API R&D

Analytical and Quality Control

Our analytical and quality control capabilities far exceed our industry peers.

API Manufacturing and cGMP Polymer Manufacturing

PCI has developed an advanced analytical capability that differentiates us from others in the industry.  It’s not only the latest advanced equipment but also the experienced organization we have built that helps to support all of our synthesis programs.

As a leading supplier to the Life Science Industry, PCI Synthesis recognizes the importance of adhering to the highest standards for quality; cooperate to set specifications; develop, validate, and operate robust analytical procedures; sample, test, and control all raw materials, intermediates and final products; analytical support for all manufacturing operations; disposition and distribution of manufactured products and in-house stability program

Move the following:

Through a cooperative agreement with local universities such as Clark University in Worcester, MA, PCI also provides advanced non-GMP testing techniques including:

  • Atomic Absorption (flame and graphite) spectroscopy
  • X-ray Crystallography
  • Nuclear Magnetic Resonance Spectroscopy
  • Differential Scanning Calorimetry
  • Mass Spectroscopy

Our analytical department is fully compliant with CFR Part II and all in process testing, method development, method qualification and method validation are done in house by our experienced team of analysts and analytical development scientists.

PCI Synthesis employs the most advanced analytical techniques available, these include:

  • GC and GC Headspace Systems
  • UPLC Systems (Ultra High Pressure Liquid Chromatrography)
  • HPLC Systems Equipped with UV-VIS, DAD, CAD and RID
  • Ion Chromatography
  • Gel Permeation Chromatography
  • Malvern Particle Size Analyzer
  • UV-VIS, FTIR
  • Total Organic Carbon Analysis (TOC)
  • Polarimeter and Turbidimeter and Viscometer
  • Heat Stability and Aging Tests
  • A wide array of Wet Chemistry Analyses
  • Auto Titration
  • Tap Density and Melting Point
  • Karl Fischer (KF)
  • LCMS
  • GCMS