We offer contract analytical services with ‘State-Of-The Art Instrumentation’.
- Extractable and Leachable Studies by LC-MS, GC-MS & ICP-MS
- Genotoxic/Nitrosamine impurities testing by LC-MS & GC-MS
- Elemental Impurities testing by ICP-MS
- Analytical Methods Development, Validation and Transfer
- Glass Delamination Studies
- IVRT Studies (In-Vitro Release Testing) by Franz Diffusion Cell Apparatus
- Rheological Studies by Rheometer
- De-formulation (Q1/Q2 sameness) Studies
- In-Vitro Phosphate Binding Studies
Analytical Method Development & Validation
- Methods using Chromatographic, Mass and ICP MS
- Stability indicating methods for drug products and substances
- Preservatives
- Antioxidants
- Cleaning Validation Methods
- Method Transfer Activity
Extractable & Leachable Analysis
- Controlled extraction studies utilising LC-MS, HS-GC-MS, GC-MS & ICP-MS with data interpretation & extractable screening for both organic compounds & inorganic elements
- Determination of AET (analytical evaluation threshold) based on SCT (safety concern threshold).
- Development & validation of analytical methods for potential leachable identification & quantification.
- Leachable monitoring during shelf life & routine extractable testing
| Method | Possible Extractable or Leachable |
|
Very volatile organic compounds such as solvents, monomers etc. |
|
Volatile to semi-volatile organic compounds such as monomers, initiators, oligomers, some antioxidants etc. |
|
Medium to higher molecular weight compounds such as antioxidants, plasticisers, lubricants etc. |
|
Elements/ Metals |
Impurity Profiling & Characterisation
- Genotoxic Impurities/ Nitrosamines Testing in drugs by LC-MS & GC-MS
- Organic Volatile Impurities As Per ICH Guidelines
- Content By LC-MS & GC-MS
- Elemental Impurities By ICP-MS As Per USP<232>, <233> & ICH Q3D
- Non-chromophoric Compounds By Using RI, ELSD & MS