Advanced Analytical Services

We offer contract analytical services with ‘State-Of-The Art Instrumentation’.

  • Extractable and Leachable Studies by LC-MS, GC-MS & ICP-MS
  • Genotoxic/Nitrosamine impurities testing by LC-MS & GC-MS
  • Elemental Impurities testing by ICP-MS
  • Analytical Methods Development, Validation and Transfer
  • Glass Delamination Studies
  • IVRT Studies (In-Vitro Release Testing) by Franz Diffusion Cell Apparatus
  • Rheological Studies by Rheometer
  • De-formulation (Q1/Q2 sameness) Studies
  • In-Vitro Phosphate Binding Studies

Analytical Method Development & Validation

  1. Methods using Chromatographic, Mass and ICP MS
  2. Stability indicating methods for drug products and substances
  3. Preservatives
  4. Antioxidants
  5. Cleaning Validation Methods
  6. Method Transfer Activity

Extractable & Leachable Analysis

  1. Controlled extraction studies utilising LC-MS, HS-GC-MS, GC-MS & ICP-MS with data interpretation & extractable screening for both organic compounds & inorganic elements
  2. Determination of AET (analytical evaluation threshold) based on SCT (safety concern threshold).
  3. Development & validation of analytical methods for potential leachable identification & quantification.
  4. Leachable monitoring during shelf life & routine extractable testing
Method Possible Extractable or Leachable
  • HS-GC-MS
Very volatile organic compounds such as solvents, monomers etc.
  • GC-MS
Volatile to semi-volatile organic compounds such as monomers, initiators, oligomers, some antioxidants etc.
  • LC-MS/MS (QTOF)
Medium to higher molecular weight compounds such as antioxidants, plasticisers, lubricants etc.
  • ICP-MS
Elements/ Metals

Impurity Profiling & Characterisation

  1. Genotoxic Impurities/ Nitrosamines Testing in drugs by LC-MS & GC-MS
  2. Organic Volatile Impurities As Per ICH Guidelines
  3. Content By LC-MS & GC-MS
  4. Elemental Impurities By ICP-MS As Per USP<232>, <233> & ICH Q3D
  5. Non-chromophoric Compounds By Using RI, ELSD & MS

Elemental Impurities (ICH Q3D)

De-Formulation Studies & Q1/Q2 Sameness