Testing Equipment

The DiTEBA laboratory is outfitted with state-of-the-art instrumentation including:

  • Waters Alliance 2690 HPLC  with  PDA, TUV, IR, Florescence, Electro Chemical
    • Waters ACQUITY UPLC System with PDA, TUV, Florescence
  • Waters  ACQUITY TQD UPLC-MS/MS
  • Waters Xevo TQ-S UPLC-MS/MS
  • AA
  • UV, FT-IR
  • Dissolution systems
    • Franz Cell
    • Enhancer Cell systems
  • ELISA readers
  • Capillary & Gel Electrophoresis
  • SDS-Page EP
  • TOC
  • Stability chambers
  • Physical testing equipment (disintegration, friability hardness testing, etc)
  • Particular matter for injectables  

Analytical Testing Equipment

  • Ultra Performance Liquid Chromatography Systems (Waters ACQUITY UPLC System)
  • High Performance Liquid Chromatography Systems (Waters Alliance 2695 HPLC System)
  • UPLC/Tandem Quadrupole Detector LC-MS/MS System (Waters ACQUITY TQD)
  • Detectors:
    • Ultraviolet (UV)
    • Diode array detector (DAD)
    • Fluorescent together with post column derivitization system
    • Refractive index (RI)
    • Electrolytic Conductivity Detector (ELCD)
  • Fourier Transform Infrared Spectroscopy FTIR (Varian FTS-800)
  • Atomic Absorption Spectrometer (Flame, GFAAS) (Varian AA240FS)
  • Gas Chromatography Systems with CombiPAL AS (Varian 3900)
  • USP Dissolution apparatus with fully automated on-line UV/Vis and MultiFill Sample collection module (Hanson SR8-Plus)
  • Franz Diffusion Cell Systems 
  • Total Organic Carbon Analyzer TOC-VCPH system (Shimadzu)
    • with ASI-V, TN, IC, SSM, POC accessory units
  • Particulate measurement system (PMS LS-200)
  • Balances (Mettler Toledo)
  • 836 Titrando (KF/Titration Potentiometric) and Coulometric KF with Tiamo software
  • Conductivity/pH meter (Mettler Toledo)
  • Osmometer (AI 3520)
  • Protein Characterization System (Beckman Coulter ProteomeLab PA800)
  • Wide range of physical testing equipment (Sotax Product, Brookfield)

Bioanalytical Testing Equipment

  • Ultra Performance Liquid Chromatography Systems (Waters ACQUITY UPLC System)
  • High Performance Liquid Chromatography Systems (Waters Alliance 2695 HPLC System)
  • UPLC/Tandem Quadrupole Detector LC-MS/MS System (Waters ACQUITY TQD)
  • ELISA Micro Plate reader (BioTek ELx808IU)
  • Capillary Electrophoresis Protein Characterization System (Beckman Coulter ProteomeLabTM PA 800)

Stability Storage & Testing Equipment

Stability storage room equipped with temperature/humidity and photostability chambers, refrigerators and freezers covering entire ICH recommended range of storage. All the chambers are backed by automated emergency power generator systems for full GMP compliance.

Storage Conditions:

  • 25°C/60% RH
  • 30°C/65% RH
  • 40°C/75% RH
  • 5°C
  • -20°C
  • -80°C
  • Photostability (UV and Daylight)
  • Custom configurations