Quality

Quality Control and Methods Development

Our team provides analytical / microbiological services and quality control to support both development and production covering raw materials, in-process control, intermediate and final product release testing as well as supporting a full complement of stability studies as per ICH guidelines. We also provide analytical method development and validation in accordance with ICH guidelines.

In-house QC Instrumentation Includes:

  • LC-MS
  • HPLCs with UV (PDA) / RI / ELSD detectors
  • GCs: Headspace and direct injection with FID detector
  • Ion Chromatography
  • UV-VIS Spectrophotometer
  • FTIR Spectrometers
  • Karl Fischer and YSI Titrators
  • Optical Activity Polarimeter
  • Total Organic Carbon Analyzer