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Material Safety Data Sheet (MSDS) for Esmolol Hydrochloride

Identification

Product Name: Esmolol Hydrochloride
Synonyms: Brevibloc, Esmolol HCl
Chemical Formula: C16H25NO4·HCl
CAS Number: 81147-92-4
Use: Beta-1 adrenergic receptor blocker for rapid control of ventricular rate in patients with atrial fibrillation or flutter.
Manufacturer Contact: Emergency phone numbers, addresses, and detailed company information always appear on packaging supplied with pharmaceutical samples and bulk chemical barrels. Product inquiries or safety questions go to the technical services or medical safety departments listed.

Hazard Identification

Classification: Not classified as hazardous under OSHA Hazard Communication Standard (29 CFR 1910.1200) when in pharmaceutical form, but powdered or raw chemical bulk may cause adverse health effects.
Hazard Statements: May cause respiratory irritation, potential central nervous system effects, skin or eye irritation on exposure, toxic if large quantities ingested.
Precautionary Statements: Avoid inhalation of dust, contact with eyes or skin, ingestion or injection outside clinical indication, and improper disposal.
Symbols: GHS07 (Exclamation mark).
Emergency Overview: White to off-white crystalline powder, odorless, non-flammable but may pose health risks through contact or prolonged exposure.

Composition / Information on Ingredients

Chemical Name: Esmolol Hydrochloride
Concentration: 100%
CAS Number: 81147-92-4
Impurities or Additives: Pharmaceutical preparations contain excipients like sodium chloride, sterile water for injection, but raw chemical product contains no significant additives.
Molecular Weight: 331.83 g/mol

First Aid Measures

Inhalation: Move to fresh air, keep the person at rest. Seek medical attention for persistent symptoms such as shortness of breath or dizziness.
Skin Contact: Wash gently with soap and water for several minutes. Remove contaminated clothing. Seek medical advice if irritation continues.
Eye Contact: Rinse immediately with water for at least 15 minutes. Remove contact lenses if present and easy to do. Call a physician for any persistent stinging or redness.
Ingestion: Rinse mouth. Do not induce vomiting. Seek immediate medical help, as excessive exposure may cause dangerous drops in blood pressure or heart rate.
Most Important Symptoms and Effects: May include bradycardia, dizziness, low blood pressure, weakness, respiratory irritation, or skin/eye irritation. Healthcare workers may experience effects after repeated exposure; safety protocols should be in place.

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, foam, dry chemical, or carbon dioxide. Select extinguishing media suitable for surrounding materials in case of fire.
Specific Hazards: Product itself does not burn but will decompose in a fire, emitting toxic fumes, including nitrogen oxides and hydrogen chloride vapors.
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear. Prevent run-off water from entering drains or water sources.
Special Procedures: Contain fire area, limit access, ventilate area after fire, and avoid inhaling combustion products.

Accidental Release Measures

Personal Precautions: Remove unprotected individuals, ventilate area, use protective clothing, gloves, goggles, and a respirator for large spills or powder releases.
Environmental Precautions: Avoid discharge into drains, groundwater, or surface water. Cover spill with absorbent material (paper towel, vermiculite), and contain using physical barriers where possible.
Methods for Clean-up: Carefully sweep up, collect in a container for hazardous waste disposal. Decontaminate area with soap and water. Double-bag all contaminated materials and label clearly for disposal.
Reporting Requirements: Comply with institutional or municipal reporting for hazardous pharmaceutical spills.

Handling and Storage

Safe Handling: Minimize dust generation, use local exhaust, handle only in properly ventilated rooms. Wear protective equipment whenever handling powder or solution outside closed-system containers.
Safe Storage Conditions: Store in tightly sealed containers in a dry, cool, and well-ventilated area, away from direct sunlight, incompatible substances (strong oxidizers, acids, bases), and ignition sources.
Incompatibilities: Do not store with oxidizing or reducing agents or in damp locations. Check for secondary containment and spill kits nearby in lab or pharmacy workplaces.
Special Instructions: Keep away from food, drink, and animal feed. Do not reuse empty packaging for other chemicals.

Exposure Controls and Personal Protection

Engineering Controls: Use fume hoods, biological safety cabinets, or systems with negative pressure to avoid exposure to aerosols or dusts.
Respiratory Protection: Use NIOSH-approved respirators for bulk handling or in risk of airborne powder release.
Skin Protection: Chemical-resistant gloves (nitrile, latex), long-sleeved lab coats, and closed-toe shoes.
Eye Protection: Chemical-resistant goggles and, in risk of splashes, a face shield.
Hygiene: Do not eat, drink, or smoke in the work area. Wash hands before eating or leaving workspace. Remove contaminated clothing immediately.
Workplace Limits: No established OSHA or ACGIH exposure limits for esmolol hydrochloride, but occupational health best practices suggest minimizing exposure, especially for pregnant workers or those sensitive to beta-blockers.

