: Warning
Precautionary Statements: Avoid contact with eyes, skin, and clothing; Use only in well-ventilated areas; Keep container tightly closed; Wash hands thoroughly after handling
Chemical Name: Zolpidem Tartrate
Concentration: 100% Active Ingredient
Impurities: Below relevant pharmacopoeial thresholds; include trace solvents or synthesis byproducts if available
Additional Components: None for API; finished products may contain excipients
Molecular Weight: 764.9 g/mol
Inhalation: Remove to fresh air; provide oxygen if breathing is difficult; seek medical attention right away
Skin Contact: Rinse immediately with plenty of water for at least 15 minutes; discard contaminated clothing and shoes
Eye Contact: Hold eyelids apart and flush eyes with running water for several minutes; obtain medical attention promptly
Ingestion: Do not induce vomiting unless directed by medical personnel; rinse mouth; seek immediate medical attention
Symptoms: Drowsiness, confusion, possible respiratory depression
Suitable Extinguishing Media: Use water spray, foam, carbon dioxide, or dry chemical agents
Unsuitable Extinguishing Media: None identified for lab-scale quantities
Specific Hazards: Emits toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, when heated to decomposition
Protective Equipment: Firefighters wear self-contained breathing apparatus and full protective gear
Explosion Data: Zolpidem Tartrate is not considered explosive in typical pharmaceutical handling and storage
Other Information: Move containers from fire area if it can be done safely
Personal Precautions: Wear protective gloves, clothing, and eye/face protection; avoid inhalation and skin contact
Environmental Precautions: Avoid releases to the environment; prevent entry into sewers, drains, or waterways
Containment: Use spill control materials to minimize spread
Cleanup Procedure: Collect and place material into suitable labelled container for disposal; ventilate area extensively after cleanup
Decontamination: Wash area with soap and water after material is removed; dispose cleaning materials as hazardous waste
Handling: Minimize dust generation and accumulation; keep container tightly sealed; employ local exhaust ventilation
Storage: Store away from incompatible materials, moisture, and excessive heat; secure in a cool, dry, well-ventilated place
Incompatibilities: Strong oxidizing agents
Hygiene Measures: Wash hands before breaks and at end of workday; do not eat, drink, or smoke while handling product
Transport Precautions: Ensure container is upright and secure to prevent spills
Exposure Limits: Occupational exposure limits not established for Zolpidem Tartrate; recommended to minimize exposure as per good laboratory practice
Engineering Controls: Implement adequate local exhaust ventilation and general ventilation
Personal Protection: Wear chemical-resistant gloves, protective lab coat or coveralls, and safety goggles; use dust mask or respirator if airborne particulates are generated
Environmental Controls: Provide suitable containment to prevent environmental contamination
Workplace Controls: Institute regular cleaning procedures to minimize accumulation of dusts and residues
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not available
pH: Approximately 5 (0.1% solution)
Melting Point / Freezing Point: Around 195°C
Boiling Point: Decomposes before boiling
Flash Point: Not applicable
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Not applicable (non-volatile solid)
Solubility: Freely soluble in water, slightly soluble in ethanol
Partition Coefficient (n-octanol/water): Log P = 2.8 (free base)
Vapor Density: Not applicable
Relative Density: Approximately 1.32 g/cm³
Viscosity: Not applicable
Chemical Stability: Stable under normal temperatures and pressures
Decomposition Products: Heating may produce carbon monoxide, carbon dioxide, nitrogen oxides
Conditions to Avoid: Elevated temperatures, light, moisture
Incompatible Materials: Strong oxidizing agents
Polymerization: Will not occur under recommended storage and handling conditions
Routes of Exposure: Oral, inhalation, skin, eye
Acute Toxicity: LD50 (oral, rat): ~770 mg/kg
Chronic Effects: May cause central nervous system depression with repeated use
Potential Health Effects: Drowsiness, headache, nausea, agitation, ataxia; in large doses may cause respiratory depression and coma
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Reproductive Effects: Animal studies indicate adverse effects at high doses
Sensitization: Not expected to cause skin sensitization
Mutagenicity: Not expected to be mutagenic based on standard assays
Ecotoxicity: Harmful to aquatic life with long lasting effects; aquatic toxicity data limited; avoid environmental release
Persistence and Degradability: Expected to persist under typical environmental conditions; limited biodegradability
Bioaccumulative Potential: Low estimated bioaccumulation potential
Mobility in Soil: Data unavailable; moderate potential for mobility due to water solubility
Other Adverse Effects: Do not discharge into drains or watercourses
Waste Treatment Methods: Incinerate according to local, regional, and national regulations
Unused Product: Treat as hazardous pharmaceutical waste; send to licensed disposal contractor
Contaminated Packaging: Dispose of in accordance with environmental regulations; thoroughly decontaminate before recycling or reuse if appropriate
Special Precautions: Avoid unintentional releases and minimize exposure to waste handlers
UN Number: Not regulated as a hazardous material by ADR/RID, IMDG, IATA
UN Proper Shipping Name: Pharmaceuticals, not otherwise specified
Transport Hazard Class: Non-hazardous for transport under typical shipment quantities
Packing Group: Not applicable
Environmental Hazards: Not classified as a marine pollutant
Special Precautions for User: Avoid damage to packaging, prevent spillage during loading, secure against breakage
US Federal Regulations: Zolpidem Tartrate listed as Schedule IV controlled substance under the Controlled Substances Act
TSCA Status: Not subject to TSCA inventory listing
OSHA Status: Not classified as hazardous under OSHA’s Hazard Communication Standard
EU Regulations: Classified under Regulation (EC) No 1272/2008 (CLP/GHS); subject to local pharmaceutical regulations
Other International Regulations: Subject to prescription control in most countries; consult regional and national regulations
SARA Title III: Not listed under SARA Section 313
DSL/NDSL: Listed or exempt in key pharmaceutical registers
Providing high-quality chemical products and logistics solutions for global trade partners.
