(423) 989-8000     info@upm-inc.com

Analytical Services

UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.  As your strategic development partners, we design detailed protocols for method development, validation, and technology transfer based on the product’s phase in the drug development process.

 

  • UPLC / HPLC capability
  • Dissolution testing
  • Full ICH stability conditions
  • Microbial testing
  • Purity testing
  • Impurity identification
  • Particle size determination by laser
  • Excipient compatibility testing
  • Solubility screening
  • Hygroscopicity studies
  • Methods qualification and validation
  • Controlled drug substances testing (CII–CV)
  • GC / headspace analysis
  • cGMP Laboratory
    14,694 sq. ft. facility

    • QC7 – 5,632 sq. ft.
    • QC11 – 6,296 sq. ft
    • Microbiological Laboratory – Fully Qualified and Functional sq. ft 2,767 sq ft
  • Stability Storage Services
    1,600 sq. ft. per ICH Condition

    • 20°C / 60% RH
    • 30°C / 65% RH
    • 30°C / 75% RH
    • 40°C / 75% RH
    • Photo-Stability Capability
  • Dissolution Testing
    • Immediate and Extended Release Testing
    • Testing per USP or In-House Methods Using Apparatus I, II, III.
    • Drug Release Testing
    • Auto Sampler Equipped Units for Dissolution Profile Studies.
  • Key Equipment Highlights
    • 40 – HPLC
    • 4 – UPLC with Dual Wave and PDA Detectors
    • 6 – GC’s with Headspace Analyzers
    • EMPOWER 3- software for data acquisition and instrument control
    • FT-IR
    • 3 – UV Spectrophotometers
    • 14 – Apparatus I and II Dissolution Baths
    • 4 – Apparatus III Dissolutions Baths
    • 17 – Stability Chambers with a total of 1,600 cubic feet of storage space
    • 2 TOC Analyzers