Pharmaceutical Analytical Services
Pii’s pharma analytical experts understand the complexities of regulatory approval and registration processes related to analytical stability, method development, phase-appropriate validation, and drug product testing to help you avoid pitfalls.
COMPREHENSIVE ANALYTICAL SERVICES
Pharmaceutical Analytical Support
Pii analytical laboratories work under strict compliance with cGMP/GLP requirements and our operations are based on comprehensive SOPs and rigorous quality assurance practices. Pii’s analytical team has extensive experience in analytical method development and validation, drug product release testing, and stability testing support. We have extensive understanding of all aspects of the phase-appropriate regulatory requirements to support the drug development process. We design and execute detailed protocols for full analytical method development and phase-appropriate validation, verification or transfer — covering procedures for active pharmaceutical ingredients and a wide array of drug formulations.
Below are just some of the analytical services Pii offers. For a comprehensive list, contact a Pii Project Ambassador.
Analytical Testing Capabilities (R&D and QC)
- Cleaning Method Development, Verification, and Validation
- Wet Chemistry Analysis
- HPLC/UPLC Analytical method development/validation/testing with a variety of detection capabilities (UV, DAD, RI, CAD, ELSD, ECD)
- Dissolution Testing (USP Apparatus I, II, IV)
- Particle Size Determination by Laser Diffraction (Malvern 3000 and Zetasizer Nano)
- GC/Headspace Analysis
- UV/VIS Spectrophotometry
- FTIR Spectroscopy
- Elemental Impurities (ICP-MS)
- Color Instrumental Measurement (Hunter Lab UltraScan Vis)
- Break Loose/Glide Force Testing for prefilled syringes (Instron Model 3342)
- Scanning Electron Microscopy (SEM)
- Differential Scanning Calorimetry (DSC)
- TOC Analysis
Microbial Analysis
- USP Testing (Microbial Enumeration <61>, Test for Specified Organisms <62> and Antimicrobial Effectiveness Testing <51>)
- Sterility Testing <71>
- Bacterial Endotoxin <85>
- Particulate Matter in Injections <788>
- Container Closure Integrity Testing (CCIT) by Vacuum Decay <1207>
Stability Storage and Testing
Pii can support your clinical or commercial stability programs for both API and drug products, including injectables, oral solids, and liquids. Stability management includes protocol preparation, storage under required ICH guidelines, testing (both analytical and micro), and provision of final submission ready reports. Our team understands the importance of stability programs, and timely testing, and data reporting. We will closely monitor your project from initial set-down to final testing for the duration of the study.
Analytical Studies
Pii’s R&D analytical laboratories are designed to perform the following studies in support of all stages of formulation development:
- Early development formulation stability
- Excipient compatibility
- Component compatibility
- Solubility screening
- Thermal cycling and freeze-thaw studies
- Photostability studies
- In-use stability studies
Specialized Analytical Equipment and Applications
Pii proudly has the following equipment on-site to carry out your analytical testing:
- Ion Chromatography (IC) with suppression for the precise and sensitive detection of inorganic ions in a complex matrix
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for the determination of very low-level multi-elements in a complex matrix fulfills requirements to comply with ICH Q3D Guideline for Elemental Impurities
- Dissolution Apparatus IV (Flow-through-Cell) for dissolution of poorly soluble drugs and extended-release products
Pii’s full-service analytical team can assist you with your project using our Concept-to-Clinic-to-Commercialization Pharmaceutics Know-How™.
