Analytical Services

UPM’s analytical services group has deep expertise in analytical method development and an understanding of all facets of the drug development process.  As a strategic development partner, we design detailed protocols for method development, validation, and technology transfer based on the product’s phase in the drug development process. Additionally, UPM provides a full range of analytical testing services for raw materials and drug products.

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our services include

 

  • 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 (CI–CV)
  • GC / Headspace Analysis
  • Elemental Impurities
  • Thermal Analysis

UPM Pharmaceuticals offers a vast array of high quality analytical services.


Laboratory Highlights

  • 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
    • 2°C / 8% RH
    • 25°C / 60% RH
    • 30°C / 65% RH
    • 30°C / 75% RH
    • 40°C / 75% RH
    • Photo-Stability 
  • Dissolution Testing
    • Immediate and Extended Release Testing
    • Testing per USP or In-House Methods Using Apparatus I, II, III.
    • Drug Release Testing
    • Auto Sampler Units for Dissolution Profile Studies and Extended Release
  • Key Equipment Highlights
    • 47 – HPLC
    • 4 – UPLC with Dual Wave and PDA Detectors
    • 4 – GC’s with Headspace Analyzers
    • EMPOWER 3- Software for Data Acquisition and Instrument Control
    • FT-IR
    • 2 - Particle Size Analyzers
    • 4 – UV Spectrophotometers
    • 21 – Apparatus I and II Dissolution Baths
    • 2 – Apparatus III Dissolutions Baths
    • 17 – Stability Chambers with a total of 1,600 cubic feet of storage space
    • 3 TOC Analyzers
    • TGA/DSC Calorimetry
    • ICP-Mass Spectrometry

UPM Designs detailed protocols for method development, validation and tech transfer based on the product's phase of development.