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MATERIAL SAFETY DATA SHEET

1. Product and Company Identification

Material name Diluted Isosorbide Dinitrate

Catalog number 1353000

Version # 02

Revision date 02-14-2012

CAS # Mixture

Manufacturer information U. S. Pharmacopeia12601 Twinbrook ParkwayRockville, MD 20852-1790RS Technical Services 301-816-8129

2. Hazards Identification

Emergency overview Flammable. Irritant.This product, as supplied, is not an explosive. However, undiluted isosorbide dinitrate is exploby percussion or excessive heat. Any separation of it from the diluent in this mixture, even in samounts, is extremely hazardous.

OSHA regulatory status This product is considered hazardous under 29 CFR 1910.1200 (Hazard Communication).

Potential health effects

Eyes Dust in the eyes will cause irritation. Avoid contact with eyes.

Skin Irritating to skin. Dust or powder may irritate the skin. Avoid contact with the skin.

Inhalation Dust may irritate respiratory system.

Ingestion Harmful if swallowed. May cause irritation. Do not ingest.

Signs and symptoms Irritating to mouth, throat, and stomach.

Components CAS # Percent

3. Composition / Information on Ingredients

63-42-3 60 - 80Anhydrous Lactose

87-33-2 20 - 40Isosorbide Dinitrate

4. First Aid Measures

First aid procedures

Eye contact May cause irritation. Flush with copious quantities of water.

Skin contact May cause irritation. Flush with copious quantities of water. Isosorbide dinitrate is absorbed frothe skin.

Inhalation May cause irritation. Remove to fresh air.

Ingestion May cause irritation. Flush out mouth with water. Isosorbide dinitrate is readily absorbed from oral mucosa and well absorbed from the gastrointestinal tract.

Notes to physician Treatment of nitrate overdose should be symptomatic and supportive and may include thfollowing:

1. Administer activated charcoal as a slurry. The benefit of activated charcoal following a largeoral ingestion is unknown.2. For hypotension, infuse isotonic fluid. If hypotension persists, administer dopamine ornorepinephrine.3. For methemoglobinemia, slowly administer intravenous methylene blue in symptomaticpatients. Additional doses may be required. [Meditext 2006]

General advice Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance fan occupational health physician or other licensed health-care provider familiar with workplacechemical exposures. In the United States, the national poison control center phone number is1-800-222-1222. If person is not breathing, give artificial respiration. If breathing is difficult, goxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions mustreceive immediate medical attention.

Material name: Diluted Isosorbide Dinitrate

MSDS No. 1353000 Version #: 02 Revision date: 02-14-2012 Print date: 02-14-2012

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Hand protection Chemically compatible gloves. For handling solutions, ensure that the glove material is protectiagainst the solvent being used. Use handling practices that minimize direct hand contact.Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlgloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy.

Skin protection For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significantquantities are handled, work clothing may be necessary to prevent take-home contamination.

Respiratory protection Where respirators are deemed necessary to reduce or control occupational exposures, useNIOSH-approved respiratory protection and have an effective respirator program in place(applicable U.S. regulation OSHA 29 CFR 1910.134).

General hygieneconsiderations

Do not breathe dust. Avoid contact with eyes. Avoid contact with skin. Wash hands after handland before eating. Handle in accordance with good industrial hygiene and safety practice.

9. Physical & Chemical Properties

Physical state Solid.

Appearance Ivory-white powder.

Form Powder.

Odor Odorless.

Odor threshold Not available.

pH Not available.

Vapor density Not available.

Boiling point Not available.

Specific gravity Not available.Relative density Not available.

Flash point Not available.

Flammability limits in air,upper, % by volume

Not available.

Flammability limits in air,lower, % by volume

Not available.

Auto-ignition temperature Not available.

10. Chemical Stability & Reactivity Information

Chemical stability Risk of ignition. Stable at normal conditions.

Conditions to avoid Heat, flames and sparks.

Incompatible materials Water, acids, alkalis, and oxidizing agents.

Hazardous decompositionproducts

When heated to decomposition, material emits toxic fumes of NOx. Emits toxic fumes under fconditions.

Possibility of hazardousreactions

Hazardous polymerization does not occur.

11. Toxicological Information

Effects of exposure Overdose effects of isosorbide dinitrate include bluish-colored lips, fingernails, or palms of handflushed or cold and clammy skin; extreme dizziness or fainting; feeling of extreme pressure inhead; shortness of breath; unusual tiredness or weakness; weak or fast heartbeat; fever;convulsions; heart block; paralysis; coma; and death.

