We can provide you with QC analysis of samples using our extensive range of analytical instrumentation. We help to develop and validate the analytical processes, which includes:
- API Analytical Support
- API Characterization
- Impurity isolation and characterization
- Method validation as per ICH and USP
- Formulation Analytical Support
- Pre formulation studies
- Solid state characterization and polymorphic study
- Method development for both drug substance
- Method validation as per ICH and USP
- Stability studies as per ICH
Below is a list of our analytical instrumentation:
- HPLC (UV detection and ELS detection)
- HRGC (standard injection and headspace sampling)
- LC-MS (Ion-trap)
- FT-IR
- UV spectroscopy
- DSC
- TGA & NMR
- Raman spectroscopy
- XRPD
- DVS
- Hot stage microscope
- Karl Fischer analysis
- Vacuum oven (Loss on drying determinations)
- Muffle oven (sulphated ash / residue on ignition)
- Semi-prep LC
Any of these may be used in the routine QC analysis of drug substances, drug products, starting materials, raw materials and intermediates to GLP / GMP standards if required.
