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Home » Products » API Intermediates » Topiramate

Topiramate

Topiramate
Topiramate
Product Code : Topiramate
Brand Name : Rolence
Product Specifications
  • CAS No
  • 97240-79-4
Product Description

 Topiramate

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 ˚C ~130.0˚C
  • Water Content:  NMT 0.5% W/W
  • Specific Optical Rotation at 20 ˚c (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
  • RESIDUAL SOLVENTS
    • 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
  • MICROBIAL ENUMERATION TESTS
    • 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 No 97240-79-4
Molecular Formula C12H21NO8S
Average mass 339.362 Da
Monoisotopic mass 339.098785 Da

ROLENCE PHARMA & CHEMICALS LLP

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