Analytical & Bioanalytical

Pharmaceutical Research and Development

  • Analytical Method Development and Validation
  • Analytical Method Transfers from Clients
  • Potency/Impurity Assay
  • Drug Substance
  • Drug Products
  • Excipients
  • Dissolution Testing
  • In-Vitro Release Rate Testing (SUPAC)
  • Forced Degradation Studies
  • Stability Indicating Methods
    • Accelerated and Long-term
    • Photostability
  • Impurity and Degradation Product Identification.
 Pharmaceutical Research and Development

Quality Control Release Testing

Quality Control Release Testing
  • USP, BP, EP, JP in-house validated methods or sponsor's methods
  • Raw materials and finished product
  • Organic Volatile Impurities/Residual Solvents
  • API and Drug Product Release testing
  • Cleaning Validation/Verification testing
  • Dissolution testing
  • Preservative effectiveness testing

Bioanalytical and Bioassay

  • Assay method development, validation and transfers
  • Sample analysis technologies in multiple biological species and matrices
  • Metabolite identification using LC/MS/MS
  • Expertise in many proven validated methods to quantitatively measure all types of compounds(small or large molecule), using LC/MS/MS, UPLC/MS/MS, HPLC, UPLC and immunochemistry (Elisa);
  • Feasibility assessments
  • HPLC, UPLC, LC/MS/MS , UPLC/MS/MS bioanalysis of drug and metabolites in biological fluids from pre-clinical and clinical trials
 Bioanalytical and Bioassay