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    Product Specifications
    • 97240-79-4
    Product Description

    Topiramate is an anticonvulsant drug which is prescribed for treatment of chronic lower back pain & epilepsy. It is also most commonly indicated for preventing migraines so as to decrease frequency of attacks. This medicine shows bioavailability of about 80% with protein binding ability of up to 41%. It is consumed orally and gets rapidly absorbed after ingestion. This compound is excreted in urine after elimination half life of up to 25 hours.  Topiramate appears as white to off-white colored powder which shows solubility in methanol & dichloromethane. It has molecular formula C12H21NO8S with molar mass of 339.363 g/mol. 

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

    Other Details:

    • Description: A White to off-white crystlline powder
    • Solubility: Freely soluble in Dichloromethane and soluble in methanol
    • Identification:
      • IR absorption:  The infrared spectrum of the test subtance should concordant with that of standard spectrum
      • HPLC test:  The retention time of the major peak in the chromatogramof the sample preparation corresponds to that of standard.
    • Melting Range:  120.0 ËšC ~130.0ËšC
    • Water Content:  NMT 0.5% W/W
    • Specific Optical Rotation at 20 Ëšc (on anhydrous basis, 0.4% in methanol):  28.0 to -35.0
    • Residue On Ignition: NMT 0.2%
    • Related Substance BY HPLC
      • Fructose: NMT 0.1%
      • Related compound A: NMT 0.1%
      • Topiramate impurity: NMT 0.1%
      • TP2 Compound: NMT 0.1%
      • Any other individual impurity: NMT 0.1%
      • Total impurities: NMT 0.5%
    • Limit of Sulphamate and Sulphate by HPLC
      • Fructose: NMT 0.1%
      • Related compound A: NMT 0.1%
    • Assay by HPLC (on anhydrous basis): 98.0% w/w ~ 102.0% w/w
      • Acetone: NMT 1500 ppm
      • Iso propyl alcohol: NMT 1500 ppm
      • Acetonitrile: NMT 300 ppm
      • Methylene chloride: NMT 250 ppm
      • n- Hexane: NMT 200 ppm
      • Ethyl acetate: NMT 2000 ppm
      • pyridine: NMT 7d ppm
      • other class 1,2,3 residual solvent and other organic solvent: Meets the requirement of other class 1,2 and 3 residual solvents as per USP 467 and no other organic solvents are present
    • Tapped Density: 0.7 g/ml ~ 1.1 g/ml
    • Partical Size (By laser diffraction) D90(Micro meters): 80.0 ~ 350.0
      • Total aerobic microbial count: NMT 1000cfu/g
      • Total combined yeasts and molds count: NMT 1000cfu/g
      • Total combined yeasts and molds count
        • Escherichia coli: Should be absent
        • Salmonella: Should be absent
        • Pseudomonas aeruginosa: Should be absent
        • Staphycoccus aures: Should be absent

    Cas No97240-79-4
    Molecular FormulaC12H21NO8S
    Average mass 339.362 Da
    Monoisotopic mass339.098785 Da
    Contact Us

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    Phone :+918068095345