RJ Lee Group is an ISO-compliant, FDA-registered laboratory with a well-established quality system for pharmaceuticals. Our experts use and develop validated protocols and execute them in a cGMP-level environment to investigate your problem and provide resolution. In addition to investigating your particulate matter, we provide pharmaceutical failure analysis and design a program for future contamination control based on your process. Industrial hygiene, containment, and toxicology services are also available.

Pharmaceutical Services & Capabilities

  • Foreign Particulate Matter (FPM) Analysis
    • Contamination Identification
    • Root Cause Analysis
    • Source Determination
    • Surface Defect Analysis
    • Particular Morphology Evaluation
    • Particle Size Analysis
  • Regulatory Assistance with USP Testing, CAPA Investigations, OOS Investigations
  • Industrial Hygiene, Containment, Validation, and Toxicology Services

Instrumentation & Techniques

  • Fourier Transform Infrared Spectroscopy (FTIR)
  • Scanning Electron Microscopy (SEM)
  • Energy-dispersive X-ray Spectroscopy (EDX)
  • Optical Polarized Light Microscopy (PLM)
  • X-ray Diffraction Microscopy (XRD)
  • Inductively Coupled Plasma Mass Spectrometry (ICP)
  • Gas Chromatography (GC)
  • Raman Microscopy


Submit a Sample & Chain of Custody

Foreign Particulate Matter Analysis