Fexofenadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Fexofenadine is used to treat the symptoms of seasonal allergies (hay fever) in adults and children.

Fexofenadine is also used to treat skin itching and hives caused by a condition called chronic idiopathic urticaria in adults and children.

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

Certificate of Analysis

• Description

  White to off white powder.

  Result

  White powder

• Solubility

  Soluble in methanol.

  Result

  Complies

• Identification By IR

  The infrared absorption spectrum of the preparation of the test sample shall exhibit maxima only at the same wavelength as that of similar preparation of Fexofenadine HCL working standard.

  Result

  Complies

• Identification By HPLC

  The retention time of principal peak in the sample chromatogram should be concordant with that of the principal peak in the standard chromatogram obtained from assay by HPLC test.

  Result

  Complies

• Test for chlorides

  The white precipitate should be formed in the present of chloride ions.

  Result

  Complies

• Water by K.F.

  Not more than 0.50 % w/w.

  Result

  0.24 % w/w

• Residue on ignition

  Not more than 0.10 % w/w.

  Result

  0.06 % w/w

• Heavy metals

  Not more than 20 ppm

  Result

  Less than 20 ppm

• Related substances by HPLC

  Result

• Related compound – A

  Not more than 0.2 %

  Result

  0.03 %

• Decarboxylated degradant

  Not more than 0.15 %

  Result

  ND

• Single major unknown impurity

  Not more than 0.1%

  Result

  0.06%

• Total impurities

  Not more than 0.5%

  Result

  0.27%

• Content of chlorides (on anhydrous basis)

  Not less than 6.45% & Not more than 6.75 %

  Result

  6.54 % w/w

• Assay by HPLC (an anhydrous basis)

  Not less than 98.0 % & Not more than 102.0 % w/w.

  Result

  99.26 % w/w

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

  Fexofenadine HCL

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Fexofenadine Hydrochloride

  Molecular Formula

  C32H39NO4.HCL

  Molecular Weight

  538.12

  CAS Number

  138452-21-8

• Section 3 – HAZARDOUS IDENTIFICATION

  Caution

  Avoid contact & Inhalation.

  HMIS Rating

  Health

  1

  Flammability

  0

  Reactivity

  0

  NFPA Rating

  Health

  1

  Flammability

  0

  Reactivity

  0

• Section 4 – FIRST AID

  Skin Contact

  In case of contact, immediately wash skin with soap & copious amounts of water.

  Eye Contact

  In case of contact with eyes, flush with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating the eyelids with gingers. Call a physician.

  Inhalation

  If inhaled, remove to fresh air. If breathing becomes difficult, call a physician.

  Ingestion

  If swallowed, wash out with water provided person is conscious. Call a physician.

• Section 5 – FIRE FIGHTING MEASURES

  Flash Point

  N/A

  Flammability

  N/A

  Auto-ignition Temperature

  N/A

  Extinguishing Media

  Water spray, Carbon dioxide, dry chemical powder, foam or any ABC class.

  Fire-fighting Procedures

  Use self-contained breathing apparatus and full protective equipment/ clothing to prevent contact with skin & eyes.

  Unusual Fire & Explosion Hazard

  Emits toxic fumes under fire conditions.

• Section 6 – ACCIDENT RELEASE MEASURES

  Personal Precaution

  Exercise appropriate precautions to minimize direct contact with skin or eyes and prevent inhalation of dust.

  Methods for Cleaning Up

  Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete.

• Section 7 – HANDLING AND STORAGE

  Handling

  The user should use protective gloves and avoid breathing the dust generated out of this material. Do not get in eyes, on skin, or in clothing. Do not ingest or inhale.

  Storage

  Store in well closed container at ambient temperature, protect from light.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Safety shower and eye bath. Mechanical exhaust required.

  Personal Protective Equipment

  Respiratory Protection

  Wear dust mast.

  Hand Protection

  Protective gloves.

  Eye Protection

  Chemical safety googles

  General Hygiene Measures

  Wash thoroughly after handling.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical State

  White or almost white crystalline powder.

  Boiling Point

  N/A

  pH

  N/A

  Solubility in Water

  Soluble

  Decomposition Temperature

  N/A

  Explosion Limits

  N/A

  Vapor Pressure

  N/A

  Vapour Density

  N/A

  Specific Gravity

  N/A

  Auto-ignition Temp

  N/A

  Freezing Point

  N/A

  Refractive Index

  N/A

  Decomposition Temp

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable under normal temperatures and pressure.

  Incompatibilities

  Strong oxidizing agents

  Hazardous decomposition products

  Will not occur.

• Section 11 – TOXICOLOGICAL INFORMATION

  Skin Contact

  May cause skin irritation.

  Skin Absorption

  May be harmful if absorbed through the skin.

  Eye Contact

  May cause eye irritation.

  Inhalation

  May be harmful if inhaled. Material may be irritation to mucous membranes and upper respiratory tract.

  Ingestion

  May harmful if swallowed.

• Section 12 – ECOLOGICAL INFORMATION

  Environmental Stability

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  Material Disposal

  Contact a licensed professional waste disposal service to dispose or this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state & local environmental regulations.

• Section 14 – TRANSPORT INFORMATION

  General Information

  The material is not Hazardous as defined by IATA/IMDG/RID/ADR.

• 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.