- Analytical R&D and Quality Control
Analytical R&D and Quality Control
- Spectroscopic Capabilities: Structure elucidation of small molecules by Spectroscopic techniques and fluorine and silicon NMR capability. (Using 1D, 2D NMR experiments and MS/MS experiments)
- Chromatographic Capabilities: Purity estimation of NCE’s by Reverse and Normal phase Chromatography and SFC Chromatography for Determination of intermediates, impurities, APIs and enantiomeric excess using variety of chiral columns.
- Purification Capabilities: High Throughput Purification and isolation of compounds (chiral and non chiral) in mg to g scale, for Parallel Medicinal chemistry libraries and singleton compounds. This will be offered in TCG Lifesciences, Kolkata, India.
- GLP Capabilities: GLP analytical lab to conduct Method development and validation as per ICH and OECD guidelines and to support Kilo-lab activity for final release of cGMP material.
- GMP Capabilities: Analytical laboratory (USFDA recognized & NABL accredited) to conduct analytical method validation and followed by analytical method transfer to the manufacturing sites as per regulatory guidelines (ICH/ USP/ EP etc.). Analytical support for DOE/ QbD/ other regulatory submission and prompt support for regulatory queries. Capable of doing short term and long term stability studies of APIs and Intermediates. This will be offered in TCG GreenChem, US and TCG Lifesciences, Hyderabad, India
- Impurity Profiling Capabilities: Isolation and characterization of unknown impurities from APIs and Formulations utilizing the strong skills in preparative isolation and structure elucidation.