Analytical Services

Our experts understand the ins and outs of complex regulatory approval and registration processes to help you avoid pitfalls and save time and money.

COMPREHENSIVE VALIDATION SERVICES

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Analytical Support

Pii analytical laboratories work under strict compliance with cGMP/GLP requirements and base our operations on comprehensive SOPs and rigorous quality assurance practices. Our analytical group has extensive experience in method development and validation with a profound understanding of all aspects of the drug-development process. We design and execute detailed protocols for the full method development and validation, verification and transfer — covering procedures for active pharmaceutical ingredients and a wide array of drug formulations.

Below is a brief list of the analytical services Pii offers. For a comprehensive list, contact a Pii Project Ambassador.

Analytical Testing Capabilities

  • Cleaning Method Development, Verification, and Validation
  • Wet Chemistry Analysis
  • HPLC / UPLC testing with a wide variety of detection capabilities (UV, DAD, RI, CAD, ELSD, ECD)
  • Dissolution Testing (USP Apparatus I, II, III)
  • Particle Size Determination by Laser Diffraction
  • GC / Headspace analysis
  • UV/VIS spectrophotometry
  • FTIR spectroscopy
  • Color spectrophotometry

Microbial Analysis:

  • USP testing
  • Sterility
  • Bacterial Endotoxin
  • Particulate Matter
  • Container Closure Integrity Testing (CCIT) by Vacuum Decay
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Analytical Studies

Pii analytical laboratory is designed to perform the following studies in support of all stages of formulation development:

  • Early development stability
  • Excipient compatibility
  • Component compatibility
  • Solubility Screening
  • Thermal cycling and freeze-thaw studies
  • Photostability Studies

Talk to a Pii Scientist