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ANALYTICAL RESEARCH |
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Capabilities |
- Development of analytical methods to test starting materials, intermediates
APIs and finished dosages
- Validation of analytical test methods as per ICH guidlines
- Characterization and standardization of reference
standards
- Characterization of proteins and peptides
- Impurity profiling, polymorph testing and stability studies of APIs
- Pre-formulation and dissolution studies
- Analytical test methods transfer
- Support to the Regulatory Department by provision of data, documents and reports for regulatory submissions for domestic and international product registrations ( EU-DMFs, US-DMFs, ANDAs and dossiers)
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| Infrastructure |
- HPLCs
- LC/MS/MS
- GCs
- GC MS
- Ion Chromatography
- NMR
- UV-Vis and FTIR Spectrophotometers
- X-ray Diffractometer
- Autotitrators
- CHNS and O analyser
- Amino acid analyzer
- DSC
- TGA
- HPTLC
- CZE
- Automated dissolution testers
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