API Method Development & Validation
- Stability-indicating assay and impurities method using column screening technology
- Chiral method development using column screening technology
- Residual solvent analysis by GC or GC-HS
- Water content analysis by KF
- Mutagen/structure alert/PGI by LC-MS, LC-MS/MS and GC-MS
- Counter-ion method development by titration/IC etc.
- Trace metals (Pd, Cs, etc. ) by ICP-OES/ICP-MS
- NMR – quantitative assay or ID test
Drug Product Method Development & Validation
- Potency and related substance method; content uniformity/blend uniformity
- Dissolution method for formulation screening or QC release
- Method development for products containing multiple APIs and assisted by impurity identification by LC-MS-MS/NMR
GMP Release of API/Drug Product
GLP Release of API
- LC-TOF-MS, LC-MS/MS and NMR as standard technique platform
- Sample enrichment by separation and structure verification using pure standards
Confirmation of Structure (COS)
- NMR, accurate MS, IR, UV, elemental analysis, optical rotation etc.
- Full characterization with chromatographic purity, assay, ROI, LOD, water by KF, residual solvents, ID by NMR/IR etc.
- ID by IR or full release as per USP/EP/ChP
Elemental Impurities by ICP-MS