Ondansetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Ondansetron is used to prevent nausea and vomiting that may be caused by surgery, cancer chemotherapy, or radiation treatment.

Ondansetron may be used for purposes not listed in this medication guide.

Certificate of Analysis

• Description

  A White to off-white Powder.

  Result

  An off White coloured powder.

• Solution

  Freely soluble in acid solution & sparingly soluble in 0.1N HCI.

  Result

  Freely soluble in acid solution & sparingly soluble in 0.1N HCI.

• Identification by IR

  The IR Spectrum of the sample should be in concordant with that of “ Ondansetron working standard.”

  Result

  Complies

• Identification by HPLC

  The retention time of the sample should be in concordant with that of the Ondansetron working standard in “Assay by HPLC“ test.

  Result

  Complies

• Water by KF

  Not more than 3.0 % w/w.

  Result

  1.7 % w/w.

• Residue on ignition

  Not more than 0.1 % w/w.

  Result

  0.02 % w/w.

• Chloride test

  Chloride test

  Result

  Below 0.02 %

• Limits of Ondansetron related compound D

  Not more than 0.10 %

  Result

  Below LOQ

• Related substances by HPLC
  Result

• Individual Impurity

  Not more than 0.1 %

  Result

  0.04 %

• Total impurities

  Not more than 0.5 %

  Result

  0.04%

• Assay by HPLC (On anhydrous basis)

  98.0 % – 102.0 % w/w.

  Result

  99.8 % w/w.

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

  Ondansetron Base

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Ondansetron Base

  Synonym

  0-Methyl-3-2) 2-methyl-imidazol-1-ylmethyl) -1,2,3,9-tetrahydro-carbazol-4-one

  Molecular Formula

  C18H19N3O

  Molecular Weight

  293.36

  CAS Number

  99614-02-5

• Section 3 – HAZARDOUS IDENTIFICATION

  Emergency Overview

  Irritating to eyes, respiratory system and skin.

  Potential Health Effects

  Eyes

  Cause eye irritation.

  Skin

  Cause skin irritation. May be harmful, if absorbed through skin.

  Ingestion

  May cause irritation of the digestive tract. May be harmful if swallowed.

  Inhalation

  May cause respiratory tract irritation. May be harmful if inhaled.

  Chronic

  N/A

• Section 4 – FIRST AID

  Skin Contact

  Wipe off excess material from skin then immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Get medical attention immediately, Wash clothing and shoes thoroughly before reuse.

  Eye Contact

  Immediately flush eyes with plenty of water for at least 15 minutes lifting lower and upper eyelids occasionally. Get medical attention immediately.

  Inhalation

  Remove to fresh air. Get medical attention immediately.

  Ingestion

  If swallowed, INDUCE VOMITTING. Give large quantities of water. Never give anything by mouth to an unconscious person. Get medical attention immediately.

• Section 5 – FIRE FIGHTING MEASURES

  General Information

  As in any fire, wear a self-contained breathing apparatus in pressure-demand, and full protective wear.

  Extinguishing Media

  Use water spray, dry chemical, carbon dioxide or chemical form.

• Section 6 – ACCIDENT RELEASE MEASURES

  General Information

  Use proper personal protective equipment as indicated in Sction-8.

  Spills/Leaks

  Ventilate area of spill. Isolate hazard area. Keep away unnecessary and unprotected personnel from entering. Flush with water. Use wet mop or vacuum to pick up spilled product. Dispose the collected powder and washings as per local laws.

• Section 7 – HANDLING AND STORAGE

  Handling

  Avoiding breathing powder, vapor, mist or gas. Avoid contact with skin and eyes.

  Storage

  Preserve in air tight containers protected from light.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Facilities storing or utilizing this material should be equipped with an eye wash facility and a safety shower. Use adequate ventilation to keep airborne concentrations low.

  Personal Protective Equipment

  Skin

  Wear appropriate protective glove to prevent skin exposure.

  Eye Protection

  Wear appropriate protective eyeglasses or chemical safety googles as described by OSHA`s eye & face protective regulations.

  Clothing

  Wear appropriate protective clothing to prevent skin exposure.

  Respirators

  Follow the OSHA respirators regulations.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical State

  Powder

  Color

  An off white to white crystalline Powder

  Odor

  N/A

  Viscosity

  N/A

  Auto-ignition Temperature

  N/A

  Flash Point

  N/A

  Explosion Limit, Lower

  N/A

  Decomposition Temperature

  N/A

  Solubility in Water

  N/A

  Freezing / Melting Point

  N/A

  Specific Gravity / Density

  N/A

  Vapour Density

  N/A

  Vapour Pressure

  N/A

  Assay

  98 % (+)

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Suitable at Room temperature in closed containers under normal storage and humidity condition.

  Conditions to avoid

  Incompatible materials

  Incompatible with Others

  Strong oxidizing agents.

  Hazardous decomposition products

  Hydrogen bromide, Nitrogen oxide, Carbon monoxide.

  Hazardous Polymerization

  Has not been reported.

• Section 11 – TOXICOLOGICAL INFORMATION

  Oral Rat

  LD 50: 350 mg/kg

  General Information

  To the best of our knowledge the toxicological properties have not been thoroughly investigated. However, harmful if swallowed in large amount, causes irritation if it contacts with eyes.

• Section 12 – ECOLOGICAL INFORMATION

  Data Not Available.

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing, use or contamination of this product may change the waste management options. Dispose off container and unused contents in accordance with federal and local requirements.

• Section 14 – TRANSPORT INFORMATION

  General Information

  IATA Non-hazardous transport.

• Section 15 – REGULATORY INFORMATION

  European / International Regulations

  Hazard Symbols

  Non-hazardous

  Risk Phrases

  Irritating to eyes, respiratory system and skin.

  Safety Phrases

  In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

• 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.