Our Analytical Methods Laboratory provides analytical support to our R&D laboratories through documentation and validation of test results as per ICH guidelines

Capabilities

• Development of analytical methods to test starting materials, intermediates APIs and finished dosages
• Validation of analytical test methods as per ICH guidelines
• 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)

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