Pirfenidone Tablets 801mg

SECTION 2: Hazards identification

Directive 67/548/EEC: CLASSIFICATION OF THE SUBSTANCE OR MIXTURE

2.3 Other hazards

This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

2.1 Classification of the substance or mixture

Percent 53179-13-8 Pirfenidone 95.0 - 105.0 None assigned Mannitol (Pearlitol SD 200) 5.2 9004-34-6 Microcrystalline cellulose (Pharmacel 101) 5.6 74811-65-7 Croscarmellose sodium (AcDiSol-SD-711) 2.1 9003-39-8 Povidone (Plasdone K-29/32) 3.6 112945-52-5, 7631-86-9 Colloidal Silicon Dioxide (Aerosil 200) 0.3 4070-80-8 Sodium steryl fumarate 0.6 None Assigned Opadry II 85F500083 Purple 2.8 SECTION 4: FIRST AID MEASURES 4.1 DESCRIPTION OF NECESSARY FIRST-AID MEASURES: 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. Get medical attention immediately. Skin contact: In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient / Remove contaminated clothing and shoes. Cold water may be used. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention. Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately / Loosen tight clothing such as a collar, tie, belt or waistband. 4.2 MOST IMPORTANT SYMPTOMS/ EFFECTS - ACUTE AND DELAYED: No data available. 4.3 INDICATION OF IMMEDIATE MEDICAL ATTENTION AND SPECIAL TREATMENT NEEDED: Treat symptomatically. SECTION 5: FIREFIGHTING MEASURES 5.1 EXTINGUISHING MEDIA: Suitable extinguishing media: Water,Foam (Alcohol resistant AFFF),ABC Powder,Carbon Dioxide,Dry Sand,DCP (Dry Chemical Powder) Unsuitable extinguishing media: For this substance/ mixture no limitations of extinguishing agents are given. 5.2 SPECIFIC HAZARDS ARISING FROM THE SUBSTANCE OR MIXTURE: Carbon Oxides. 5.3 ADVICE FOR FIRE FIGHTERS: Wear self contained breathing apparatus for firefighting if necessary. SECTION 6: ACCIDENTAL RELEASE MEASURES 6.1 PERSONAL PRECAUTIONS PROTECTIVE EQUIPMENT AND EMERGENCY PROCEDURES: Wear respiratory protection. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. 6.2 ENVIRONMENTAL PRECAUTIONS: Ensure adequate ventilation. Use personal protective equipment. Avoid dust formation. Keep people away from and upwind of spill/leak. Evacuate personnel to safe areas. 6.3 METHODS AND MATERIALS FOR CONTAINMENT AND CLEANING UP: Do not flush into surface water or sanitary sewer system. Do not allow material to contaminate ground water system. SECTION 7: HANDLING AND STORAGE 7.1 PRECAUTIONS FOR SAFE HANDLING: During handling wear personal protective equipment. Ensure adequate ventilation. Avoid contact with skin, eyes and clothing. Avoid ingestion and inhalation. 7.2 CONDITIONS FOR SAFE STORAGE, INCLUDING ANY INCOMPATIBILITIES: Store at 25°C (77°F) ; excursions permitted to 15 -30°C (59-86°F). SECTION 8: EXPOSURE CONTROLS/ PERSONAL PROTECTION 8.1 CONTROL PARAMETERS: No Data available 8.2 EXPOSURE CONTROLS: Appropriate Engineering Controls: Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and the end of workday. 8.3 PERSONAL PROTECTIVE EQUIPMENT : Eye & Face protection: Use personal protective equipment such as Nose mask, goggles & gloves as described by the Indian standard and/or international standard. Skin & Body protection: Long sleeved clothing. Gloves must be inspected prior to use. Respiratory protection: Required when dusts are generated. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES 9.1 INFORMATION ON BASIC PHYSICAL AND CHEMICAL PROPERTIES: Physical state & Appearance : Tablet : Brown Colored, Oval shaped, biconvex Film- coated tablets debossed with "LP8' on one side Colour and plain on other side and free from physical defects. Odor : No data available Odour threshold : No data available pH : No data available Melting point/freezing point : No data available Boiling point / range : No data available Flash point : No data available Flammability (solid, gas) : No data available Flammability or explosive limits - Upper : No data available Flammability or explosive limits - Lower : No data available Evaporation rate : No data available Vapour pressure : No data available Vapour density : No data available Relative density : No data available Water solubility : No data available Partition coefficient: n-octanol/water : No data available Auto-ignition temperature : No data available Decomposition temperature : No data available Special gravity : No data available. Oxidizing properties : No data available Viscosity : Not applicable SECTION 10: STABILITY AND REACTIVITY 10.1 REACTIVITY: No data available. 10.2 CHEMICAL STABILITY: Stable under recommended storage conditions. 10.3 POSSIBILITY OF HAZARDOUS REACTIONS: No data available. 10.4 CONDITIONS TO AVOID: Heat, Flames and Sparks. Extremes of temperature and direct sunlight. 10.5 INCOMPATIBLE MATERIALS: No data available. 10.6 HAZARDOUS DECOMPOSITION PRODUCTS: Carbon oxides. SECTION 11: TOXICOLOGICAL INFORMATION 11.1 INFORMATION ON TOXICOLOGICAL EFFECTS: Acute Toxicity: Type Species Value Unit Any other LD50, Oral Rat > 2000 mg/kg -- Skin corrosion/irritation: No data available. Serious eye damage/eye irritation: No data available. Respiratory or skin sensitization: No data available. Germ cell mutagenicity: No data available. Carcinogenicity: IARC: No component of this product presents at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC. To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. Reproductive toxicity: No data available. Specific target organ toxicity - single exposure: No data available. Specific target organ toxicity - repeated exposure: No data available. Aspiration hazard: No data available. 11.2 ADDITIONAL INFORMATION: The toxicological properties have not been fully investigated. SECTION 12: ECOLOGICAL INFORMATION 12.1 ECO-TOXICITY: Do not allow product to enter drinking water supplies, waste water or soil. Toxicity to algae: No data available. 12.2 PERSISTENCE AND DEGRADABILITY: Biodegradability: No data available. 12.3 BIOACCUMULATIVE POTENTIAL: No data available. 12.4 MOBILITY IN SOIL: No data available. 12.5 OTHER ADVERSE EFFECTS: No data available. SECTION 13: DISPOSAL CONSIDERATIONS Waste Disposal methods -Waste must be segregated, stored and disposed of in accordance with central, state and local environmental control regulations. SECTION 14: TRANSPORT INFORMATION TRANSPORT ADR/RID IMDG IATA 14.1 UN NUMBER -- Not a dangerous 14.2 UN PROPER SHIPPING NAME Not a dangerous goods 14.3 TRANSPORT HAZARD -- CLASS(ES) 14.4 PACKING GROUP -- 14.5 ENVIRONMENTAL HAZARD No 14.6 SPECIAL PRECAUTIONS FOR -- USER 14.7 SYMBOL -- SECTION 15: REGULATORY INFORMATION Safety, health and environmental regulations specific for the substance or mixture This safety datasheet complies with the requirements of Regulation (EC) No. 1272/2008. SECTION 16: OTHER INFORMATION DISCLAIMER: 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. Revision log: Revision No. Reason for Revision Effective Date 0.0 First Issue 30 Jan 2018 1.0 Template is changed and Sections - 9 modified. 08 Apr 2022 Prepared By: Reviewed By: Shilpa. S Bipin Kumar. S (6519) (6186) END OF SAFETY DATA SHEET ----- This is an electronically generated SDS, and hence need not be signed -----