Process development work for the Active Pharmaceutical Ingredients (APIs) is carried out by the Chemical Process Research Laboratory, which focuses on developing commercially viable eco-friendly processes for intermediates and APIs for the regulated global markets.
| Capabilities |
Chemistry |
- Heterocyclic chemistry
- Catalytic hydrogenations
- Organic transformations of wide and varied types
- Classical and dynamic resolutions
- Asymmetric synthesis using chiral pool, enantio /diastereo-selective
reactions
- Polymer Chemistry
- Green chemistry
- Biocatalysis
|
Process |
- Development of novel/non-infringing processes for
APIs
- Development of environment friendly processes
- Development of Chiral APIs
- Ability to comply with ICH guidelines
- Synthesis, isolation and characterization
of impurities
- Expertise in handling pyrophoric reagents
- Expertise in very low temperature (-85
deg C) reactions
|
Analytical |
- Development of in-process analytical methods
- Isolation and identification of impurities
- Enantiomer separation using chiral HPLC/GC
columns
- Preparative TLC/HPLC
|
Polymorphism |
- Synthesis of novel Polymorphs
- Synthesis of amorphous forms using lyophilization, spray drying or solvent evaporation techniques
- Development of novel processes for known
Polymorphs
- Quantification studies of Polymorphs using
IR/DSC/XRPD
- Determination of Polymorph stability
|
| Achievements |
| Total portfolio of 50 APIs
|
- Processes for 38 APIs developed
- 21 processes validated
- 12 under development
|
| Infrastructure |
- Modern laboratory supported by state-of-the-art
instrumentation facility
- On-line search facilities for information
mining
- 1 to 25 L capacity high pressure SS/Glass/Hastalloy
autoclaves
- Parallel synthesizer with calorimetric
probe
- GCs, HPLCs
- Micronisation facilities to obtain particle
size right from <5
- Surface area determination
- X-ray crystallographic capabilities for
polymorphism studies
- Multipurpose plant with a combination
of 21 GLR and SS reactors
- Preparative scale HPLC
|
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