Cetirizine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. It is used to treat cold or allergysymptoms such as sneezing, itching, watery eyes, or runny nose.

Cetirizine is also used to treat itching and swelling caused by hives.

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

 

Certificate of Analysis

• Description

  White or almost white powder.

  Result

  White powder.

• Solubility

  Freely soluble in water, practically insoluble in acetone & in Methylene chloride.

  Result

  Complies

• Identification by IR

  Should match with the standard.

  Result

  Complies

• Identification by Reaction of chlorides

  Should be complies.

  Result

  Complies

• Identification by UV observance

  The specific absorbance at maximum is 359 to 381.

  Result

  Complies

• Identification by TLC

  Should be complies.

  Result

  Complies

• Appearance of Solution

  Solution S should be clear & not more than intensely coloured than reference solution BY 7

  Result

  Complies

• pH

  Between 1.2 to 1.8

  Result

  1.61

• Loss on Drying

  NMT : 0.50 % w/w

  Result

  0.23 % w/w

• Heavy meals

  NMT : 10 ppm

  Result

  Less than 10 ppm

• Sulphated Ash

  NMT : 0.2 % w/w

  Result

  0.09 % w/w

• Assay (on dried basis)

  NLT : 99.0 % w/w & NMT : 100.5 % w/w

  Result

  99.53 % w/w

• Related substance by HPLC Any single impurity / Total impurity

  NMT : 0.10 % / NMT : 0.30 %

  Result

  0.08 % / 0.26 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Cetirizine HCL

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Cetirizine Dihydrochloride

  Synonym

  [2-]4-[(4-chlorophenyl) phenylmethy1] -1-piperaziny1] ethoxy] acetic acid dihydrochloride

  Molecular Formula

  C21H25Cl N2O3 2HCL

  Molecular Weight

  461.81

  CAS Number

  83881-52-1

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential acute health effects

  N/A

  Potential Chronic Health Effects

  Carcinogenic Effects

  N/A

  Mutagenic Effects

  N/A

  Teratogenic Effects

  N/A

  Development Toxicity

  N/A

• Section 4 – FIRST AID

  Skin Contact

  Get medical attention if irritation develops and persists.

  Serious Skin Contact

  N/A

  Eye Contact

  Get medical attention if irritation develops and persists.

  Inhalation

  Move to fresh air. Call a POISON CENTER or doctor/physician if you feel unwell.

  Serious Inhalation

  N/A

  Ingestion

  IF SWALLOWED; Call a POISON CENTER or doctor/physician if you feel unwell. Rinse mouth thoroughly.

  Serious Ingestion

  N/A

• Section 5 – FIRE FIGHTING MEASURES

  Flammability of the Product

  N/A

  Auto-ignition Temperature

  N/A

  Flash Point

  N/A

  Flammable Limits

  N/A

  Products of Combustion

  N/A

  Fire Hazards in presence of various substance

  N/A

  Risks of explosion of product in presence of mechanical impact

  N/A

  Risks of explosion of product in presence of static discharge

  N/A

  Special remarks on Fire Hazards

  N/A

  Fire Fighting Media & Instruction

  Small Fire

  Use DRY chemical powder.

  Large Fire

  Use water spray, fog or foam. Do not use water jet.

• Section 6 – ACCEDIENTAL RELEASE MEASURES

  Small Spill

  N/A

  Large Spill

  N/A

• Section 7 – HANDLING AND STORAGE

  Precautions

  As a general rule, when handling USO reference standards, avoid all contact and inhalation of dust, mists and/or vapors associated with the material. Clean equipment and work surfaces with suitable detergent or solvent after use. After removing gloves, wash hands and other exposed skin thoroughly.

  Storage

  Store in tight container as defined in the USP-NF. This material should be handled and stored per including any in compatibilities label instruction to ensure product integrity.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation is generally preferred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the effectiveness of engineering controls. Effectiveness of engineering controls intended for use with highly potent materials should be assessed by use of nontoxic surrogate materials.

  Personal Protection

  Eye Protection

  Safety glasses with side shields are recommended. Face shields or goggles may be required if splash potential exits or if corrosive materials are present. Approved eye protection is preferred. Maintain eyewash facilities in the work area.

  Hand Protection

  Chemically compatible gloves. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber should use nitrile or other synthetic non latex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy.

  Respiratory Protection

  Where respiratory are deemed necessary to reduce or control Occupational exposure, use NIOSH-approved respiratory protection and have an effectiveness respiratory program in place.

  Other

  For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significant quantities are handled, work clothing may be necessary to prevent take-home contamination.

  Exposure Limits

  N/A

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical State

  Solid & White crystalline powder.

  Color

  N/A

  Odor

  N/A

  Taste

  N/A

  ph

  1.2 – 1.8 (5% aqueous solution)

  Boiling Point

  N/A

  Melting Point

  437 F

  Critical Temperature

  N/A

  Specific Gravity

  N/A

  Vapour Pressure

  N/A

  Vapour Density

  N/A

  Volatility

  N/A

  Odor Threshold

  N/A

  Water / Oil Dist. Coeff

  N/A

  Iconicity (in water)

  N/A

  Dispersion Properties

  N/A

  Solubility

  Practically insoluble in acetone and in methylene chloride.

• Section 10 – STABILITY AND REACTIVITY

  Stability

  The Product is stable

  Instability Temperature

  N/A

  Condition of Instability

  N/A

  Incompatibility with various substance

  Not known

  Corrosivity

  N/A

  Special Remarks on Corrosivity

  n/a

  Special Remarks on Reactivity

  n/a

  Polymerization

  N/A

• Section 11 – TOXICOLOGICAL INFORMATION

  Route of Entry

  N/A

  Toxicity to Animals

  N/A

  Chronic Effects on Humans

  N/A

  Other Toxic Effects on Humans

  N/A

  Special Remarks on Toxicity to Animals

  N/A

  Special Remarks on chronic Effects on Humans

  N/A

  Special Remarks on other Toxicity effects to Humans

  N/A

• Section 12 – ECOLOGICAL INFORMATION

  Ecotoxicity

  No ecotoxicity data noted for the ingredients.

  BOD5 and COD

  N/A

  Products of Biodegradation

  N/A

  Toxicity of the products Biodegradation

  N/A

  Special Remarks on the Products of Biodegradation

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  Dispose of contents/container in accordance with local / regional / national / international regulations.

• Section 14 – TRANSPORT INFORMATION

  DOT Classification

  Not regulated as a hazardous material by DOT.

  Identification

  N/A

  Special provision for Transports

  N/A

• Section 15 – REGULATORY INFORMATION

  US classification and Label Text

  N/A

  US Regulatory Information

  N/A

  Canada Regulatory Information

  N/A

• 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.