Analytical Method Development, Modification, and Validation:

Custom analytical method development and validation using state-of-the-art analytical tools:

  • HPLC (Assay, Impurities/Related compounds, Dissolution, Cleaning validation, Chiral Separation) using Waters Alliance Systems equipped with UV, ELSD, RI, Fluorescence, and Conductivity detectors and Empower software
  • Analytical Methods for non/less chromophore molecules
  • LC/MS/MS (Assay, Impurity identification, Bioanalytical testing)
  • GC and GC/MS (Residual solvents, Assay and Impurities) using Agilent GC equipped with ChemStation software
  • Dissolution testing (solid dosage forms and vitamins)
  • UV/Vis, FTIR, KF and Potentiometric Titration
  • And more .....

Drug Discovery Services

  • Simultaneous analysis for mass and concentration using Waters/MicroMass LC/MS equipped with OpenLynx software
  • New formulation development
  • Evaluation of new formulations
  • Immunoanalytical Testing

Pharmaceutical Drug Testing

  • Raw material, in-process, finished product and stability testing of a variety of pharmaceutical dosage forms
  • Dissolution testing (USP Apparatus I and II)
  • Excipient Testing
  • Polymer Analysis
  • Controlled drug substances schedules II-V
  • Cleaning Validation
  • Quantitative analysis of metals and ions
  • Bioanalytical testing
  • USP/EP/JP Monograph Testing

Testing of Food Products, Food Additives and Fragrances

  • Amino Acids
  • Sugars
  • Vitamins
  • Minerals.
  • Preservatives, flavors and food additives
  • N-Nitrosodimethylamine (NDMA)
  • Melamine and related compounds

Training Services

  • Fundamentals of HPLC and GC
  • Hands-on HPLC training
  • Hands-on GC training
  • Pharmaceutical drug testing methodology
  • Bioanalytical methods
  • Chemicals testing methodology
  • cGMP/FDA/EPA Regulations.

Consulting Services

  • FDA Warning letters Issues
  • Data Review/Auditing Assistance
  • IND/NDA/ANDA filings
  • Quality System
  • Technical troubleshooting