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Analytical method development & validation

Phase-appropriate analytical methods

Phase-appropriate analytical methods using complementing techniques

Sai Life Sciences brings over a decade of experience and successful track record in developing phase appropriate analytical methods and validations for NCEs and commercial APIs.

Why work with Sai?

  • 250+ projects delivered across globe for large pharma and biotech companies.
  • Harmonised practices within the department resulted greater than 90% of RFT in developing the methods for fit for the purpose.
  • Experienced and diversified skill set 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 and to get the real time analysis
  • Harmonised method development approach for building accurate, robust and efficient analytical methods.
  • Impurity profiling and structural characterization
  • Expertise in developing the GTIs and Nitrosamine sensitive methods.
  • Expertise to deliver the solid state characterization activities.
  • Proven team in developing the chromatographic purification technology from gram to multi 100 kg scale.

How does it work?

Our AR&D team have a thorough understanding of latest regulatory requirements, relevant chemistry and analytical techniques that are critical in developing efficient, accurate, robust analytical methods by systematic approach.

The analysts interact closely with chemists to understand the process requirements 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 methods. Special emphasis is placed on the first critical activity, sampling, and sample preparation, for accurate estimation. The team has rich experience in developing methods for chiral compounds, non-chromophoric compounds, and expertise in developing the sensitive methods for Genotoxic impurities (GTI) and Nitrosamines as well as handling complex sample metrics and high molecular weight substances. The structural identification and characterization of the compounds is integral part of the analytical method development.

The analytical methods are validated by dedicated qualified team as per phase appropriate requirements and ICH norms under GMP with QA supervision. In the process of analytical method validation, team will execute the activities in line with client requirements including protocols and reports 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

  • Nucleosides
  • Amidites
  • Lipids
  • Carbohydrates
  • Natural Products
  • Peptides
  • Non-chromophoric compounds
  • Highly hygroscopic as well as volatile compounds

Partial list of analytical instruments

  • HPLC/ UPLC H with PDA, UV, ELSD and RI, CAD detectors
  • LC-MS/MS/Trap & GC-MS/MS/Trap
  • ICP – MS
  • NMR (400 and 500 MHz)
  • GC with Head-space – FID, TCD & ECD
  • SFC – Analytical & Preparative
  • Preparative HPLC
  • DSC, DVS & TGA
  • FT-IR
  • Volumetric and Coulometric KF
  • UV-Vis spectrophotometer
  • Auto titrator
  • Ion Chromatography with Conductivity & Ampirometric detectors
  • Polarimeter
  • pXRD
  • Microscopy
  • Malvern Mastersizer 3000 (PSD)

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