Analytical Services

At Videti, a premier Contract research and development organization (CRDO), our analytical services ensure accuracy, precision, and full regulatory compliance in drug substances and products.We specialize in method development and validation for quantification, impurity profiling, and stability testing—supporting global regulatory submissions and accelerating development timelines.

 

  • Purity, Identity & Stability Testing: Purity, identity, and stability verified through advanced analytical techniques, with rigorous release and shelf-life studies ensuring long-term product efficacy and safety.(Combine)
  • Impurity Profiling: Identifying and quantifying trace impurities to meet strict regulatory standards
  • Solid-State Characterization: Examining crystalline structure and polymorphism to optimize solubility and bioavailability.
  • Polymorph & Salt Screening: Identifying optimal forms for improved solubility and manufacturing scalability.
  • Particle Size & Morphology Studies: Assessing particle distribution and morphology to ensure consistent formulation.
  • Crystallinity & Hygroscopicity Analysis: Evaluating material behavior under various storage conditions for stability assurance.
  • Excipient Compatibility Studies: Ensuring excipient interactions support formulation stability and patient safety.
  • These services form a robust foundation for delivering safe, effective, and globally compliant drug products.

Advanced Instrumentation:

 Spectrometry:

  • FT-IR: Identifies material/molecule’s functional groups.
  • UV-Vis: Quantifies and characterizes compounds via absorption spectra.
  • NMR: Proton and 13C
  • LC/GC-MS: High-resolution analytical technique that combines physical separation by LC fallowed by mass analysis.
  • ICP-MS: Ultra-sensitive elemental analysis at ppb/ppt levels.
  • AAS: Measures elemental concentration in a sample at ppm level

Analytical Instruments:

  • X-ray diffraction (XRD): Analytical technique used to determine the crystallographic structures of materials.
  • DSC & TGA: Assesses thermal behavior and stability.
  • PSA: Measures particle size distribution.
  • SEM with EDS: Examines surface morphology and elemental composition.
  • Optical Microscopy: High-resolution visualization of microstructures.
  • Amino Acid Analyzers: Quantifies amino acids for protein/peptide profiling.
  • Karl Fischer Titration: Accurately measures moisture content.
  • Polarimeter: Determines optical rotation of chiral molecules.