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Ipratropium Bromide, 0.5 mg/ Albuterol Sulfate, 3.0 mg Inhalation Solution, USP

Effective Date: 10-17-2007

Nephron Pharmaceuticals Corporation

4121 34th Street Orlando, FL 32811-6458

(407) 246-1389 (321) 388-7024

(24 hour contact)

Effective Date: 10-17-2007


SECTION 1: CHEMICAL SUBSTANCE PRODUCT NAME: GENERIC NAME: CHEMICAL NAME: Ipratropium Bromide, 0.5 mg/ Albuterol Sulfate, 3.0 mg Inhalation Solution, USP Ipratropium Bromide/ Albuterol Sulfate Ipratropium Bromide: 8-azoniabicyclo [3, 2, 1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1methylethyl)-, bromide (endo, syn)-, (±)-, monohydrate Albuterol Sulfate: '- [tert-butylamino-methyl] -4-hydroxy-m-xilene--'-diol sulfate (2:1) (salt) MOLECULAR FORMULA: MOLECULAR WEIGHT: PRODUCT USE: CAS NUMBER: C20H30BrNO3/ C26H42N2O6·H2SO4 430.4/ 576.71 Bronchodilator 66985-17-9/ 51022-70-9 SECTION 2: COMPONENTS PER UNIT DOSE MATERIAL: Active Ingredients: Ipratropium Bromide Albuterol Sulfate Excipients: Sodium Chloride Purified Water, USP EXPOSURE LIMITS 3 PEL (mg/m ) not established not established

TVL (µg/m ) 2 10


% Content 100% 100%

not established not established

not established not established

1 N/A

SECTION 3: HAZARDS IDENTIFICATION ROUTE OF ENTRY: Inhalation, ingestion, eyes/skin contact. TARGET ORGANS: Liver, GI tract, adrenals, male reproductive organs and eyes. POTENTIAL HEALTH HAZARDS Contraindications: Although rare, this product can cause immediate hypersensitivity in patient. Therefore, this product should not be used by patients who have had a previous allergic reaction to ipratropium bromide, albuterol sulfate or its derivatives. Carcinogenicity: (NTP) No (IARC) No (OSHA) No

Chronic Effects: Possible hypersensitization (development of abnormal sensitivity).

Material Safety Data Sheet Page 1 of 4 Nephron Pharmaceuticals Corporation

Ipratropium Bromide, 0.5 mg/ Albuterol Sulfate, 3.0 mg Inhalation Solution, USP

Effective Date: 10-17-2007

SECTION 4: FIRST AID MEASURES Eye: Remove contact lenses if necessary. Flush eyes with large amounts of running water for at least 15 minutes. Seek medical attention if blurred vision or sensitivity to light occurs. Skin: Removed contaminated clothing. Flush affected area with copious amounts of soap and water. If irritation or rash develops, get medical attention. Ingestion: Move affected person to a well-ventilated area and get immediate medical attention. If breathing becomes difficult, give oxygen. If breathing stops, give artificial respiration. Inhalation: May cause irritation and hypersensitivity (anaphylactic) in some individuals. Inhalation of a liquid preparation is not likely. Evaporation is minimal at controlled room temperatures. Medical Conditions Aggravated by Exposure: Hypersensitivity to any of the product components, narrow angle glaucoma, prostatic hypertrophy, bladder neck obstruction, hepatic (liver) or renal (kidney) dysfunction. Additional details are available on the package insert or in the Physician Desk Reference. SECTION 5: FIRE/EXPLOSION HAZARDS & FIRE-FIGHTING MEASURES FLAMABLE PROPERTIES: HAZARDOUS PRODUCTS: EXTINNGUISHING MEDIA: FIRE-FIGHTING PROCEDURES: Flash point: N/A N/A N/A N/A SECTION 6: SPILL AND LEAK PROCEDURES SPILL RESPONSE PROCEDURES (Liquid, Solid, Gas/Vapor): Wear approved personal protective equipment for spills, (See Section 8, "Exposure Controls / Personal Protection" for guidance). Large/Small Spills: Use absorbent towels or brooms to clean-up spill. Wipe surface area clean. SECTION 7: HANDLING AND STORAGE HANDLING: When handling avoid all contact with eyes, skin or clothing. Avoid inhalation of dust, fumes, mist and/or vapors associated with the product. STORAGE: Store in airtight container. Protect from light and extreme heat. SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION ENGINEERING CONTROLS: General room ventilation is satisfactory. PERSONAL PROTECTION: Respiratory: Eye: Skin:

Material Safety Data Sheet

Method: N/A

Respiratory protection not required. Goggles or chemical safety glasses are recommended. Latex rubber gloves recommended. Protective clothing is not required.

Page 2 of 4 Nephron Pharmaceuticals Corporation

Ipratropium Bromide, 0.5 mg/ Albuterol Sulfate, 3.0 mg Inhalation Solution, USP Other: Ventilation: Eye wash.

Effective Date: 10-17-2007

General room ventilation is satisfactory. If general ventilation is not sufficient, local exhaust is recommended. SECTION 9: PHYSICAL / CHEMICAL PROPERTIES

Appearance & Odor: Physical State: Boiling Point: Specific Gravity: Water Solubility:

Clear, aqueous solution with a little or no odor. Evaporation Rate: Vapor Density: Viscosity: not established not established not established

Liquid. not established 1.0067 Soluble

Percent Volatile by Volume: not established SECTION 10 STABILITY AND REACTIVITY


Stable. No conditions contributing to instability are known to exist. When heated to decomposition or under fire conditions, solution may emit toxic fumes. Will not occur. SECTION 11 TOXICOLOGICAL INFORMATION



This product is intended for therapeutic uses only when prescribe by a physician. Potential adverse reactions from prescribed doses and overdoses are described in package insert. Occupational exposure has not been fully investigated. SECTION 12 ECOLOGICAL INFORMATION

CHEMICAL FATE INFORMATION: Product administered to patients presents a negligible impact on the environment. SECTION 13 WASTE DISPOSAL Dispose Procedures: Treatment, storage, transportation, and disposal of material must be in accordance with applicable Federal, State, and Local regulations. EPA Designation: RCRA Hazardous Waste: Not Listed SARA Title III: Not Listed

Material Safety Data Sheet

Page 3 of 4

Nephron Pharmaceuticals Corporation

Ipratropium Bromide, 0.5 mg/ Albuterol Sulfate, 3.0 mg Inhalation Solution, USP

Effective Date: 10-17-2007

SECTION 14 TRANSPORTATION INFORMATION US Department of Transportation (DOT) Proper Shipping Name: IATA/ICAO Proper Shipping Name: IMDG Proper Shipping Name: RQ: None

Not Regulated

Not Regulated Not Regulated Marine Pollutant: No SECTION 15 REGULATORY INFORMATION


Not applicable. Not determined.

SECTION 16 OTHER INFORMATION We believe that the information contained within this MSDS is current as of the date issued. Since the use of this information and these opinions and the conditions of use of this material are not within the control of Nephron Pharmaceuticals Corporation, it is the user's obligation to determine the conditions of safe use of this material. Nephron Pharmaceuticals Corporation urges the users of this product to study this MSDS and become aware of any hazards associated with this material. In the interest of safety, the information contained in this MSDS should be made available to your employees, agents and contractors who handle this material.


Material Safety Data Sheet

Page 4 of 4

Nephron Pharmaceuticals Corporation


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