Physical and Chemical Properties

Appearance: White or nearly white crystalline powder.
Odor: Odorless.
Odor Threshold: Not applicable.
pH: Typically around 4.5-6.0 (1% solution in water).
Melting Point: Approximately 79–80°C.
Boiling Point: Not determined.
Flash Point: Not flammable.
Solubility: Freely soluble in water, sparingly soluble or practically insoluble in ethanol and chloroform.
Partition Coefficient (Log P): -0.4.
Vapor Pressure: Negligible at room temperature.
Bulk Density: Not determined.
Decomposition Temperature: Data not available.

Stability and Reactivity

Chemical Stability: Stable under recommended handling and storage conditions, maintains potency if kept unopened in original packaging away from light, heat, and moisture.
Incompatible Materials: Strong acids, bases, oxidizing and reducing agents.
Conditions to Avoid: Excessive moisture, heat, direct sunlight, and open containers.
Hazardous Decomposition Products: Nitrogen oxides, hydrogen chloride, carbon monoxide, carbon dioxide if decomposed during fire or thermal breakdown.
Hazardous Reactions: None known under normal use and storage.

Toxicological Information

Routes of Exposure: Inhalation, skin/eye contact, ingestion.
Acute Toxicity: Oral and intravenous exposure can cause bradycardia, hypotension, dizziness, headache, fainting, bronchospasm, or cardiac arrest in overdose.
Chronic Effects: No clear evidence of carcinogenicity, mutagenicity, or reproductive toxicity in humans, though animal studies in high doses show adverse fetal effects.
Sensitization: Prolonged or repeated contact may lead to allergic or adverse skin reactions in susceptible individuals.
Cancer Listings: Not listed by IARC, NTP, or OSHA.
Other Health Effects: Beta-blocker allergy, exacerbation of asthma, increased risk for people with cardiovascular disease or conduction abnormalities.

Ecological Information

Ecotoxicity: Limited data exists. Esmolol hydrochloride, like many pharmaceuticals, may have toxic effects on aquatic life at sufficient concentrations.
Persistence/Degradability: Moderate biodegradability in aquatic environment; not expected to rapidly degrade in wastewater treatment.
Bioaccumulative Potential: Low (log P -0.4 suggests low risk), though chronic aquatic exposure may still carry risk.
Mobility in Soil: Readily mobile in water, could leach if released in bulk.
Other Adverse Effects: No known significant atmospheric or ozone depletion potential, but responsible disposal is crucial to avoid long-term environmental exposure.

Disposal Considerations

Waste Handling: Collect residue and contaminated materials in designated containers labeled as hazardous pharmaceutical waste.
Methods of Disposal: Incineration under controlled conditions at authorized chemical waste facilities. Diluted or small amounts may go through specialized pharmaceutical destruction channels as per local regulations.
Do Not: Discharge untreated substances into municipal sewers or waterways.
Contaminated Packaging: Dispose of empty vials, bottles, or containers as chemotherapeutic/hazardous waste; do not recycle.
Important Practices: Follow all federal, state, and local regulations, and consult institutional safety officers for site-specific disposal recommendations.

Transport Information

UN Number: Not assigned for medical formulations; not regulated as a hazardous material in transport when shipped as finished pharmaceutical product.
UN Proper Shipping Name: Not classified as dangerous according to transportation regulations for finished dosage forms.
Transport Hazard Class: Not classified.
Packing Group: Not classified.
Special Precautions by Mode: Secure packaging, avoid physical damage. Ship in leakproof containers for bulk raw product. Signal “pharmaceuticals” where needed.
Environmental Hazards: Not regulated for environmental risks in transport. Secondary containment recommended for large quantities.
Other Information: Documentation should travel with shipment (including emergency contact and MSDS summary).

Regulatory Information

OSHA Classification: Non-hazardous as finished drug, raw powder handled with appropriate pharmaceutical safety precautions.
TSCA Inventory: Listed or exempt as a pharmaceutical ingredient.
RCRA Status: Not a listed hazardous waste, but pharmaceutical disposal rules apply.
DEA Status: Not a controlled substance.
Other Regulations: Complies with FDA regulations for pharmaceutical compounding, and must meet GMP standards in handling.
International Regulations: Listed or permitted as a pharmaceutical ingredient in major regulatory markets (EU, Japan, Canada). Subject to national drug safety and transportation rules.