Material Safety Data Sheet: Sodium Risedronate

Identification

Product Name: Sodium Risedronate
Chemical Name: Sodium 4-(chlorophenyl)-2-phosphono-1,3,5-triazine-4,6-disulfonate
CAS Number: 115436-72-1
Synonyms: Risedronic acid monosodium salt, Sodium risedronate sesquihydrate
Manufacturer: [Company Name, Address]
Recommended Use: Pharmaceutical active ingredient
Restrictions on Use: Reserved for industrial, laboratory, or professional use
Emergency Contact: [24-hour emergency number]

Hazard Identification

Classification (GHS): Acute Toxicity Category 4 (Oral), Eye Irritation Category 2A
Signal Word: Warning
Hazard Statements: Harmful if swallowed; Causes serious eye irritation
Pictograms: Exclamation mark
Precautionary Statements: Wash hands thoroughly after handling; Do not eat, drink or smoke when using; Wear protective gloves, eye protection
Potential Health Effects: Eye and gastrointestinal irritation, possible kidney effects with repeated exposure
Environmental Hazards: Small risk to aquatic environment; do not release to open drains

Composition / Information on Ingredients

Chemical Identity: Sodium risedronate
CAS Number: 115436-72-1
Concentration: >98% by weight
Impurities/Additives: None known at levels of significance
Other Components: Hydrate water (if present at pharmaceutical grade)
Molecular Formula: C7H10N2NaO7P2
Molecular Weight: 305.09 g/mol

First Aid Measures

Eye Contact: Rinse immediately with clean water for at least 15 minutes, seek medical attention
Skin Contact: Wash with plenty of water and soap, remove contaminated clothing
Inhalation: Move to fresh air, keep at rest, seek medical attention if symptoms develop
Ingestion: Rinse mouth with water, give water to drink if conscious, contact physician
Most Important Symptoms: Redness or irritation of eyes, nausea, abdominal discomfort
Immediate Medical Attention: Symptomatic treatment, no specific antidote

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, foam
Unsuitable Extinguishing Media: Do not use water jet directly on burning material
Specific Hazards: Thermal decomposition releases toxic gases (phosphorus oxides, nitrogen oxides, sodium oxides, hydrochloric acid)
Protective Equipment: Self-contained breathing apparatus, full protective clothing
Special Precautions: Avoid inhaling fumes, control runoff from fire control to prevent environmental contamination

Accidental Release Measures

Personal Protection: Wear gloves, goggles, and dust mask; avoid creating dust
Environmental Precautions: Do not allow to enter sewers or waterways
Method of Containment: Sweep up material carefully, avoid scattering
Method of Cleanup: Collect in suitable containers for disposal; wash area with water and detergent
Disposal: Refer to local, regional, and national regulations for chemical waste

Handling and Storage

Handling: Avoid contact with eyes, skin, and clothing; prevent dust formation; wash hands before eating, drinking, or smoking
Storage Conditions: Store in tightly closed containers; keep in dry, cool, and well-ventilated area, away from incompatible substances
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Packaging Materials: Use non-reactive, airtight containers
Special Sensitivity: Temperature and humidity control extends shelf life

Exposure Controls and Personal Protection

Occupational Exposure Limit: No established limit for sodium risedronate
Engineering Controls: Mechanical ventilation, eyewash stations, and safety showers in proximity
Personal Protective Equipment: Safety goggles, gloves, lab coat, dust mask or respirator if dust becomes airborne
Hygiene Measures: Do not eat, drink, or smoke in work area; wash thoroughly after handling

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: Not applicable (decomposes)
Boiling Point: Not available
Solubility: Soluble in water
pH: 4.0 to 5.0 (1% aqueous solution)
Relative Density: 1.7 – 1.9 g/cm³
Flash Point: Not flammable
Vapor Pressure: Negligible at room temperature
Auto-Ignition Temperature: Not determined
Explosive Properties: Not explosive
Partition Coefficient: Log Pow = less than -2.0 (high water solubility)

Stability and Reactivity

Chemical Stability: Stable under normal conditions
Reactivity: No hazardous reactivity at ambient temperature; avoid contact with incompatible materials
Hazardous Reactions: None known under prescribed use
Conditions to Avoid: Moisture, extreme temperatures, open flames
Decomposition Products: Phosphorus oxides, nitrogen oxides, sodium oxide, hydrochloric acid
Polymerization: No hazardous polymerization

Toxicological Information

Acute Toxicity (Oral): LD50 oral (rat) > 2000 mg/kg (low toxicity)
Skin Corrosion/Irritation: Mild irritation possible
Eye Damage/Irritation: Causes serious eye irritation
Respiratory Sensitization: Data not available
Skin Sensitization: Not a sensitizer in animal studies
Repeated Dose Toxicity: Bone and kidney effects reported at high doses
Mutagenicity: Not mutagenic based on Ames test
Carcinogenicity: Not classified as carcinogenic
Reproductive Toxicity: No evidence of reproductive effects at therapeutic doses
Target Organs: Bone, kidney (in long-term exposure)

Ecological Information

Ecotoxicity: Low hazard to aquatic life based on available data
Persistence/Degradability: May degrade slowly in the environment
Bioaccumulative Potential: Not expected to bioaccumulate (high water solubility, low log Kow)
Mobility in Soil: High mobility, likely to leach through soil
Other Adverse Effects: No major environmental impact reported at permitted use levels

Disposal Considerations

Waste Treatment Methods: Dispose in accordance with local, state, and federal regulations
Product Disposal: Collect up residual product, incinerate with chemical waste if possible
Contaminated Packaging: Rinse and render packaging unusable before recycling or landfill
Recommended Disposal Practices: Avoid release into the environment

Transport Information

UN Number: Not regulated as a hazardous material in transport
UN Proper Shipping Name: Not applicable
Transport Hazard Class: Not classified as dangerous good
Packing Group: Not assigned
Environmental Hazards: No
Special Precautions for Transport: Keep dry and protected from breakage during transport process

Regulatory Information

Labeling According to Regulation (EC) No 1272/2008: Eye Irritant Category 2
Inventory Listings: Listed on relevant national inventories (TSCA, EINECS, DSL, etc.)
SARA Title III (US): Not listed as hazardous
WHMIS (Canada): Not controlled
OSHA (US): Not hazardous as defined in 29 CFR 1910.1200
Other Information: No restriction for pharmaceutical or certified laboratory use by qualified personnel