Topiramate is a seizure medicine, also called an anticonvulsant. Topiramate is used to treat seizures in adults and children who are at least 2 years old. Trokendi XR is for use in adults and children who are at least 6 years old. Extended-release topiramate has a higher minimum age (at least 10 years old) when used as the child’s only seizure medicine. The Topamax and Qudexy brands of this medicine are also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. Topamax will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun. Topiramate may also be used for purposes not listed in this medication guide.

Certificate of Analysis

• Description

  A white to off-white powder.

  Result

  Off-white Powder

• 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 standard.

  Result

  Complies

• Melting Range

  Between 120° – 130° C

  Result

  126-128° C

• Solubility

  Freely soluble in acetone, chloroform, Dimethyl sulfoxide & ethanol.

  Result

  Complies

• Specific optical rotation at 20.0°C

  Between -28.0° to -36.0°

  Result

  -33.2°

• Related Substance by HPLC
  Impurity A

  NMT 0.15 %

  Result

  ND

• Impurity B

  NMT 0.15%

  Result

  ND

• Any other Impurity

  NMT 0.10%

  Result

  ND

• Total Impurities

  NMT 0.50%

  Result

  ND

• Heavy Metals

  NMT 20 ppm

  Result

  Complies

• Sulphated Ash

  NMT 1.00% w/w

  Result

  0.05%

• Water content

  NMT 1.00% w/w

  Result

  0.24%

• Assay by HPLC

  Between 98.0 & 102.0% w/w

  Result

  99.4%

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Topiramate

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Topiramate

  Synonym

  2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

  Molecular Formula

  C12H21NO8S

  Molecular Weight

  339.36 g/mole

  CAS Number

  97240-79-4

• 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 Effects

  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

  After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing.

  Eye Contact

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

  Inhalation

  Allow the victim to rest in a well ventilated area. Seek immediate medical attention.

  Ingestion

  Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.

• Section 5 – FIRE FIGHTING MEASURES

  Flammability of Product

  May be combustible at high temperature.

  Auto-ignition Temperature

  N/A

  Flash Point

  N/A

  Flammable Point

  N/A

  Products of Combustion

  These products are carbon oxides (CO, CO2)

  Fire Hazards in Presence of Various Substances

  N/A

  Fire Fighting Media

  Small Fire

  Use DRY chemical powder.

  Large Fire

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

• Section 6 – ACCIDENT RELEASE MEASURES

  Small 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.

  Large Spill

  Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow evacuating through the sanitary system.

• Section 7 – HANDLING AND STORAGE

  Precautions

  Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk; evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust.

  Large Spill

  Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightly closed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme heat and away from strong oxidizing agents.

• 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

  Splash goggles. Synthetic apron. Vapor and dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

  Personal Protection in case of Large Fire

  Splash goggles. Full suit. Vapor and dust respirator. Boots. Gloves. A self-contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

  Exposure Limits

  N/A

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical state and appearance

  Solid

  Color

  A White to off white colour powder

  Odor

  N/A

  Taste

  N/A

  pH

  N/A

  Boiling Point

  N/A

  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

  Freely soluble in acetone, chloroform, Dimethylsulfoxide and ethanol

• Section 10 – STABILITY AND REACTIVITY

  Stability

  The product is stable.

  Instability Temperature

  N/A

  Conditions of Instability

  N/A

  Incompatibility with various substances

  N/A

  Corrosivity

  Non-corrosive in presence of glass.

  Special Remarks on Reactivity

  N/A

  Special Remarks on Corrosivity

  N/A

  Polymerization

  No

• Section 11 – TOXICOLOGICAL INFORMATION

  Routes of Entry

  Ingestion.

  Toxicity to Animals

  LD50

  In mice, rats (mg/kg): >8000

  Orally LC50

  N/A

  Chronic Effects on Humans

  N/A

  Other Toxic Effects on Humans

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

  Special Remarks on Toxicity to Animals

  N/A

  Special Remarks on Chronic Effects on Humans

  N/A

• Section 12 – ECOLOGICAL INFORMATION

  Ecotoxicity

  N/A

  BOD5 and COD

  N/A

  Products of Biodegradation

  Possibly hazardous short term degradation products are not likely.

  Toxicity of the Products of Biodegradation

  The products of degradation are more toxic.

  Special Remarks on the 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 a DOT controlled material (United States).

  Identification

  N/A

  Special Provisions for Transport

  Up to 1month we can keep at atmospheric temp [ambient condition]. If it is more than 1month, better keep the temp 15-30 ° C.

• Section 15 – REGULATORY INFORMATION

  Federal and State Regulations

  TSCA 8(b) inventory

  No products were found.

  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.