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

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

ADVANCED INSTRUMENTATION – ANALYTICAL R&D

S.No. Name of the Equipment Make Model Specification
1 LC- MS/MS (HRMS-QTOF) Agilent 6550 (i-funnel) Capable of handling Mol. Wt. 10,000 Daltons (without deconvolution)
2 2D HPLC Agilent 1290 infinity II With PDA & VWD detectors
3 GC – MS Agilent 5977 B With FID & Mass detectors
4 ICP – MS Agilent 7800 With Solvent handling Kit
AD4
AD3
AD2