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Analytical Support

PII analytical laboratories work under strict compliance with cGMP/GLP requirements and base their 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 validation, verification and transfer — covering procedures for active pharmaceutical ingredients and wide array of drug formulations.

 

Our analytical services include:

 

  • 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.

 

PII analytical laboratory is designed to perform 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