Quality Control

Ferndale Contract Manufacturing’s Quality Control Laboratory is committed to providing expert and timely analytical chemistry and microbiological testing support. The four departments in our Quality Control Laboratory (Incoming RM, Stability, Finished Product and Microbiology) work together to ensure our clients receive the highest quality services possible.

Managing the quality of a product requires a multi-faceted approach that our highly qualified and efficient in-house labs provide, with services including:

  • Affordable compendia testing according to the USP/NF, EP, BP
  • Customer specified testing in support of raw materials
  • In-process analysis, finished product release and stability testing
  • Development and Validation of stability indicating assays
  • Impurity tracking
  • Analytical R&D support

State of the art instruments and equipment

  • UPLC/HPLC Waters and Perkin Elmer (UV-VIS, PDA, ELSD and RI detectors) Empower chromatography and data handling software
  • GC: Direct injection and headspace capability (Detectors FID and TCD)
  • Malvern Mastersizer 3000 particle size analyzer
  • Brookfield DV-111 cone/plate Rheometer
  • FTIR
  • UV-Vis spectrophotometer
  • GE/Sievers model 900 total organic carbon analyzer (TOC)
  • Melting point analyzer
  • Brookfield viscometer
  • Densitometer
  • Auto-Titrator
  • Refractometer
  • Wet analytical technology (titrations, sulfated ash, residue on ignition, heavy metal, residue on evaporation, LOD and Karl Fischer water determination)