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