PHARMACEUTICALS

SERVICES

  • Method Development and Validations
  • Extractable and Leachable Studies
  • Dissolution Studies
  • Elemental Impurity Studies
  • Genotoxic Impurity Studies
  • Raw Material and Excipient Analysis
    Packaging Material Testing
  • Pharmacopeia Compendial Testing
  • Stability Studies
  • Microbiological Testing
  • Water Testing
  • Biological Studies

Method Development and Validation

  • Analytical method development and validation is a critical modules of any pharmaceutical development program using appropriate procedure for the qualitative and quantitative valuation through the formation of product specification and its shelf life.
  • Validated methods establish clear restrictions of application by verifying the process is robust enough so that the negligible deviations between operators or between laboratories do not have an influence on upshots.
  • Analytical method development and validation services are performed as per ICH Q2, USP <1225>, method verifications as per <1226>, and/or customer necessities.
  • Umed pharma provide identification, Assay, Related substance, Dissolution, Content uniformity, Residual solvents, Particle size distribution, and Elemental Analysis (Q3D) etc.
  • Techniques used are HPLC (UV, RI, PDA), GC-HS (FID, ECD), Dissolution Apparatus, pXRD, PSA, GC-MS/MS, HS-GC-MS, LCMS, ICPMS and AAS.

Analytical method development and validation testing on different pharmaceuticals:

  • Active Pharmaceutical Ingredients (APIs) / Drug Substance
  • Drug Products (Tablets, Capsules, Injectables, Syrups, Suspensions, & Emulsion etc.,)
  • Raw Materials
  • Key starting materials (KSM)
  • Intermediates
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