Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Meloxicam is used to treat pain or inflammation caused by rheumatoid arthritis and osteoarthritis in adults.

Meloxicam is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.

Certificate of Analysis

• Description

  A Pale yellow powder.

  Result

  A Pale yellow powder.

• Solubility

  Practically soluble in water, Soluble in x ; very slightly soluble in ethanol (96%).Soluble in dimethylformamide; slightly soluble in acetone, very slightly in Methanol & alcohol; Practically insoluble in water.

  Result

  Complies

• Identification

  The infrared absorption spectrum is concordant with the reference spectrum / Examined between 240 nm to 450 nm, the solution shows maximum absorption at 354 nm & absorbance at 354 nm is about 0.8.

  Result

  Both Complies

• Related Substances
  Result

• Impurity A at 350 nm

  NMT 0.1 %

  Result

  Not Detected

• Impurity B at 260 nm

  NMT 0.1 %

  Result

  0.0164 %

• Impurity C at 350 nm

  NMT 0.05 %

  Result

  Not Detected

• Impurity D at 350 nm

  NMT 0.05 %

  Result

  Not Detected

• Single Unknown Impurity

  NMT 0.1 %

  Result

  0.0237 %

• Total Impurities

  NMT 0.3 %

  Result

  0.040.2 %

• Heavy Metals

  Not more than 10 ppm / Not more than 20 ppm.

  Result

  Complies

• Loss on drying

  Not more than 0.5 % w/w.

  Result

  0.24 % w/w.

• Sulphated Ash

  Not more than 0.1 % w/w.

  Result

  0.070 % w/w.

• Residue on Ignition

  Not more than 1.0 % w/w.

  Result

  0.070 % w/w.

• Assay (by HPLC)

  NLT 99.00 % & NMT 100.50 % of C14H13N3O4S2, On dried basis.

  Result

  99.63 % w/w.

• Assay

  NLT 99.00 % & NMT 101.00 % of C14H13N3O4S2, On dried basis.

  Result

  99.78 % 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

  Meloxicam

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Meloxicam

  Molecular Formula

  C14H13N3O4S2

  Molecular Weight

  351.40

  CAS Number

  71125-38-7

• Section 3 – HAZARDOUS IDENTIFICATION

  General Information

  To the best of our knowledge, the Chemical / Toxicological / Physical properties of this compound have not been fully investigated. May be harmful by ingestion. Exercise appropriate precaution to prevent opportunity for inhalation and to prevent direct contact with skin and eyes.

• Section 4 – FIRST AID

  Skin

  Wash skin with water.

  Eye Contact

  Irrigate with eyewash solution or clean water, holding the eyelids apart, for at least 15 minutes. Obtain medical attention.

  Inhalation

  Remove patient from exposure, keep warm and at rest. Obtain medical attention if ill effects occur.

  Ingestion

  Wash out mouth with water. Obtain medical attention.

• Section 5 – FIRE FIGHTING MEASURES

  Flammability of Product

  N/A

  Auto-ignition Temperature

  N/A

  Flash Point

  N/A

  Extinguishing Media

  Water spray, foam, dry chemical or CO2.

  Fire-Fighting Instructions

  A self-contained breathing apparatus and suitable protective clothing should be worn in fire conditions.

• Section 6 – ACCIDENT RELEASE MEASURES

  Small Spills

  Clear up spillages. Drench spillages with water and wash to drain.

  Large Spills

  Do not allow to enter drains, sewers, or watercourses. Absorb spillages onto sand, earth, or any suitable absorbent material. Transfer to a container for disposal. Wash the spillage area with water, and flush to a sewer services by a wastewater treatment facility.

• Section 7 – HANDLING AND STORAGE

  Handling

  This product should handle only by qualified experienced persons with adequate ventilation. Use appropriate safety devices while handling. Wash thoroughly after handling this material. Avoid contact with eyes.

  Storage

  Keep container tightly closed. Protect from light.

  Storage Temperature

  Room Temperature

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Personal Protective Equipment

  Respirators

  Use NIOSH approved respirator for dusts, mists, and fumes with a TLV greater than 0.05 mg/m3 in combination with an organic vapor cartridge.

  Protective Clothing

  Impervious gloves and apron.

  Eye Protection

  Chemical tight goggles; full face shields in addition if splashing is possible.

  Other Protective Equipment

  Eyewash station and safety shower in work area.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Form

  Crystalline powder

  Colour

  Pale yellow

  Melting Point (Deg C/Deg F)

  254° C

  Boiling Point (Deg C/Deg F)

  N/A

  Vapor Pressure (mm Hg)

  N/A

  Solubility (Water)

  Insoluble (Soluble in dimethylformamide)

  Vapor Density (Air = 1)

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable under normal conditions.

  Incompatible Materials

  N/A

  Hazardous Decomposition Product(s)

  N/A

• Section 11 – TOXICOLOGICAL INFORMATION

  Inhalation

  It may cause to mucous membrane and loss of consciousness.

  Skin Contact

  Primary irritant effect: on the skin: No irritant effect.

  Eye Contact

  No sensitizing effects known.

  Ingestion

  The swallowing of small splashes is unlikely to cause any adverse effects.

• Section 12 – ECOLOGICAL INFORMATION

  Environmental Fate and Distribution

  The product is soluble in dimethylformamide.

  Toxicity

  Not Harmful to aquatic organisms, it may cause long-term effects in the environment.

  Effect on Effluent Treatment

  Low toxicity to sewage microorganisms.

• Section 13 – DISPOSAL CONSIDERATION

  General Information

  Disposal should be in accordance with local, state, or national legislation.

  Disposal Method

  Discarded product is not a hazardous waste.

  Container Disposal

  Empty container contains product residue. Observe all hazard precautions.

• Section 14 – TRANSPORT INFORMATION

  Not Classified as Dangerous for Transport.

• Section 15 – REGULATORY INFORMATION

  TSCA (Toxic Substances Control Act) Regulations, 40 CFR 710

  Not listed

  CERCLA and SARA Regulations (40 CFR 355, 370, and 372)

  This product does not contain any chemicals subject to the reporting requirements of SARA Section 313

• 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.