Analytical method development & validation
Phase-appropriate analytical methods using complementing techniques
Sai Life Sciences brings over a decade of experience and successful track record in developing compliant yet clinical phase appropriate analytical methods and validations for NCEs.
Why work with Sai?
- 125+ projects delivered across globe for large pharma and biotech companies
- Experienced team, well-versed with relevant global guidelines and customers expectations
- Appropriate use of complementing analytical techniques
- Satellite analytical labs (within chemistry labs) for constant and closer interaction with chemists
- Common method approach for building efficiency within the analytical method
How does it work?
Our AR&D teams have a thorough understanding of latest regulatory requirements, relevant chemistry and analytical techniques that are critical in developing efficient, accurate, reliable analytical methods.
The analysts interact closely with chemists to understand the requirement, process changes with respect to mole equivalents of RMs, dilutions, sensitivity / stability of reagents, intermediates and products and swiftly develop ‘fit for the purpose’ analytical method. Special emphasis is placed on the first critical activity, sampling and sample preparation, for accurate estimation. The team has extensive experience in developing methods for chiral compounds, non-chromophoric compounds, identification of Genotoxic impurities (GTI) as well as handling complex sample metrics and high molecular weight substances. Structure identification and confirmation of intermediates and impurities is integral part of the analytical method development.
The analytical method is validated by a separate and dedicated team under QA guidance and supervision. The comprehensive analytical method validation protocols, as per relevant regulatory guidelines and work plans are prepared by validation team, followed by review and approval by QA. Depending upon the project scope, the protocols are also shared with customer, for their review and approval.
The teams continuously interact with the customer during the entire project span and even beyond for the ongoing stability studies.
Diverse complexity profile of compounds
- Natural Products
- Peptides and several non-chromophoric compounds
- Highly hygroscopic as well as volatile compounds
Partial list of analytical instruments
- HPLC with PDA, UV, ELSD and RI, CAD detectors
- LC-MS/MS & GC-MS
- ICP – MS
- NMR (400 and 500 MHz)
- GC with Head-space – FID, TCD & ECD
- SFC – Analytical & Preparative
- Preparative HPLC
- DSC & TGA
- KF Auto titrator
- UV spectrophotometer
- Ion Chromatography with Conductivity & Ampirometric detectors