Material Safety Data Sheet
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ATTENTION !
USP Reference Standards are sold for chemical test and assay purposes only, and NOT for human consumption. The information contained herein is
applicable solely to the chemical substance when used as a USP Reference Standard and does not necessarily relate to any other use of the substance
described, (i.e. at different concentrations, in drug dosage forms, or in bulk quantities). USP Reference Standards are intended for use by persons having
technical skill and at their own discretion and risk. This information has been developed by USP staff from sources considered reliable but has not been
independently verified by the USP. Therefore, the USP Convention cannot guarantee the accuracy of the information in these sources nor should the
statements contained herein be considered an official expression. NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING THE
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE is made with respect to the information contained herein.
ALBUTEROL
Catalog Number: 1012600 Package Size: 200 mg June 20, 2002
Revision Date:
EMERGENCY OVERVIEW - Avoid inhalation!
SECTION 1 - IDENTIFICATION
Formula: C13H21NO3
Albuterol
Common Name:
Salbutamol
Synonym:
1,3-Benzenedimethanol, alpha1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-
Chemical Name:
18559-94-9 ZE4400000
CAS Number: RTECS Number:
Amine
Chemical Family:
Bronchodilator
Therapeutic Category:
SECTION 2 - INGREDIENT INFORMATION
Exposure Limits
Principle Components Percent
Albuterol Pure Material n/f
SECTION 3 - HEALTH HAZARD INFORMATION
The usual oral adult dose of albuterol is 2 to 6 mg three or four times a day, up to a maximum of 8 mg four
Usual Adult Dose:
times daily.
Adverse Effects: Adverse effects may include dry mouth, bitter taste, chest pain, dizziness, rapid or pounding heartbeat,
headache, nausea or vomiting, heartburn, trembling, anxiety, nervousness or restlessness, visual
disturbances, difficult or painful urination, drowsiness, flushed face, increased sweating, muscle cramps,
and weakness. Possible allergic reaction to material if inhaled, ingested or in contact with skin.
Overdose Effects: Overdose effects include severely increased blood pressure, electrolyte imbalance, central nervous system
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Copyright ?2003 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found
ALBUTEROL
Catalog Number: 1012600 Package Size: 200 mg June 20, 2002
Revision Date:
stimulation, rapid heart rate, heart attack, and possibly death.
Acute: Possible eye, skin, gastrointestinal and/or respiratory tract irritation.
Chronic: Possible hypersensitization.
May cause irritation. Avoid inhalation! Extremely small amounts of this material are physiologically
Inhalation:
active. Remove to fresh air.
May cause irritation. Flush with copious quantities of water.
Eye:
May cause irritation. Flush with copious quantities of water.
Skin:
May cause irritation. Flush out mouth with water. This material is rapidly and well absorbed from the
Ingestion:
gastrointestinal tract, with a duration of action of 8 or more hours.
Medical Conditions
Hypersensitivity to material, hyperthyroidism, diabetes mellitus, serious cardiovascular disorders and
Aggravated by Exposure:
hypertension.
Persons sensitive to one sympathomimetic amine may be sensitive to this material also.
Cross Sensitivity:
Adequate and well-controlled pregnancy studies in humans have not been done. However, some animal
Pregnancy Comments:
studies at very high doses have shown that albuterol can cause adverse effects on the fetus.
C
Pregnancy Category:
SECTION 4 - FIRST AID MEASURES
Remove from exposure. Remove contaminated clothing. Persons developing serious hypersensitivity
General:
(anaphylactic) reactions must receive immediate medical attention. If person is not breathing give artificial
respiration. If breathing is difficult give oxygen. Obtain medical attention.
Treatment for overdose should be symptomatic and supportive and may include the judicious use of a
Overdose Treatment:
cardioselective-beta-receptor blocker if necessary for cardiac arrhythmias; however, the receptor blocker
should be used with caution because it could induce severe bronchospasm or an asthmatic attack. [PDR
56th ed. 2002]
SECTION 5 - TOXICOLOGICAL INFORMATION
LD50: 660 mg/kg
Oral Rat:
LD50: 2707 mg/kg
Oral Mouse:
n/f
Irritancy Data:
Respiratory tract and Cardiovascular system.
Target Organ(s):
No No No
Listed as a Carcinogen? NTP: IARC: OSHA:
In one 2-year study in rats, albuterol given orally in high doses caused a significant dose-related
Other:
increase in the incidence of benign leiomyomas of the mesovarium. Studies have shown that
other beta-antagonists also induce mesovarium tumors in rats. A
SECTION 6 - FIREFIGHTING MEASURES
n/f Upper Flammable Limit: n/f
Flash Point:
Lower Flammable Limit: n/f
n/f
Auto-Ignition Temperature:
Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials.
Extinguisher Media:
Fire and Explosion Hazards: This material is assumed to be combustible. As with all dry powders it is advisable to ground
mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity.
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Copyright ?2003 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found
ALBUTEROL
Catalog Number: 1012600 Package Size: 200 mg June 20, 2002
Revision Date:
As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing
Firefighting Procedures:
equipment and protective clothing.
SECTION 7 - PHYSICAL HAZARDS
Avoid exposure to light.
Conditions to Avoid:
Incompatibilities: n/f
Decomposition Products: When heated to decomposition material emits toxic fumes of NOx. Emits toxic fumes under fire
conditions.
No
Hazardous Polymerization?
Yes
Stable?
SECTION 8 - HANDLING / SPILL / DISPOSAL MEASURES
As a general rule, when handling USP Reference Standards avoid all contact and inhalation of dust,
Handling:
mists, and/or vapors associated with the material. Wash thoroughly after handling.
Store in tight, light-resistant container as defined in the USP-NF. This material should be handled and
Storage:
stored per label instructions to ensure product integrity.
Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up
Spill Response:
spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage
in appropriately labelled container for disposal. Wash spill site.
Dispose of waste in accordance with all applicable Federal, State and local laws.
Disposal:
SECTION 9 - EXPOSURE CONTROLS / PERSONAL PROTECTION
When working with small quantities in a well-ventilated area, respiratory protection may not be
Respiratory Protection:
required. The use of an approved dust mask is recommended.
No special ventilation requirements.
Ventilation:
Rubber
Gloves:
Safety Glasses
Eye Protection:
Protect exposed skin.
Protective Clothing:
SECTION 10 - PHYSICAL AND CHEMICAL PROPERTIES
NOTE: The data reported below is general information, and is not specific to the USP Reference Standard Lot provided!
White to almost white crystalline powder; odorless.
Appearance and Odor:
151?C (also reported as 157 - 158?C)
Melting Point:
Vapor Density: n/f
Solubility in Water: Sparingly soluble
Boiling Point: n/f Evaporation Rate: n/f
Specific Gravity: Reactivity in Water: n/f
n/f
% Volatile by Volume: n/f
n/f
Vapor Pressure:
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Copyright ?2003 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found
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