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Pregabalin

Pregabalin
Pregabalin
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Product Code : 04
Brand Name : Rolence
Price And Quantity
  • Price
  • Approx Price: Rs 3,500 /Kilogram INR
Product Specifications
  • CAS No
  • 148553-50-8
Product Description

Pregabalin is medicinal compound which belongs to garbapentinoid class of drugs and has chemical formula C8H17NO2 with molecular weight of 159.226 g/mol. It is prescribed for treatment of neuropathic pain, restless leg syndrome, and generalized anxiety disorder. This compound is highly effective in nature and is known to work by inhibiting calcium channels. It serves as inhibitor of alpha-2 omega subunit-containing VDCCs and assures targeted mode of action. Pregabalin gets rapidly absorbed after ingestion with bioavailability of about 90% and elimination half life of 6.3 to 11.5 hours. It is also indicated as supportive therapy for partial seizures.

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

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ROLENCE PHARMA & CHEMICALS LLP
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Mobile :+918068095345
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