Product Evaluation



Physical Test:


Test Parameter

  • Uniformity of Weight / Weight Variation
  • Uniformity of Dosage Units (by weight)
  • Uniformity of Dispersion
  • Diameter / Thickness / Length / Width (For each )
  • Hardness
  • Disintegration test
  • Friability test
  • Loss on Drying / LOD
  • Dispersion
  • Bulk density
  • Jelly strength
  • More....


    Chemical Test:


    Test Parameter

  • Loss on Ignition / sup hated Ash
  • Heavy metals
  • Arsenic
  • Melting point / melting range
  • Acidity / alkalinity
  • Total hardness
  • Total dissolved solids
  • Color / Clarity of Solution (Chemical)
  • Chlorides, by Titration
  • Chlorides (qualitative test)
  • More....


    Instrumental Test:


    Test Parameter

  • Identification by HPLC -UV detector
  • Identification by HPLC -RI detector
  • Identification by GC-FID detector
  • Amino acid analysis by HPLC-UV detector
  • Identification by IR
  • Identification by TLC
  • Identification by UV
  • Optical Rotation by Digital Polari meter (Specific optical rotation)
  • Assay by HPLC -UV detector (for one active)
  • Assay by HPLC -RI detector ( for one active)
  • More....


    Test Parameter

  • Development of discriminating dissolution Method by HPLC per media
  • Development of Discriminating Dissolution Method by UV per media
  • CDP (Test & Reference),multiple Time Points up to multiple media, BY HPLC
  • CDP (Test & Reference), multiple Time Points up to multiple media, BY UV
  • Comparative Dissolution Profile:




    Test Parameter

  • Method Development for Assay / UOC by HPLC
  • Method Development for Assay / UOC by UV
  • Method Development for Dissolution by HPLC
  • Method Development for Dissolution by UV
  • Method Development for Related Substances / Compounds by HPLC
  • Forced Degradation, by HPLC
  • CDP (Test & Reference), multiple Time Points up to multiple media, BY UV
  • Method Development:




    Test Parameter

  • Method validation for Assay by HPLC, with Forced Degradation
  • Method validation for Assay by HPLC, without Forced Degradation
  • Method validation for Dissolution / Preservative Content / Content by HPLC
  • Method validation for Assay / Dissolution / Preservative Content / Content by UV
  • Method validation for Related Substances / Compounds by HPLC, with Forced Degradation
  • Method validation for Related Substances / Compounds by HPLC, without Forced Degradation
  • Method validation by GC
  • Method Validation as Per ICH:




    Method Transfer/ Verifications :


    Test Parameter

  • Assay by HPLC
  • Assay by UV / Chemical
  • Assay by Microbiology / Antibiotic Assay
  • Dissolution by HPLC
  • Dissolution by UV
  • Related Substances / Compounds by HPLC


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