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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
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