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Home » Products » API Intermediates » Pregabalin

Pregabalin

Pregabalin
Pregabalin
Product Code : Pregabalin
Brand Name : Rolence
Product Specifications
  • CAS No
  • 148553-50-8
Product Description

Pregabalin API (Active Pharmaceutical Intermediates)

 

IUPAC NAME - (3S)-3-(Aminomethyl)-5-methylhexanoic acid

Other Details:

  • Identification:
    • IR: The IR sprectrum of the sample conform to that of standard
    • HPLC: The retention time of the sample peak should conform to that of standard in enantiomeric
  • X-Ray Powder Difraction Pattern: To match with the working standard
  • ENANTIOMERIC PURITY (PRB-IV : (R-)-(-)3-Aminomethyl-5-methyl hexanoic acid (R-Isomer)):  NMT 0.5%
  • Related Compounds:
    • Purity:  NLT 99.0%
    • Identified impurity
      • PRB-I : (R)-(-)-3- Carbamoylmethyl-5-methyl- hexanoic acid  NMT 0.15%
      • PRB-II : 3-Isobutyl glutaric acid  NMT 0.15%
      • PRB-III : 4 -Isobutyl- pyrrolidin-2-one     NMT 0.15%
      • Largest unidentified impurity    NMT0.10%
      • Total impurity NMT1.0%
  • Assay:  98.0% - 102.0% ( on anhydrous basis and solvent free basis)
  • Residual Solvent:
    • Ethanol  NMT: 5000 PPM
    • Isopropyl alcohol:  NMT 5000 PPM
    • Isobutyl alcohol:  NMT 5000 PPM
    • Ethyl acetate:  NMT 5000 PPM
    • Chloroform:  NMT 60 PPM
    • Triethylamine:  NMT 320 PPM
    • Water Content:    NMT 0.5%
    • Residue On Ignition:    NMT 0.1%
    • Heavy Metals:    NMT 20 ppm

Cas No 148553-50-8
Molecular Formula C8H17NO2
Average mass 159.226 Da
Monoisotopic mass 159.125931 Da

ROLENCE PHARMA & CHEMICALS LLP

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