Toxicological data

Components Test Results

Acute Dermal LD50 Rat: < 3 g/kgIsosorbide Dinitrate (87-33-2)

Acute Oral LD50 Mouse: 1050 mg/kg

Acute Oral LD50 Rat: 747 mg/kg

Medical condtionsaggravated by exposure

Hypersensitivity to material, active alcoholism, gastric hypermobility, heart problems, hypotensanemia, hyperthyroidism, cerebral hemorrhage or recent head trauma, and glaucoma.

Cross sensitivity Persons sensitive to one nitrate or nitrite may be sensitive to this material also.

Acute effects Possible eye, skin, gastrointestinal, and/or respiratory tract irritation.

Chronic effects Possible hypersensitization. Dependence or tolerance may occur with isosorbide dinitrate.



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Carcinogenicity This product is not considered to be a carcinogen by IARC, ACGIH, NTP, or OSHA.

Skin corrosion/irritation Irritating to skin.

Mutagenicity Isosorbide dinitrate was not mutagenic in the Salmonella typhimurium and E. coli tests, with orwithout activation.

Reproductive effects A modified two-litter reproduction study among rats fed isosorbide dinitrate at 25 or 100mg/kg/day revealed no evidence of altered fertility or gestation.Isosorbide has been shown to cause embryotoxicity, such as excessively dehydrated offspring,rabbits at a dose of 70 mg/kg. Rabbits given up to 10 mg/kg isosorbide dinitrate intravenouslyduring pregnancy showed no increase in birth defects.

Symptoms and target

organs

Cardiovascular system.

12. Ecological Information

Persistence anddegradability

Not available.

13. Disposal Considerations

Disposal instructions Dispose of waste in accordance with all applicable Federal, State, and local laws.

Contaminated packaging Empty containers should be taken to an approved waste handling site for recycling or disposal

14. Transport Information

IATA

Basic shipping requirements:Isosorbide Dinitrate Mixture with 60% or more of lactose (Diluted Isosorbide Dinitrate)Proper shipping name

4.1Hazard class

2907UN number

IIPacking group

DOT

Basic shipping requirements:

2907UN number

Isosorbide Dinitrate Mixture with 60% or more of lactose (Diluted Isosorbide Dinitrate)Proper shipping name

4.1Hazard class

IIPacking group

Additional information:

133ERG number

15. Regulatory Information

US federal regulations This product is a "Hazardous Chemical" as defined by the OSHA Hazard Communication Standa29 CFR 1910.1200.

All components are on the U.S. EPA TSCA Inventory List.

CERCLA/SARA Hazardous Substances - Not applicable.

CERCLA (Superfund) reportable quantity

None

Superfund Amendments and Reauthorization Act of 1986 (SARA)

Hazard categories Immediate Hazard - YesDelayed Hazard - No

Fire Hazard - YesPressure Hazard - NoReactivity Hazard - No

Section 302 extremelyhazardous substance

No

Section 311 hazardouschemical

No

Inventory status

Country(s) or region Inventory name On inventory (yes/n

Australia Australian Inventory of Chemical Substances (AICS)



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Country(s) or region Inventory name On inventory (yes/n

Canada Domestic Substances List (DSL)

Canada Non-Domestic Substances List (NDSL)

China Inventory of Existing Chemical Substances in China (IECSC)

Europe European Inventory of Existing Commercial Chemical Substances(EINECS)

Europe European List of Notified Chemical Substances (ELINCS)

Japan Inventory of Existing and New Chemical Substances (ENCS)

Korea Existing Chemicals List (ECL)

New Zealand New Zealand Inventory

Philippines Philippine Inventory of Chemicals and Chemical Substances(PICCS)

United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory

*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)

State regulations This product does not contain a chemical known to the State of California to cause cancer, birtdefects or other reproductive harm.

16. Other Information

Disclaimer USP Reference Standards are sold for chemical test and assay purposes only, and NOT for humconsumption. 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 thsubstance described, (i.e. at different concentrations, in drug dosage forms, or in bulk quantitiUSP Reference Standards are intended for use by persons having technical skill and at their owdiscretion and risk. This information has been developed by USP staff from sources consideredreliable but has not been independently verified by the USP. Therefore, the USP Convention caguarantee the accuracy of the information in these sources nor should the statements containeherein be considered an official expression. NO REPRESENTATION OR WARRANTY, EXPRESS OIMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR APARTICULAR PURPOSE is made with respect to the information contained herein.

Issue date 02-14-2012



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