Pregabalin

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PREGABALIN Therapeutic Category Anticonvulsant Grade BP/EP/USP ISO 90012008  PregabalinTherapeutic Category Anticonvulsant Grade BP/EP/USPWe offer PREGABALINE Our Quality is according to latest pharmacopeia                                                                                       PREGABALINEDescriptionA white to off white crystalline powderSolubilityFreely soluble in dilute HCl Sparingly soluble in waterIdentificationa)      By IR        b)   By HPLC                              By IR spectrum the infrared absorption spectrum of the test sample exhibits maxima only at the sample wavelength as that of the working standard.Retention time of the principal peak in the chromatogram obtained with sample solution should match with that of the principal peak in chromatogram obtained with standard solutionLoss on drying (At 75°C for 3 hrs.)NMT 0.50%Melting Rangeshould between 180°C and 188°COptical  rotationShould be between +10.0° and +12.0°Residue on ignitionNMT 0.10%w/wHeavy metalsNMT 20ppmMandalic acid  contentNMT 0.1%Related substances(by HPLC)a) Max. individual impurity     NMT 0.50%b) Total impurities                     NMT 1.0%Assay on anhydWWe offer PREGABALINE                                                                                               PREGABALINE   DescriptionA white to off white crystalline powderSolubilityFreely soluble in dilute HCl Sparingly soluble in waterIdentificationa)      By IR        b)   By HPLC                              By IR spectrum the infrared absorption spectrum of the test sample exhibits maxima only at the sample wavelength as that of the working standard.Retention time of the principal peak in the chromatogram obtained with sample solution should match with that of the principal peak in chromatogram obtained with standard solutionLoss on drying (At 75°C for 3 hrs.)NMT 0.50%Melting Rangeshould between 180°C and 188°COptical  rotationShould be between +10.0° and +12.0°Residue on ignitionNMT 0.10%w/wHeavy metalsNMT 20ppmMandalic acid  contentNMT 0.1%Related substances(by HPLC)a) Max. individual impurity     NMT 0.50%b) Total impurities                     NMT 1.0%Assay on anhydrous basis(by HPLC)between 98.0% and 101.0% w/wParticle size100% passes through 80 mesh