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

Piroxicam is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis.

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

Certificate of Analysis

• Description

  Off –white to light tan or light yellow powder; Odourless.

  Result

  Off –white to light tan or light yellow powder; Odourless.

• Solubility

  Practically insoluble in water, in dilute acid, & in most organic solvent; slightly soluble in alcohol & in aqueous alkaline solutions./ Practically in soluble in water, soluble in methylene chloride, slightly soluble in anhydrous ethanol./ Slightly soluble in ethanol & in aqueous alkaline solution; very slightly soluble in water, in dilute acids & in most organic solvents.

  Result

  Complies.

• Identification

  To Comply IR test. / To Comply light absorption test. / To Comply TLC test.

  Result

  All Complies

• Related substances
  Result

• Impurity A

  Not more than 0.20 %

  Result

  Not Detected

• Impurity B

  Not more than 0.20 %

  Result

  0.0429 %

• Impurity D

  Not more than 0.20 %

  Result

  Not Detected

• Impurity G

  Not more than 0.20 %

  Result

  0.0641 %

• Impurity J

  Not more than 0.10 %

  Result

  Not detected.

• Unspecified Impurity

  Not more than 0.20 %

  Result

  0.0563%

• Total Impurities

  Not more than 0.40 %

  Result

  0.2311%

• Heavy metals

  Not more than 50 ppm /Not more than 20 ppm.

  Result

  Complies

• Loss on Drying

  Not more than 0.5 % w/w.

  Result

  0.12 % w/w.

• Water

  Not more than 0.5 % w/w.

  Result

  0.14 % w/w.

• Sulphated Ash

  Not more than 0.3 % / Not more than 0.1 %

  Result

  0.080 % w/w.

• Assay (By HPLC)

  NMT 97.0 % & NMT 103.0 % of piroxicam, on dried basis.

  Result

  99.75 % w/w.

• Assay (By Titration)

  NLT 98.5 % & NMT 101.0 % of piroxicam, on dried basis.

  Result

  99.66 % w/w.

• Particle Size (Dry Method )

  100 % less than 20 micron

  Result

  Complies.

Note: 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

  Piroxicam

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Piroxicam

  Molecular Formula

  C15H13N3

  Molecular Weight

  331.35

  CAS Number

  36322-90-4

• 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

  Eye Contact

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

  Skin Contact

  Wash skin with water.

  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

  Flammable Properties

  Flash Point (Deg. C/Deg. F)

  N/A

  Flammable Limits (Lower) (%v/v)

  N/A

  Flammable Limits (Upper) (%v/v)

  N/A

  Auto Ignition Temperature (Deg. C/Deg. F)

  No data Combustible. If involved in a fire, it may emit flammable vapours.

  Extinguishing Media

  Water spray, foam, dry chemical or CO2.

  Fire-Fighting Instructions

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

• Section 6 – ACCIDENT RELEASE MEASURES

  Small Spillages

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

  Large Spillages

  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

  Respiratory

  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 shield in addition if splashing is possible.

  Other Protective Equipment

  Eye wash station & safety shower in work area.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Form

  Crystalline powder.

  Colour

  White to slightly yellow.

  Odour

  Odourless

  Melting Point

  198°-201°C

  Vapor Pressure

  N/A

  Solubility

  Insoluble

  Vapour Density

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Stability

  Stable under normal condition.

  Incompatible Materials

  No

  Hazardous Decomposition Products

  No

• Section 11 – TOXICOLOGICAL INFORMATION

  Inhalation

  It may cause to mucous membrane and loss of consciousness.

  Skin Contact

  Repeated or prolonged skin contact may cause irritation in sensitive individuals.

  Eye Contact

  Liquid splashes may cause eye irritation.

  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 methylene dichloride.

  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

  General 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.