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 %

Note: We are leading channel partner of much API manufacturer, supplier & exporters and Pharmaceutical raw material in Colombo, Chili, Ecuador and Globally.

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.