Topiramate

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.

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