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Product Name: Famotidine Dihydrochloride
Chemical Name: (S)-((2-Guanidino-4-thiazolyl)methyl)isothiourea dihydrochloride
Synonyms: Famotidine Hydrochloride, N-(S-(aminomethyl)-3-((2-guanidino-4-thiazolyl)methyl)isothiourea, dihydrochloride
Manufacturer: Contact details of the relevant supplier or manufacturer
Recommended Use: Active Pharmaceutical Ingredient; only skilled professionals should handle
Emergency Phone: 24-hour local poison control or medical emergency line
Chemical Formula: C8H16N7O2S3 • 2HCl
Molecular Weight: 389.33 g/mol
Product Code: Provided by the vendor or manufacturer for traceability
GHS Classification: Not classified as hazardous according to GHS guidelines; often handled as a pharmaceutical-grade ingredient
Hazard Statements: May cause mild skin or eye irritation by contact; dust may cause respiratory irritation if handled in powder form
Signal Word: None usually assigned for this active ingredient in controlled settings
Symbol: No GHS pictogram required
Potential Health Effects: Mild transitory irritation to eyes, nose, skin, and mucous membranes if handled in bulk or powder form without protection
Environmental Effects: Low short-term risk, but responsible handling and disposal remains important for aquatic environments
Routes of Exposure: Inhalation, skin, eye, ingestion
Chemical Composition: Pure Famotidine Dihydrochloride, typically greater than 98% purity
CAS Number: 76824-35-6
Impurities: Trace synthesis-related organic or inorganic residues, less than 1% in total; specifics available from batch certificate
Other Components: No known significant excipients or additives in raw bulk API form
Form: Fine, white or off-white crystalline powder
Inhalation: Move to fresh air and keep comfortable; seek prompt medical attention if irritation persists; provide oxygen or artificial respiration if needed
Eye Contact: Rinse with plenty of water for several minutes; remove contact lenses if present and easy to do; seek medical evaluation for persistent discomfort
Skin Contact: Wash area with soap and water; remove contaminated clothing and wash before reuse; monitor for rash or persistent irritation
Ingestion: Rinse mouth with water; do not induce vomiting; seek medical advice for large accidental ingestion, especially in vulnerable individuals
Symptoms to Watch: Redness, itching, sneezing, mild coughing, eye watering, possible nausea if ingested in quantity
Suitable Extinguishing Media: Use carbon dioxide, dry chemical powder, foam, or water spray for surrounding fire
Specific Hazards: Non-flammable under normal conditions; may decompose on very strong heat to release nitrogen oxides, sulfur oxides, hydrogen chloride
Protective Equipment: Self-contained breathing apparatus and full protective gear recommended for fire conditions involving chemicals
Special Instructions: Cool adjacent containers with water spray to prevent pressure buildup; avoid breathing decomposition products
Unusual Fire Hazards: None expected at typical storage or use concentrations, but bulk material exposed to intense heat may degrade
Personal Protection: Use gloves, goggles, and mask to prevent irritation from dust
Environmental Protection: Prevent bulk spills from entering drains or watercourses; contain at source if safe
Spill Clean-Up: Sweep up with care to minimize airborne dust; transfer to labeled disposal container for chemical waste
Decontamination: Wash area with water and mild detergent after removal of solids
Disposal of Waste: See disposal considerations below
Handling Precautions: Minimize airborne dust generation; avoid direct contact with skin, eyes, clothing; handle on clean, dry surfaces
Storage Conditions: Store in tightly closed container in cool, dry, and well-ventilated location away from strong oxidizers and moisture
Temperature Requirements: Store at controlled room temperature, usually not above 25°C; do not freeze
Incompatible Materials: Keep away from acids, bases, and oxidative chemicals
Hygiene Practices: Wash hands thoroughly after handling; do not eat, drink, or smoke during use
Occupational Exposure Limits: No established exposure limits for this compound; follow general limits for pharmaceutical dust or nuisance dust
