Isosorbide Dinitrate

Isosorbide dinitrate is in a group of drugs called nitrates. Isosorbide dinitrate dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Isosorbide dinitrate is used to treat or prevent attacks of chest pain (angina).

Only the sublingual tablet should be used to treat an angina attack that has already begun.

Isosorbide dinitrate regular and extended-release tablets are used to prevent angina attacks but will not treat an angina attack.

Isosorbide dinitrate may also be used for purposes not listed in this medication guide.

Certificate of Analysis

  • Description

    White odourless powder..

    Result

    Complies

  • Identification by IR

    Conforms to standard (by IR)

    Result

    Complies

  • Identification by TLC

    Conforms to TLC test for ISMN

    Result

    Complies

  • Identification by Lactose Test

    Conforms to TLC test for Lactose

    Result

    Complies

  • Identification by Melting Point

    89 -91° C

    Result

    90 ° C

  • Inorganic Nitrates (By TLC)

    NMT 0.5 %

    Result

    Complies

  • Related substances (By HPLC) Isosorbide Dinitrate / Isosorbide – 2- Dinitrate

    NMT 0.5 % / NMT 0.5 %

    Result

    Individual Impurity:0.02 % / 0.00 %

  • Assay (By HPLC)

    95 to 105 % of labelled amount.

    Result

    99.5 %

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Material Safety Data Sheet

  • Section 1 – Chemical Product

    Product Identifier

    Isosorbide Dinitrate

    MSDS Prepared By

    R&D Department

  • Section 2 – Composition / Information Of Ingredients

    Product Name

    Isosorbide Dinitrate

    Molecular Formula

    C6H8N2O8

    Molecular Weight

    236.14 g/mol

    CAS Number

    87-33-2

  • Section 3 – HAZARDOUS IDENTIFICATION

    Acute Toxicity Oral (Category 4)

    H302

    Xn

    Harmful R22 / R5.

    Label according Regulations (EC) No 1272/2008

    Single Word

    Warning

    H302

    Harmful if swallowed.

    Precautionary Statement

    None

    Supplemental Hazard Statement

    None

    According to European Directive 67/548/EEC as amended.

    Hazard Symbol

    Harmful

    R-phrase(s)

    R5

    Heating may cause explosion

    R22

    Harmful if swallowed.

    S-phrase(s)

    None

    Other Hazard

    None

  • Section 4 – FIRST AID

    General Advice

    Consult a physician. Show this safety data sheet to the doctor in attendance.

    Eye Contact

    Flush eyes with water as a precaution.

    Skin Contact

    Wash off with soap and plenty of water. Consult a physician.

    Inhalation

    If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.

    Ingestion

    Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician./p>

  • Section 5 – FIRE FIGHTING MEASURES

    Suitable Extinguishing Media

    Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

    Special hazards arising from the substance or mixture

    Carbon oxides, nitrogen oxides (NOx).

    Advice for Firefighters

    Wear self-contained breathing apparatus for firefighting if necessary.

    Further Information

    N/A

  • Section 6 – ACCIDENT RELEASE MEASURES

    Personal Precaution

    Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Avoid breathing dust. For personal protection see section 8.

    Environmental Precautions

    Do not let product enter drains

    Methods & material for Containment & Cleaning up

    Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.

  • Section 7 – HANDLING AND STORAGE

    Handling

    Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed. Normal measures for preventive fire protection.

    Storage

    Store in cool place. Keep container tightly closed in a dry and well-ventilated place.

  • Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

    Engineering Controls

    Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.

    Personal Protection Equipment

    Eye Protection

    Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).

    Skin Protection

    Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove’s outer surface) to avoid skin contact with this product. Dispose of as after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

    Body Protection

    Complete suit protecting against chemicals, the type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.

    Respiratory Protection

    For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator. For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).

    Control of Environmental Exposure

    Do not let product enter drains.

  • Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

    Physical States

    Solid

    Appearance and Odor

    A crystalline solid

    Melting Point

    N/A

    Boiling Point

    N/A

    Flash Point

    N/A

    Evaporation Rate

    N/A

    Explosive Limits

    N/A

    Vapor Pressuret

    N/A

    Vapor Density

    N/A

    Relative Density

    N/A

    Solubility in Water

    N/A

    Partition Coeff

    N/A

    Auto-ignition Point

    N/A

    Decomposition Temperature

    N/A

    Viscosity

    N/A

    Explosive Properties

    N/A

    Oxidizing Properties

    N/A

  • Section 10 – STABILITY AND REACTIVITY

    Reactivity

    N/A

    Chemical Stability

    Stable under recommended storage conditions.

    Possibility of Hazardous Reactions

    N/A

    Condition to Avoid

    N/A

    Incompatibility Materials

    N/A

    Hazardous Decomposition

    N/A

  • Section 11 – TOXICOLOGICAL INFORMATION

    Acute Toxicity

    Skin Corrosion / Irritation

    N/A

    Serious Eye Damage / Eye Irritation

    N/A

    Respiratory or Skin Sensitization

    N/A

    Germ cell Mutagenicity

    N/A

    Carcinogenicity

    IARC

    No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible of confirmed human carcinogen by IARC.

    Reproductive Toxicity

    N/A

    Specific target Organ toxicity – Single Exposure

    N/A

    Specific target Organ toxicity – Repeated Exposure

    N/A

    Aspiration Hazard

    N/A

    Additional Information

    RTECS

    N/A

    General Information

    To the best of our knowledge, the chemical, physical and toxicological properties have not been thoroughly investigated.

  • Section 12 – ECOLOGICAL INFORMATION

    Toxicity

    N/A

    Persistence & degradability

    N/A

    Bio accumulative Potential

    N/A

    Mobility in Soil

    N/A

    Result of PBT & vPvB assessment

    PBT/vPvB assessment not available as chemical safety assessment not required/not conducted.

    Other adverse effects

    N/A

  • Section 13 – DISPOSAL CONSIDERATION

    Product Disposal

    Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber.

    Contaminated Packaging

    Dispose of as unused product.

  • Section 14 – TRANSPORT INFORMATION

    UN No

    ADR/RID

    2907

    IMDG

    2907

    IATA

    2907

    UN Proper Shipping Name

    ADR/RID

    Isosorbide dinitrate mixture

    IMDG

    Isosorbide dinitrate mixture

    IATA

    Isosorbide dinitrate mixture

    Transport Hazard Class(es)

    ADR/RID

    4.1

    IMDG

    4.1

    IATA

    4.1

    Packaging Groupe

    ADR/RID

    No

    IMDG Marine Pollutant

    No

    IATA

    No

    Environmental Hazardse

    ADR/RID

    No

    IMDG Marine Pollutant

    No

    IATA

    No

    Special Precautions for User

    N/A

  • Section 15 – REGULATORY INFORMATION

    General Information

    This Safety Data Sheet was prepared in accordance with Regulation (EC) No. 1907/2006.

  • Section 16 – OTHER INFORMATION

    Global Pharma provides information contained herein in good faith but makes no representation as to its comprehensives or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product.

    Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.

    GLOBAL PHARMA MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OR MERCHANTABILITY, FITNESS FOR A PARTICULER PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT WHICH THE INFORMATION REEFERS. GLOBAL PHARMA WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF RELIANCE UPON THIS INFORMATION.

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