MEDHA PHARMA 5-5-35133/1, 2"! Floor,NCS Complex, Prashanthi Nagar, Kukatpally, Hyderabad 500072, Telangana State., India, Phone: +91 89854 11066 E-mail : medhapharma@amail.com MATERIAL SAFETY DATA SHEET Name ofthe snteat | SUMATRIPTAN SUCCINATE (EP) | Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION ] ‘Name of the Material ‘SUMATRIPTAN SUCCINATE (EP) Synonyms 3-{2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5- methanesulfonamidehydrozen butanetioate Company address §-5-35/33/1, 2"? Floor, NCS Complex, Prashanthi Nagar, Kukatpally, Hyderabad-500072, Telangana, India Telephone No.: +91-8985411066 E-mail : medhapharma@gmail.com Section 2— HAZARDS IDENTIFICATION Potential Acute Health Effects Potential Acute Health Effects: Hazardous in case ot estion. Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of inhalation Potential Chronic Health Potential Chronic Health Effects: Effects CARCINOGENIC EFFECTS Not available, MUTAGENIC EFFECTS Not available. TERATOGENIC EFFECTS Not available. DEVELOPMENTAL TOXICITY: Not available, Repeated or prolonged exposure is not known to aggravate me Section 3 ~ COMPOSITION, INFORMATION ON INGREDIENTS ] ‘Synonyms 3-[2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5- methanesulfonamidehydrozen butanetioate Formula CigH2N3028.CgHsO4 Molecular Weight 413.49 g/mole ‘CAS Number 103628-48-4 ‘Component [ Classification Concentration SUMATRIPTAN SUCCINATE (EP) <= 100% Page 1 of 7MEDHA PHARMA 5.5-35/33/1, 2" Floor,NCS Complex, Prashanthi Nagar, Kukatpally, Hyderabad 500072, Telangana State., India, Phone: +91 89854 11066 E-mail : medhapharma@amail.com MATERIAL SAFETY DATA SHEET. Name of the material | SUMATRIPTAN SUCCINATE (EP) z Section 4 - FIRST AID MEASURES =| In case of Inhalation: Inhalation: If fumes or combustion products are inhaled remove from contaminated area. Other measures are usually unnecessary Serious Inhalation: Not available General advice Skin Contact: In case of Skin Wash with soap and water. Cover the irritated skin with an emollient. Get ‘medical attention if irritation develops. In case of Eye contact: Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. Warm water must be used. Get medical attention if irritation occurs. Incase of Ingestion or Ingestion: DO NOT induce vomiting unless directed to do so by medical Swallowed : personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Serious Ingestion: Not available [ Section 5 - FIRE FIGHTING MEASURES Flammability of the Product _ May be combustible at high temperature. Products of Combustion Carbon monoxide (CO), carbon dioxide (CO2), hydrogen fluoride, nitrogen oxides (NO), sulfur oxides (SO), other pyrolysis products typical of burning organic material. May emit poisonous fumes. Fire Hazards in Presence of Combustible solid which burns but propagates flame with difficulty. Avoid Various Substances generating dust, particularly clouds of dust in a confined or unventilated space as dusts may form an explosive mixture with air, and any source of ignition, ie. flame or spark, will cause fire or explosion Explosion Hazards in Risks of explosion of the product in presence of mechanical impact: Not Presence of Various available. ‘Substances Risks of explosion of the product in presence of static discharge: Not available. Fire Fighting Media and ‘Alert Emergency Responders and tell them location and nature of hazard. Wear Instructions breathing apparatus plus protective gloves. Prevent, by any means available, spillage from entering drains or water course. Use water delivered as a fine spray to control fire and cool adjacent area, DO NOT approach containers suspected to be hot, Cool fire exposed containers with Page 2 of 7MEDHA PHARMA 5-5-35/33/1, 2" Floor,NCS Complex, Prashanthi Nagar, Kukatpally, Hyderabad 500072, Special Remarks on Fire Hazards ‘Telangana State., India, Phone: +91 89854 11066 E-mail ; medhapharm: MATERIAL SAFETY DATA SHEET. ‘Name of the material | SUMATRIPTAN SUCCINATE (EP) | “water spray from a protected location. If safe to do so, remove containers from path of fire. Equipment should be thoroughly decontaminated after use. ‘As with most organic solids, fire is possible at elevated temperatures ‘Small Spill Large Spill Section 6-ACCIDENTAL RELEASE MEASURES ‘Remove all ignition sources. Clean up all spills immediately. ‘Avoid contact with skin and eyes. Control personal contact by using protective equipment. Use dry clean up procedures and avoid generating dust. Place in a suitable, labeled container for waste disposal. CAUTION: Advise personnel in area. ‘Alert Emergency Responders and tell them location and nature of hazard. Control personal contact by wearing protective clothing. Pievent, by any means available, spillage from entering drains or water courses. Recover product wherever possible. IF DRY: Use dry clean up procedures and avoid generating dust, Collect residues and place in sealed plastic bags or other Containers for disposal. IF WET: Vacuum/shovel up and place in labeled containers for disposal. E Section 7- HANDLING AND STORAGE 4 Precautions for safe handling: Conditions for safe storage, including any incompatibilities: When handling, DO NOT eats, drink or smoke. Keep containers securely sealed when not in use. ‘Avoid physical damage to containers. Always wash hands with soap and water after handling, Work clothes should be laundered separately. Use good occupational work practice. Observe manufacturer's storing and handling recommendations. Atmosphere should be regularly checked against established exposure standards to ensure safe working conditions are maintained. Empty containers may contain residual dust which has the potential to accumulate following settling. Do NOT cut, drill, grind or weld such containers, Store in original containers. Keep containers securely sealed. Store in a cool, dry, well-ventilated area. Store away from