Research and New Technology Development Centre

Reaction Capabilities

Ami Lifesciences has vast experience with reactions from the following classes including scale-up of those reactions to commercial quantities:

  • Acetal Formation
  • Acylation
  • Addition Reaction
  • Aldol Condensation
  • Alkylation
  • Arylation
  • Beckmann Rearrangement
  • Biginelli Reaction
  • Clark-Eschweiler Reductive alkylation
  • Condensation
  • Curtius Rearrangement
  • Cyclization
  • Darzens Glycidic Ester Condensation
  • De-Alkylation Cleavage
  • Decarboxylation
  • Dehydration
  • Esterification / Trans-esterification
  • Formylation
  • Friedel - Craft Reaction
  • Halogenation (Br2, Cl2, I2, ICI, SOCl2, PCl5, PCl3, KF etc.)
  • Knoevenagel Condensation
  • Leuckart Wallach Reaction
  • Oxidation (KmNO4, CrO3, HNO3, O2, H2O2)
  • Perkin Reaction
  • Pinner Synthesis
  • Reduction (H2/Pd, Ni, Pt, NaBH4, Zn, Vitride, Sodium)
  • Sandmeyer Reaction
  • Sarett Oxidation
  • Schiff Base Reaction

Analytical Development Lab Services:

Our analytical departments support the entire product life cycle of active pharmaceutical ingredients with scientific expertise and an extensive technical portfolio. Our core competencies are:

  • Development of analytical methods
  • Optimization of existing analytical methods to optimize robustness or efficiency
  • Validation, verification, and transfers of analytical methods
  • Development-accompanying analyses
  • Release analyses of key starting materials, active pharmaceutical ingredients, and intermediates
  • Production-accompanying in-process controls
  • Cleaning validations
  • Creation of Purity Profiles / Impurity Tracking; Determination of genotoxic impurities
  • Risk considerations and control strategies for elemental impurities for APIs according to ICH Q3D
  • Qualification of reference standards
  • Development of specifications
  • Carrying out stability studies:
  • Stability studies of active pharmaceutical ingredients according to ICH guidelines in certified and controlled climate chambers
  • Stress tests/forced degradation studies including photostability studies

Sophisticated testing laboratory instruments:

  • Chromatography: HPLC, UPLC, GC, GC Headspace
  • Spectroscopy: FT-IR, UV-Vis, XRD, LC-MS, GC-MS, ICP-MS, Microwave digestion
  • Particle Size Distribution: Malvern Mastersizer, Microscopy, Bulk Density and Tap Density Tester
  • Wet chemistry and Pharmacopeial analysis: Cooling Cabinet, Karl Fischer Titrator, Auto Titrator, pH Meter, Turbidity Meter, Halogen Moisture, Melting Point Analyser, Colony Counter, Autoclave, Incubator, Fogger Machine, Anaerobic Culture Jar, Bio-safety Cabinet
  • Other Systems: Mass Detector, Polarimeter, Muffle Furnace, Milli-Q Water Purification, Vacuum Oven, LOD Oven, Glassware Oven, Conductivity and TDS Meter, Ultrasonic Bath, Stability Chambers, Air SamplerM