Engineering Controls: Local exhaust ventilation, dust extraction preferred where large quantities handled
Personal Protective Equipment: Chemical-resistant gloves, safety goggles, laboratory coat, dust mask or respirator for dust-generating work
Special Instructions: Use protective barrier creams on hands if skin sensitivity noticed; wash hands and face after work
Environmental Exposure: Avoid release to the environment through proper containment measures
Appearance: White or slightly off-white crystalline powder
Odor: Practically odorless
Odor Threshold: Not established
pH: 4.5-5.5 (1% aqueous solution)
Melting Point: Decomposes above 220°C
Boiling Point: Not applicable (decomposes)
Flash Point: Not flammable
Solubility: Freely soluble in water; slightly soluble in ethanol
Partition Coefficient: Data not available
Vapor Pressure: Negligible; not expected to form vapor
Bulk Density: 0.5-0.7 g/cm³ (loose powder)
Chemical Stability: Chemically stable under normal temperatures and handling conditions
Reactivity: Does not react with most materials under ambient conditions
Hazardous Polymerization: Not expected
Matrix Sensitivity: Sensitive to strong acids, strong bases, and oxidizing agents
Decomposition Products: Thermal decomposition may yield hydrogen chloride, nitrogen oxides, sulfur oxides, toxic fumes if exposed to fire or high heat
Other Information: No known risk of explosive dust clouds under pharmaceutical production or laboratory scale
Acute Toxicity: Oral LD50 (rat) > 5000 mg/kg; considered low acute toxicity
Routes of Exposure: Inhalation, ingestion, skin, eye contact
Irritation: Slightly irritating to skin, eyes, and respiratory tract at high concentrations
Chronic Effects: No known significant effects in humans with normal pharmaceutical handling; animal testing at high doses shows low risk for chronic toxicity
Carcinogenicity: Not listed as a known human carcinogen
Mutagenicity: Standard testing has not revealed significant mutagenic risk
Reproductive Toxicity: No evidence for reproductive risk in controlled studies
Target Organs: Not specifically identified at normal occupational exposure
Ecotoxicity: Not acutely toxic to aquatic life at pharmaceutical concentrations; limited environmental mobility
Persistence/Degradability: Expected to biodegrade slowly; likely to adsorb to soils and sediments in small amounts
Bioaccumulation: Not predicted to bioaccumulate due to high water solubility and low lipid solubility
Aquatic Impact: Keep out of watercourses by responsible disposal; long-term ecological risks are low, but pharmaceuticals in water can pose cumulative concerns
Soil Mobility: Tends to remain near surface of soil, limited leaching under normal conditions
Waste Handling: Collect in sealed container; send to licensed chemical disposal facility; avoid direct disposal into natural environment
Disposal Method: High-temperature incineration or landfill under controlled regulations; do not burn in open areas
Container Cleaning: Rinse empty containers well before disposal; treat rinsate as chemical waste
Regulatory Advice: Follow local, regional, and national hazardous waste guidelines; pharmaceutical waste should not enter non-specialized landfill
UN Number: Not regulated for transport
Transport Hazard Class: Not classified as dangerous for road, rail, air, or sea
Packing Group: Not assigned
Labeling Requirements: None required under standard shipping guidelines for non-hazardous chemicals
Special Precautions: Keep container tightly closed and protected from moisture, away from incompatible materials and sources of heat
Bulk Transport: Must be packed to prevent dust release in transit
Global Inventory Status: May be listed under active pharmaceutical ingredient regulations in most regions
US TSCA: Exempt (pharmaceutical use)
EU Regulations: Not classified as hazardous under CLP Regulation
Canada (DSL/NDSL): Exempt or not listed; for pharmaceutical use only
WHMIS Classification: Non-controlled
OSHA Hazard Communication: Exempt for finished pharmaceuticals; laboratory use may require hazard communication training
Other Labeling: Must meet pharmaceutical production labeling laws for identity and traceability
