Olanzapine is an antipsychotic medication that affects chemicals in the brain.

Olanzapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression) in adults and children who are at least 13 years old. Olanzapine is sometimes used together with other antipsychotic medications or antidepressants.

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

Certificate of Analysis

• Description

  A Yellow colour crystalline powder.

  Result

  Yellow colour crystalline powder.

• Identification By IR

  An IR spectrum of sample is concordant with IR spectrum of Olanzapine working standard.

  Result

  Complies.

• Related Substances by HPLC
  Result

• Any individual impurity

  NMT 0.50 %

  Result

  0.09 %

• Total impurity

  NMT 2.00 %

  Result

  0.14 %

• Heavy Metals

  NMT 10 ppm.

  Result

  Complies.

• Sulphated Ash

  NMT 0.10 % w/w.

  Result

  0.06 % w/w.

• Water Content

  NMT 1.00 % w/w.

  Result

  0.21 % w/w.

• Assay

  Between 98.0 % to 102.0 % on dried basis.

  Result

  99.6 % w/w.

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Olanzapine

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Olanzapine

  Synonym

  2-Methyl-4-(-4-methyl-1-piperazinyl)10H-thieno[2,3-b]

  Molecular Formula

  C17H20N4S

  Molecular Weight

  312.43

  CAS Number

  132539-06-1

• Section 3 – HAZARDOUS IDENTIFICATION

  Precautionary statements

  Hazardous in case of ingestion, Wear suitable Protective clothing and gloves. Harmful by inhalation, in contact with skin and if Swallowed. Not considered hazardous when handled under normal conditions with good house-keeping.

• Section 4 – FIRST AID

  Skin Contact

  Immediately wash skin with soap and copious amounts of water for at least 15 minutes. If irritation persists, seek medical attention.

  Eye Contact

  Immediately flush eyes with copious amounts of water for At least 15 minutes. Seek medical advice.

  Inhalation

  Remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. Seek medical attention.

  Ingestion

  If swallowed, wash out mouth with water, provided person is conscious. Seek medical advice. Remove and wash/dispose of contaminated clothing promptly.

• Section 5 – FIRE FIGHTING MEASURES

  Flammability of the Product

  May be combustible at high temperature.

  Fire Fighting Media and Instructions

  Small Fire

  Use Dry chemical powder, Carbon dioxide.

  Large Fire

  Use water spray, fog or foam.

  Special Fire-fighting

  Wear self-contained breathing apparatus and protective Procedures clothing to prevent contact with skin and eyes.

  Unusual fire and Explosion Hazard

  Emits toxic fumes under fire conditions.

• Section 6 – ACCIDENT RELEASE MEASURES

  Accessories

  Wear respirator, Chemical safety goggles, Rubber gloves.

  Spill

  Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements. Ensuring personal safety, mark out contaminated area with signs and prevent unauthorized access. Turn leaking containers up to prevent further Evacuate area. Wear self- contained breathing apparatus, rubber boots & heavy rubber gloves. Sweep-up/absorb in suitable material, place in a container and hold for disposal. Avoid raising dust. Ventilate area and wash spill site after pick-up complete.

• Section 7 – HANDLING AND STORAGE

  Storage

  Keep container dry. Store at room temperature and protect from light.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.

  Personal Protective Protection

  Safety shower and Eye bath.

  Personal Protection in Case of a Large Spill

  Splash goggles. Full suit. Dust respirator. Boots. Gloves. Wash thoroughly after handling. Do not breathe dust Avoid contact with eyes, skin and clothing.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical state and appearance

  Yellow crystalline powder

  Color

  A Brown to Yellow Crystalline Powder

  Odor

  Almost Odorless

  Melting Range

  195ºc

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable under normal temperatures and pressures.

  Conditions to avoid

  Unknown

  Materials to avoid

  Unknown

  Hazardous decomposition products

  Carbon dioxide, carbon monoxide, HF & nitrogen oxides

• Section 11 – TOXICOLOGICAL INFORMATION

  Acute Effects

  Harmful if swallowed.

• Section 12 – ECOLOGICAL INFORMATION

  Ecotoxicity

  N/A

  BOD5 and COD

  N/A

  Products of Biodegradation

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  General Information

  Dissolve or mix material with a suitable combustible solvent and incinerate in a chemical incinerator equipped with an afterburner and scrubber. Material should be disposed of in keeping with all local and national legislation. Packaging should be disposed of in keeping with all local and national legislation. Handle contaminated containers as product.

• Section 14 – TRANSPORT INFORMATION

  DOT Classification

  Not Restricted item according to the current IATA dangerous goods manual.

• Section 15 – REGULATORY INFORMATION

  European Information

  Caution

  In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

  Protective Equipment

  Gloves. Lab Coat. Dust respirator. Be sure to use an approved / certified respirator or equivalent. Safety glasses.

• 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.