incompatible materials and foodstuff containers. Protect containers against physical damage Page 3 of 7MEDHA PHARMA §-5-35/33/1, 2” Floor,NCS Complex, Prashanthi Nagar, Kukatpally, Hyderabad 500072, Telangana State., India, Phone: +91 89854 11066 E-mail : medhapharma@gmail.com MATERIAL SAFETY DATA SHEET ‘Name of the material [sumareirran SUCCINATE (EP) ] ‘and check regularly for leaks. Observe manufacturer's storing and handling recommendations. Specific end use(s) No data available. Scetion 8 EXPOSURE CONTROLS/PERSONAL PROTECTION ] ‘Control parameters: Components with workplace. No data available control parameters Exposure controls: Engineering controls Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit. Personal Protection Safety glasses, Lab coat, Dust respirator (Be sure to use an approved/certified respirator or equivalent.), Gloves a-Eye/face protection Face shield and safety glasses use equipments for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN. 166(EU). Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. Body Protection Complete suit protecting against chemicals. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Respiratory Protection Where tisk assessment shows air — purifying respirators are appropriate use a full-face particle respirator type N100 (US) or type P3 (EN143) respirator cartridges as a backup to engineering controls If the respirator is the sole means of protection, use a full-face air respirator Personal Protection in Case Splash goggles, Full suit, Dust respirator, Boots, Gloves. A self contained Page 4 of 7MEDHA PHARMA §-5-35133/1, 2" Floor,NCS Complex, Prashanthi Nagar, Kukatpally, Hyderabad 500072, Telangana State., India, Phone: +91 89854 11086 E-mail : medhapharma@amail.com MATERIAL SAFETY DATA SHEET. ‘Name of the material | SUMATRIPTAN SUCCINATE (EP) ‘ofa Large Spill breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Section 9 - PHYSICAL AND CHEMICAL PROPERTIES Information on basic physical and chemical properties: Physical states: ‘A white or almost white powder Solubility Soluble in water Odor threshold: ‘No data available pH: 45-53 Melting/freezing poi 165 - 166°C Boiling point/range: Nordata available Flash point: No data available Evaporation rate: No data available Flammability (solid, gas): No data available Upper/lower flammability or pedals No data available explosive limits: Vapor pressure: No data available Vapor density: No data available Relative density: ‘No data available Water solubi No data available Partition coefficient: No data available ‘Auto-ignition temperature: No data available Decomposition temperature: No data available Viscosity: No data available Explosive properties: No data avaitable Oxidizing properties: No data available Other safety information No data available. Section 10 - STABILITY AND REACTIVITY. ‘Chemical stability ‘Stable under recommended storage condi Page 5 of 75-6-36/33/1, 2" Floor,NCS Complex, Prashant! MEDHA PHARMA Nagar, Kukatpally, Hyderabad 500072, Telangana State., India, Phone: +91 89854 11066 E-mail : medhapharma@qmail.com MATERIAL SAFETY DATA SHEET. [Name of the material SUMATRIPTAN SUCCINATE (EP) Reactivity ‘Not available. Possibi of hazardous Not available. reactions Conditions to avoid Not available. Incompatible materials ‘No data available Hazardous decomposition No data available products Section 11 - TOXICOLOGICAL INFORMATION Information on toxicological effects Routes of Entry Inhalation, Ingestion Other Toxic Effects on Hazardous in case of ingestion. Slightly hazardous in case of skin contact, Humans (irritant), of inhalation Special Remarks on other _Acute Potential Health Effects: Toxicity data (LD50) Oral LD50 (rat): >2939 mg/kg; Subcutaneous LDS0 (rat): 1680 mg/kg; Oral TDLO (woman): 2 mg/kg: Toxic Effeets on Humans Skin: May cause skin irritation. Eyes: Causes eye burns Inhalation: May cause respiratory tract i Ingestion: May be harmful if swallowed ‘Section 12 ECOLOGICAL INFORMATION Toxicity Products of Biodegradation Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Conducted Toxicity of the Products of The products of degradation are as toxic as the product itself. Biodegradation Bioaccumulative potential _ No data available Mobility in soi No data available No data available Other adverse effects No data available Section 13 -DISPOSAL CONSIDERATIONS, 2 = os Waste disposal methods ‘All waste must be handled in accordance with local, state and federal Page 6 of 7MEDHA PHARMA 5-5-35/33/1, 2” Floor,NCS Complex, Prashanthi Nagar, Kukatpally, Hyderabad 500072, Telangana State., India, Phone: +91 89854 11066 E-mail : medhapharma@qmail.com MATERIAL SAFETY DATA SHEET. UMATRIPTAN SUCCINATE (EP) regulations Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to laws Operating in their area, In some areas, certain wastes must be tracked. Ee Section 14- TRANSPORT INFORMATION DOT ‘Not regulated for transport of dangerous goods: DOT, IATA, IMDG IMDG No data available IATA Not regulated as per IATA, Section 15- REGULATORY INFORMATION Safety, health and enviromental regulations/legislation specific for the substance or mixture (This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.) Federal and State Regulations _: As per the local body Federal and State Regulations to be referred Other Classifications : Protective Equipment: Gloves. Lab coat. Dust respirator. Be sure to use an approved / certified respirator or equivalent. Safety glasses [ ‘Section 16 - OTHER INFORMATION ] The above information is believed to be correct but does not purport to be all inclusive and shall be used only as ‘a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions, It does not represent any guarantee of the properties of the product. Azakem labs Pvt Ltd and Its affiliates Shall not be held liable for any damage resulting from handling or from contact with the above product. Page 7 of 7