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
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
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
