Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain, fever, and inflammation

Ketorolac nasal (for the nose) is used short-term (5 days or less) to treat moderate to severe pain.

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

Certificate of Analysis

• Description

  White to off white Crystalline Powder. Melts between165° C and 170°C with decomposition.

  Result

  Complies

• Solubility

  Freely soluble in water & in methanol. Slightly Soluble in Ethanol& in THF. Insoluble in Methylene Chloride Acetone.

  Result

  Complies

• Infrared by IR

  IR of sample spectrum should match with that of working standard spectrum.

  Result

  Complies

• Identification by UV Absorbance

  As per IP

  Result

  Complies

• Identification by Tromethamine Test

  Should Pass Test

  Result

  79° C – 80° C

• pH ( 1 in 100 )

  Between 5.70 to 6.70.

  Result

  5.964

• Loss on Drying

  NMT 0.5 %

  Result

  0.21 %

• Residue on ignition

  NMT 0.1 %

  Result

  0.04 %

• Heavy Metals

  NMT 0.002 %

  Result

  Less than 0.002 %

• Chromatographic Purity

  As per IP

  Result

  Complies

• Assay

  98.5 % to 101.5 %

  Result

  99.74 %

• Microbial Analysis

  As per IP.

  Result

  Complies

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

  Ketorolac Tromethamine

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Ketorolac Tromethamine

  Synonym

  5-Benzoyl -2,2-dihydro 1-H Pyrrolizine 1- Carboxylic acid with 2-amini-2-(hydroxymethyl)-1, 3-propanediol

  Molecular Formula

  C15H12NO3. C4H12NO3

  Molecular Weight

  376.40

  CAS Number

  74103-07-4

• Section 3 – HAZARDOUS IDENTIFICATION

  Emergency Overview

  Toxic

  Routes of Entry

  Inhalation. Eyes. Skin. Ingestion.

  Health Hazards

  Cause eye, skin or repository system irritation. Material is irritating to the mucous membranes and upper respiratory tract. May be harmful by inhalation or skin absorption. Toxic if swallowed. The Toxicological properties of this product have not been fully Evaluated

• Section 4 – FIRST AID

  Skin Contact

  In case of skin contact, immediately wash skin with soap & plenty of water for 25 minutes. Remove contaminated clothing. Get medical attention if symptoms occur. Wash clothing before reuse.

  Eye Contact

  In case of contact with eyes, hold eyelids apart & flush eyes with plenty of water for at least 15 minutes. Have eyes examined and tested by medical personnel.

  Inhalation

  If inhaled, remove to fresh air. If not breathing, give artificial respiration or given oxygen by trained personnel. Get immediate medical attention.

  Ingestion

  If swallowed, wash out mouth with water provided person is conscious. Never give anything by mouth to unconscious person. Get medical attention. DO NOT induce vomiting unless directed to do so by medical personnel.

• Section 5 – FIRE FIGHTING MEASURES

  Flash Point

  N/A

  Explosion Limit

  N/A

  Special fire-fighting Procedures

  As in case of fire, wear self-contained breathing apparatus pressure Demand, and full protective Gear to Prevent contact with skin & eyes.

  Unusual Fire & Explosion Hazard

  N/A

  Hazardous Combustion Products

  N/A

  Suitable Existing Media

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

  Unsuitable Extinguishing Media

  A solid water stream may be inefficient.

• Section 6 – ACCIDENT RELEASE MEASURES

  Spills / Leaks

  Avoid release into environment. Avoid rising & breathing dust & provide adequate Ventilation. As conditions warrant, wear a NIOSH approved self-contained breathing apparatus or respirator, & Appropriate personal protection. Transfer to a proper chemical waste container for disposal.

• Section 7 – HANDLING AND STORAGE

  Hazard label Information

  Avoid contact with skin & eyes. Do not reuse this container, Use with Adequate ventilation. Wash thoroughly after handling.

  Handling

  Avoid breathing. Avoid prolonged or repeated exposure.

  Storage

  Keep tightly closed. Store at current temperature.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Hazard label Information

  Compatible chemical- resistance gloves. Eye wash station in work area lab coat, safety glasses, safety shower in work area went hood.

  Respiratory Equipment

  NIOSH approved respirator, as conditions warrant.

  Protective Gloves

  Compatible chemical resistance gloves.

  Eye Protection

  Safety Glasses

  Other Protective Clothing

  Lab coat

  Ventilation

  Use process enclosures, local exist ventilation, or other Engineering controls to control air borne levels below recommended exposure limits.

  Maintenance Practices

  Do not take internally. Facilities storing or utilizing this material should be equipped with an eye wash facility and a safety shower. Wash thoroughly after handling.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical State

  Solid

  Melting Point

  166 ° C

  Boiling Point

  N/A

  Auto-ignition Temp

  N/A

  Flash Point

  N/A

  Specific Gravity

  N/A

  Bulk Density

  0.52 g/CC

  Vapor Pressure

  N/A

  Evaporation Rate

  N/A

  Vapour Density

  N/A

  Solubility in Water

  Free Soluble

  % Volatile

  N/A

  Heat Value

  N/A

  Particle Size

  N/A

  Corrosion Rate

  N/A

  pH

  N/A

  Appearance

  White powder solid

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable

  Condition of Instability

  N/A

  Incompatibility Materials

  Strong oxidizing agents.

  Hazardous decomposition products

  Carbon dioxide, Carbon monoxide, Nitrogen Oxides.

  Hazardous Polymerization

  Will not occur.

• Section 11 – TOXICOLOGICAL INFORMATION

  Toxicological Information

  The Toxicological effects of this product have not been thoroughly studied.

  Oral LD50 Rat

  189 mg/kg

  Carcinogenicity / Other Info

  N/A

  Carcinogenicity

  NTP

  NO

  IARC Monographs

  NO

  OSHO Regulated

  NO

• Section 12 – ECOLOGICAL INFORMATION

  General Information

  Avoid release into the environment. Runoff from fire control or dilution water may cause pollution.

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  Dispose in accordance with local, state & central regulations.

• Section 14 – TRANSPORT INFORMATION

  DOT Hazard Class

  N/A

  DOT Hazard Label

  N/A

  UN/NA Number

  N/A

  Packing Group

  N/A

• Section 15 – REGULATORY INFORMATION

  No data available.

• 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.