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Analytical Research & Development
Comparative Dissolution Profile
Comparative Dissolution Profile:
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
Method Development:
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

Method Validation as Per ICH
Method Validation as Per ICH:
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 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
Method Transfer / Verifications
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