Quetiapine is an antipsychotic medicine. It works by changing the actions of chemicals in the brain. Quetiapine is used to treat schizophrenia in adults and children who are at least 13 years old. Quetiapine is used to treat bipolar disorder (manic depression) in adults and children who are at least 10 years old. Quetiapine is also used together with antidepressant medications to treat major depressive disorder in adults. Extended-release quetiapine (Seroquel XR) is for use only in adults and should not be given to anyone younger than 18 years old. Quetiapine may also be used for purposes not listed in this medication guide.

Certificate of Analysis

• Description

  White or almost white powder.

  Result

  White powder.

• Identification by IR

  IR of sample spectrum should match with that of working standard spectrum.

  Result

  Complies

• Identification by HPLC

  The retention time of the major peak of the sample solution corresponds to that of the standard solution.

  Result

  Complies

• Assay by HPLC (On dried basis)

  NLT 98.0 % & NMT 102.0 %

  Result

  99.91 %

• Residue on ignition

  NMT 0.1 %

  Result

  0.04 %

• Organic Impurities by HPLC

  As per USP

  Result

  Complies

• Loss on drying

  NMT 0.5 %

  Result

  0.17 %

• Fumaric acid

  Between 12.5 & 13.8 %

  Result

  13.6 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Quetiapine Fumarate

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Quetiapine Fumarate

  Synonym

  Quetiapine hemi Fumarate

  Molecular Formula

  C21H25N3O2S)2.C4H4O4

  Molecular Weight

  883.09

  CAS Number

  111974-72-2

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential Health Effects

  Eyes

  May cause mechanical irritation.

  Skin

  No adverse effect expected.

  Ingestion

  N/A

  Inhalation

  N/A

  Chronic Toxicity

  N/A

• Section 4 – FIRST AID

  Skin Contact

  Remove contaminated clothing, Jewellery & shoes immediately. Wash with soap or mild detergent & plenty of water until the chemical is completely removed. Get medical attention if required.

  Eye Contact

  Immediately flush eyes plenty of water or normal saline, occasionally lifting lower & upper lids, till eyes become normal. Get medical attention if required.

  Inhalation

  Remove from exposure immediately. Use a bag value mask or similar device to perform artificial respiration if needed. Get medical attention.

  Ingestion

  If vomiting occurs, keep hard lower than hips to help prevent aspiration. Get medical attention if required.

• Section 5 – FIRE FIGHTING MEASURES

  Fire

  Non hazard. Dust & air mixtures may ignite.

  Fire Extinguishing Media

  Small Fire

  Water spray, Dry chemical powder, Foam or carbon dioxide.

  Large Fire

  Form or flooded water spray.

  Fire-Fighting

  Move container from fire area, if It can be done without risk. Do not scatter spilled material with high pressure water steams. Keep aside for later disposal. Avoid inhalation of material or combustion by-products. Stay up wind & keep out of low areas.

• Section 6 – ACCIDENT RELEASE MEASURES

  General Information

  Remove all source of ignition. Wear appropriate personal protective equipment as specified in section 8. Isolate hazard area. Keep unnecessary & unprotected personnel from entering. All clean-up operations should be witnessed by more than one individual. Carefully sweep up spilled material into an appropriate container & keep for reclamation or disposal. Use non-sparking tools & equipment. DO not flush to sewer! The amount of material collected should be assessed & documented.

• Section 7 – HANDLING AND STORAGE

  General Information

  Keep in a tightly closed container, stored in ambient condition. Protect from physical damage & direct sunlight. Storage area location must comply with current regulations. Keep separated from in- compatible substances. Wear personnel protective equipment while handling. Do not breathe dust. Do not get in eyes or skin. Wash thoroughly after handling.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Exposure Limits

  No occupational exposure limits established.

  Ventilation

  Provide local exhaust ventilation system. Ventilation equipment should be explosion resistant.

  Eye Protection

  Wear splash resistant Safety Goggles. Maintain eye wash fountain & quick-drench shower in immediate work area.

  Clothing

  Gloves & lab coat, apron or overalls.

  Gloves

  Wear appropriate chemical resistant hand gloves.

  Respirator

  Any air-purifying respirator with high efficiency-particulate filter. Any powdered, air- purifying respirator with high efficiency-particulate filter. Amy self-contained breathing apparatus with a full face piece. For unknown concentrations or immediately dangerous to life or health – any supplied air-respirator with full piece of positive pressure mode in combination with a separate escape facility.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Appearance

  White to off white powder

  Odor

  Odorless

  Water Solubility

  Insoluble in Water

  Volatility

  N/A

  Boiling Point

  N/A

  Melting Point

  265°C – 275°C

  Decomposition Point

  About 280°C

  Bulk Density

  0.55 g/cc

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable under normal Temperature & Pressure conditions.

  Conditions to avoid

  Avoid Heat, Flames, sparks & other sources of ignition. Avoid contact with incompatible materials.

• Section 11 – TOXICOLOGICAL INFORMATION

  Data not available.

• Section 12 – ECOLOGICAL INFORMATION

  Data Not Available.

• Section 13 – DISPOSAL CONSIDERATION

  General Information

  Dispose in accordance with applicable regulations. Burn in a chemical incinerator equipped with an afterburner & scrubber.

• Section 14 – TRANSPORT INFORMATION

  UN Number

  N/A

  ADR/RID

  No classification assigned.

  IATA/IACO

  No classification assigned.

  IMDG

  N/A

• Section 15 – REGULATORY INFORMATION

  US Regulations

  N/A

  European Regulations

  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.