Etico Lifesciences Analytics has deep expertise and capabilities across a range of dosage forms. Located in the heart of the Hyderabad’s biopharmaceutical sector in Gnome Valley, Shamirpet, Hyderabad.
The training we provide our pharmaceutical contract analysis workforce is second to none, ensuring that our team has the skills to complete your project to the highest standards in the industry. All of our processes are supported by U.S.- and EU- compliant cGMP procedures in conjunction with a robust on-going training program. Our facility and equipment are designed, built, and fully qualified to meet and/or exceed all current regulations and guidance. We are agile, flexible, and always available.
Analytical Method Development & Validation
- Methods using Chromatographic, Mass and ICP MS
- Stability indicating methods for drug products and substances
- 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.|
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