Material Safety Data Sheet (MSDS) for Premarin

Identification

Product Name: Premarin
Synonyms: Conjugated Estrogens, Conjugated Equine Estrogens
Product Use: Hormone replacement therapy
Manufacturer: Pfizer Inc.
Emergency Contact: 24-hour emergency hotline provided by manufacturer
Product Code: Refer to packaging specifics
Address: Listed corporate headquarters address on packaging

Hazard Identification

Hazard Class: Target organ toxicant—reproductive system
Routes of Exposure: Inhalation, dermal, ingestion
Acute Health Hazards: May cause skin and eye irritation, dizziness, headache
Chronic Effects: Carcinogenic risk, risk of thrombosis, reproductive toxicity
Signal Word: Warning
GHS Symbols: Health hazard, exclamation mark
Pictograms: Health hazard
Precautionary Statements: Avoid contact with skin and eyes; do not inhale dust; avoid prolonged or repeated exposure

Composition / Information on Ingredients

Main Ingredient: Conjugated Estrogens—varied sulfate salts of estrone, equilin, and others
CAS Numbers: 12126-59-9 (Estrone Sulfate), multiple estrogens included
Inactive Ingredients: Lactose monohydrate, magnesium stearate, talc, sucrose, calcium phosphate and others depending on the dosage form
Concentration Range: Conjugated estrogens comprise 0.3–1.25 mg per tablet, variable percent by formulation

First Aid Measures

Eye Contact: Rinse carefully with water for at least 15 minutes, seek medical attention if irritation persists
Skin Contact: Wash immediately with soap and water, remove contaminated clothing
Inhalation: Move person to fresh air, monitor for respiratory distress, consult physician promptly
Ingestion: Rinse mouth, seek medical evaluation, do not induce vomiting unless directed by health professionals
Notes for Physicians: Symptomatic treatment recommended, provide supportive care as needed

Fire-Fighting Measures

Extinguishing Media: Use water spray, dry chemical powder, foam, or carbon dioxide
Special Hazards: Releases toxic fumes of carbon oxides, sulfur oxides, nitrogen oxides upon combustion
Protective Equipment: Firefighters require self-contained breathing apparatus and full protective clothing
Unusual Fire Hazards: Fine powder may pose a dust explosion risk in confined areas

Accidental Release Measures

Personal Precautions: Avoid contact with spilled material, use gloves and eye protection
Environmental Precautions: Prevent release into surface water, soil, and drainage systems
Cleanup Procedures: Sweep up material cautiously to avoid dust formation, place in a suitable container for disposal, ventilate area well

Handling and Storage

Handling: Handle in a well-ventilated place, minimize dust generation, wash hands thoroughly after handling
Special Precautions: Do not eat, drink, or smoke during use, avoid inhalation and prolonged contact
Storage: Store in tightly closed container at 20°C to 25°C (68°F to 77°F), away from light, moisture, and incompatible substances; store in original container
Technical Measures: Use local exhaust ventilation if risk of airborne dust exists

Exposure Controls and Personal Protection

Engineering Controls: Local mechanical exhaust preferred in areas of dust generation
Exposure Limits: No established OSHA or ACGIH exposure limits for medicinal ingredients, limit to lowest achievable levels
Personal Protective Equipment: Safety goggles, protective gloves (nitrile or latex), lab coat or coverall
Respiratory Protection: Approved dust mask or respirator when airborne exposure occurs
Hygiene Measures: Remove contaminated clothing, wash skin before eating or drinking

Physical and Chemical Properties

Appearance: Cream to off-white uncoated or film-coated tablets, varies by strength
Odor: Odorless
pH: Not applicable (solid dosage form)
Melting Point: >180°C (for primary active ingredients)
Boiling Point: Decomposes on heating
Solubility: Slightly soluble in water, more soluble in organic solvents
Partition Coefficient: Not readily determined for complex mixture
Other Data: Tablets are stable under normal storage conditions

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: Avoid oxidizing agents, strong acids, and bases
Conditions to Avoid: Excessive heat, moisture, sources of ignition
Hazardous Decomposition: Carbon oxides, sulfur oxides, nitrogen oxides released during decomposition
Polymerization: No risk of hazardous polymerization

Toxicological Information

Routes of Exposure: Eyes, skin, inhalation, ingestion
Acute Effects: May cause mild skin and eye irritation, respiratory discomfort
Chronic Effects: Associated with increased risk of venous thromboembolism, some carcinogenic potential (breast, endometrial), endocrine disruption, changes in liver function, reproductive toxicity
Reproductive Hazard: Documented impacts on fertility and fetal development
Carcinogenic Classification: IARC Group 1 (Carcinogenic to humans, as per estrogen component)

Ecological Information

Ecotoxicity: Hormones pose significant risk to aquatic life, disrupts endocrine system in fish and amphibians at low concentrations
Persistence and Degradability: Active ingredients poorly biodegradable, may persist in water and soil
Bioaccumulation: Some risk of bioaccumulation in aquatic organisms
Mobility in Soil: Potential mobility, risk to groundwater difficult to predict

Disposal Considerations

Waste Disposal Methods: Dispose by incineration at licensed facility, or in accordance with local, regional, and national regulations
Unused Product: Don’t flush or release to wastewater, return to pharmacy for safe disposal
Contaminated Packaging: Treat as hazardous pharmaceutical waste, incinerate or landfill as regulated

Transport Information

UN Number: Not classified as hazardous for transport purposes
Shipping Name: Conjugated estrogens, tablets or bulk powder
Transport Hazard Class: Not regulated as dangerous goods
Packing Group: Not applicable
Special Precautions: Ship in closed containers, protect from physical damage and moisture

Regulatory Information

Regulation Status: Prescription pharmaceutical, regulated by FDA (US), EMA (EU), local drug authorities
OSHA Classification: Not specifically regulated
GHS Label Elements: Health hazard warnings as appropriate
Other Regulations: Listed in medical product databases globally, subject to environmental restrictions on disposal
Workplace Control: Control guidelines for handling active pharmaceutical ingredients in occupational settings enforced in many jurisdictions