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MATERIAL SAFETY DATA SHEET SECTION 1 - PRODUCT & COMPANY IDENTIFICATION 1501 East Woodfield Road Suite 300 East Schaumburg, IL 60173 (847) 969-2700 Emergency Telephone: (800) 551-7176 Product Identifier: Chloramphenicol Sodium Succinate for Injection, USP Chemical Name: Chloramphenicol Sodium Succinate Category: Anti-Infective SECTION 2 - COMPOSITION/INFORMATION ON INGREDIENTS Ingredient CAS Number Amount Chloramphenicol Sodium Succinate 982-57-0 1 gm vials SECTION 3 - HAZARDS IDENTIFICATION Route of Entry: Inhalation, eye/skin contact, or ingestion Chemical Listing as Carcinogen NTP: No IARC: No OSHA: No Note: NA SECTION 4 - EMERGENCY & FIRST AID MEASURES Eyes: Immediately flush eyes with water for at least 15 minutes. Seek medical attention. Skin: Remove contaminated clothing immediately. Flush area with water for at least 15 minutes. Wash exposed area with soap and water. Seek medical attention if pain, redness, or swelling persists. Inhalation: Move exposed subject to fresh air immediately. Give artificial respiration and cardiopulmonary resuscitation (CPR) if required. Seek medical attention. Ingestion: Flush mouth out with water immediately. Seek medical attention. Contact Info: For Adverse Event Information, please call (800) 551-7176 or (847) 969-2700. Note: This is an empty field. American Pharmaceutical Partners, Inc. Chloramphenicol Sodium Succinate for Injection, USP Page 1 of 5 Revision date: 08/25/05, Version: 1.0.0 SECTION 5 - FIRE FIGHTING MEASURES Fire and Explosion Data Closed Cup Flash Point: NE Open Cup Flash Point: NE Fire Point: NE Autoignition: NE Lower Explosion Limit: NE Upper Explosion Limit: NE General Hazard: When heated to decomposition, toxic fumes may be emitted. Fire Fighting Instructions: Water spray, dry chemical, carbon dioxide, or foam as appropriate to surroundings. Fire Fighting Equipment: Wear self-containing breathing apparatus and protective clothing. Hazardous Combustion Products: Toxic fumes of chloride, NOX, and Na2O. SECTION 6 - ACCIDENTAL RELEASE MEASURES Clean-Up: Wear recommended personal protective equipment (See Section 8 - Exposure Controls/Personal Protection). Use absorbent towels or brooms to clean-up spill. Wipe surface area clean with soap and water. SECTION 7 - HANDLING AND STORAGE General Handling: When handling pharmaceutical products, avoid all contact and inhalation of dust, fumes, mist, and/or vapors associated with the product. Storage Conditions: Store at controlled room temperature 15°-30°C (59°-86°F). SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION Engineering Controls: General room ventilation is usually satisfactory. Use local exhaust ventilation if necessary. Personal Protective Equipment: American Pharmaceutical Partners, Inc. Chloramphenicol Sodium Succinate for Injection, USP Page 2 of 5 Revision date: 08/25/05, Version: 1.0.0 SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION…continued Eye Protection: Safety glasses or goggles recommended. Hand Protection: Disposable latex gloves recommended. Respiratory Protection: With satisfactory ventilation, respiratory protection is usually not required. Skin Protection: Disposable garments if direct skin contact is anticipated. Exposure Limits: Compound Issuer Type OEL Chloramphenicol Sodium Succinate OSHA PEL NE ACGIH TLV NE --- STEL NE SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES Physical Form/ Appearance: Yellowish-white lyophilized powder, odorless. Boiling Point/Boiling Range: NA (powder) Melting Point/Melting Range: 151°C Freezing Point: NA Vapor Pressure : NE Relative Vapor Density: NE Percent Volatiles: NE pH: 6.4 - 7.0 Molecular Weight: 445.21 Solvent Solubility: Slightly water soluble (2.5 mg/mL) Note: NA SECTION 10 - STABILITY AND REACTIVITY Stability: Stable Conditions to Avoid: Excessive heat greater than 40°C (104°F). Hazardous Polymerization: Will not occur American Pharmaceutical Partners, Inc. Chloramphenicol Sodium Succinate for Injection, USP Page 3 of 5 Revision date: 08/25/05, Version: 1.0.0 SECTION 11 - TOXICOLOGY INFORMATION Signs & Symptoms of Exposure & Overexposure: This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert. Adverse reactions from therapeutic doses include: bone marrow suppression, aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia are the most serious adverse events. Nausea, vomiting, glossitis, stomatitis, diarrhea, enterocolitis, headache, mild depression, mental confusion, delirium, fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis have been reported. Occupational exposure has not been fully investigated. Medical Conditions Aggravated by Accidental Exposure: Individuals with a history of previous hypersensitivity and/or toxic reactions to chloramphenicol. Acute Toxicity: Compound Type Route Species Dosage Chloramphenicol Sodium Succinate LD50 IV Rat 1500 mg/kg Other: IMMEDIATE EFFECTS: Eye, skin, and respiratory irritation may occur. DELAYED EFFECTS: Hypersensitivity reactions ranging from mild to life-threatening may occur. SECTION 12 - TRANSPORTATION INFORMATION UN/NA Number: NA U.S. DOT Hazard Class: NA Proper Shipping Name: NA Shipping Label: NA SECTION 13 - DISPOSAL INFORMATION Disposal Procedure s: Treatment, storage, transportation, and disposal must be in accordance with applicable federal, state, and local regulations. American Pharmaceutical Partners, Inc. Chloramphenicol Sodium Succinate for Injection, USP Page 4 of 5 Revision date: 08/25/05, Version: 1.0.0 SECTION 14 - OTHER Key to Abbreviations: ACGIH - American Conference of Governmental Industrial Hygienists HEPA - High Efficiency Particulate Air IARC - International Agency for Research on Cancer NA - Not Applicable NE - Not Established NG - Not Given NIOSH - National Institute for Occupational Safety and Health NTP - National Toxicology Program OEL - Occupational Exposure Limit OSHA - Occupational Safety and Health Administration PEL - Permissible Exposure Limit PPM - Parts Per Million QS - Quantity Sufficient RCRA - Resource Conservation and Recovery Act STEL - Short Term Exposure Limit TLV - Threshold Limit Value USP - United States Pharmacopeia Disclaimer: The information contained herein pertains to this material. It is the responsibility of each individual party to determine for themselves the proper means of handling and using these materials based on their purpose and intended use. American Pharmaceutical Partners, Inc. assumes no liability resulting from the use of or reliance upon the information contained in this material safety data sheet. This material safety data sheet does not constitute the guaranty or specifications of the product. American Pharmaceutical Partners, Inc. Chloramphenicol Sodium Succinate for Injection, USP Page 5 of 5 Revision date: 08/25/05, Version: 1.0.0