cGMP ANALYTICAL SERVICES

Analytical Services Overview

Salubrent’s analytical method development, method validation, and testing solutions combine with a full complement of our advanced analytical and information technologies to deliver the industry’s best offering.

Salubrent’s data collection seamlessly integrates into our project management and quality assurance systems. Our analytical laboratories include the ability to customize data flows on the fly and are strategically arranged to maximize efficiency and deliver results.

We offer the flexibility to be your analytical development arm or to provide the analytical support you need for your existing development program.

Analytical Development

  • Drug product comparator studies
  • Extractability and leachability studies
  • In-use and administration set compatibility studies
  • Material contact studies
  • Physical and structural chemistry
  • Early method development


Analytical Validation

  • Drug product comparator studies
  • Cleaning method verification and validation
  • Phospholipid and fatty acid analysis
  • Process validation support
  • Related substances, chiral purity, elemental impurity, and residual solvent analysis
  • Remedial method validation


Analytical Testing

  • Dissolution method development and testing: UV and HPLC
  • Drug substance/drug product stability indicating assays
  • Drug substance/reference standard material characterization
  • Preservative and stabilizing excipients assays
  • Reference standard qualification
  • HPLC method development and testing
  • Gas chromatography (GC)
  • Wet chemistry testing
  • Container closure integrity testing
  • Particulate matter in injections (USP <788>)
  • Endotoxin testing (USP <85>)
  • Total aerobic microbial count (USP <61>)
  • Total yeast and mold count (USP <61>)


ICH Stability Testing Services

  • 2-8C
  • 25C
  • 40C

Analytical Lab | Kannapolis, NC

Collocated with our API partner, Bright Path Labs, our first analytical lab is located at the North Carolina Research Campus in Kannapolis, NC (a short drive from Charlotte International Airport) where we are providing comprehensive analytical services in some of the newest and most modern laboratory facilities in North Carolina.

NC Research Campus Lab – Key Capabilities:

  • Three on-site walk-in stability chambers totaling 1,000 sq. ft.
    • 25◦C /40RH; 40◦C /65RH; 4◦C
    • Additional reach-in chambers will be added to meet customer-specific needs
    • Stability Test Request Form
  • Full-service capabilities for analytical development & testing
    • Stability testing for all clinical phases and finished drug product
    • HPLC/UPLC method development & testing
    • Gas chromatography
    • Dissolution method & testing
    • Particle size distribution evaluation
    • Reference standard qualification & program management
    • Drug substance & reference standard material characterization
    • ELISA
    • Click here to download our Capabilities presentation
Analytical Equipment:

  • Perkin-Elmer Clarus 600 GC/MS System
  • Agilent Network Gas Chromatograph System 6890N with FID & TCD Detectors & Network Headspace Sampler System
  • Agilent Technologies Infinity 1260/1290 HPLC Systems
  • UV-Visible Spectrophotometer Agilent Technologies Cary8454
  • FT-IR Spectrophotometer Thermo Electron Nicolet 380 FT-IR Spectrophotometer
  • UPLC
  • Karl Fischer Titrators
  • Mastersizer Laser Diffraction Particle Size Malvern Instruments
  • UV-Visible Online Spectrophotometer Agilent Technologies
  • Sotax AT7 Smart Semi-Automated Dissolution Systems
  • Spectromax ABS Plus UV/VIS Microplate Reader
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