Risperidone is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Risperidone is used to treat schizophrenia and symptoms of bipolar disorder (manic depression). It is also used in autistic children to treat symptoms of irritability.

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

Certificate of Analysis

• Description

  A White or almost White powder.

  Result

  Complies.

• Identification by IR

  The absorption maxima, minima in the spectrum obtained with the sample shall be concordant in position & relative intensity to those in the spectrum obtained to that of CRS.

  Result

  Complies.

• Solubility

  Practically insoluble in water, freely soluble in Methylene chloride, sparingly soluble in ethanol (96 %). It dissolves in dilute acid solution.

  Result

  Complies.

• Loss on drying

  NMT 0.50 %w/w.

  Result

  0.22 % w/w.

• Appearance of Solution

  The solution should be clear & colour less.

  Result

  Complies.

• Sulphated Ash

  NMT 0.10 % w/w/.

  Result

  0.06 % w/w.

• Assay (on dry basis)

  NLT 99.0 % & NMT 101.0 %w/w.

  Result

  99.6 % w/w.

• Related Substances by HPLC
  Result

• Impurity A

  Not more than 0.2 %

  Result

  Not Detected.

• Impurity B

  Not more than 0.2 %

  Result

  Not Detected.

• Impurity C

  Not more than 0.2 %

  Result

  Not Detected.

• Impurity D

  Not more than 0.2 %

  Result

  Not Detected.

• Impurity E

  Not more than 0.2 %

  Result

  Not Detected.

• Any other Impurity

  Not more than 0.1 %

  Result

  0.06 %

• Total Impurities

  Not more than 0.3 %

  Result

  0.16 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Risperidone

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Risperidone

  Synonym

  -[2-[4-(6-fluoro-benzo[d]isoxazol-3-yl)-1-piperidyl]ethyl]- 3-methyl-2,6-diazobiyclo[4.4.0]deca-1,3-dien-5-one.

  Molecular Weight

  410.49

  CAS Number

  106266-06-2

• 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.

  Potential Acute Health

  Hazardous in case of ingestion. Slightly hazardous in case Effects of skin contact, of eye contact, of inhalation.

  Potential Chronic Health Effects

  Hazardous in case of ingestion. Slightly hazardous in case of Effects skin contact, of eye contact, of inhalation.

  Carcinogenic Effects

  N/A

  Mutagenic Effects

  N/A

  Teratogenic Effects

  N/A

  Development Toxicity

  N/A

• 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 Product

  May be combustible at high temperature.

  Fire Fighting Media

  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 Large Fire

  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

  Solid

  Color

  White to almost white powder

  Odor

  N/A

  Taste

  N/A

  pH

  N/A

  Boiling Point

  Decomposes

  Melting Point

  165ºc – 170 ºc

  Critical Temperature

  N/A

  Specific Gravity

  N/A

  Vapor Pressure

  N/A

  Vapor Density

  N/A

  Volatility

  N/A

  Odor Threshold

  N/A

  Water/Oil Dist. Coeff.

  N/A

  Ionicity (in Water)

  N/A

  Dispersion Properties

  N/A

  Solubility

  Particularly insoluble in water, freely soluble in methylene chloride, sparingly soluble in alcohol. It dissolves in dilute acid solutions.

• Section 10 – STABILITY AND REACTIVITY

  Stability

  Stable at normal temperatures & pressures.

  Conditions to Avoid

  Avoid ignition sources & incompatible materials

  Material to Avoid

  Oxidizing & reducing agents

  Hazardous Decomposition Products

  Carbon dioxide, carbon monoxide, HF & nitrogen oxides

• Section 11 – TOXICOLOGICAL INFORMATION

  Acute Effects

  Harmful if swallowed. To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.

• 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 the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state and local environmental regulations.

• 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.