Analytical Research & Development

With top-of-the-line cGMP facilities and instrumentation, as well as experienced scientists, Kashiv Pharma offers a full array of analytical services, including early state product characterization, analytical method development/validation, product release, and stability testing.

Highlights of our Analytical Services

  • Physical and chemical characterization of the drug substance
  • Analytical method development and validation
  • Excipient compatibility studies
  • Impurities/degradation product characterization and identification
  • Raw materials and finished products testing and release
  • Finished product stability testing
  • Discriminating dissolution method development
  • Manufacturing equipment cleaning verification method development and testing
  • Residual solvents method development and testing
  • Trace metals analysis
  • IV-IVR and PK simulation
  • Cleaning swab testing for equipment residue and detergent

Instrumentation

  • HPLC with UV, PDA, Fluorescence, CAD, and Reflective Index detectors
  • GC with headspace autosamplers
  • USP dissolution – apparatus I, II, III & IV
  • Malvern Mastersizer 2000
  • Karl Fischer coulometric and titrimetric titrators
  • Potentiometric titrators
  • FTIR spectrophotometer
  • UV-visible spectrophotometers
  • LC-MS and GC-MS
  • ICP-OES
  • uPLC