Stand-Alone Contract Analytical Services

Pii’s pharmaceutical analytical experts understand the complexities of regulatory approval and registration processes. Our analytical assets and capabilities are offered as part of our Concept-to-Clinic-to-Commercialization Pharmaceutics Know-How™. And now our stand-alone contract analytical services give you access to Pii’s analytical stability, method development, phase-appropriate validation, and drug product testing.

COMPREHENSIVE Stand-Alone Contract ANALYTICAL SERVICES

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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.

Do you have a question about analytical testing or drug validation? Click here to speak with our team.

Talk to a Pii Scientist Today About Your Stand-Alone Contract Analytical Needs:

Stand-Alone Contract Analytical Testing Capabilities (R&D and cGMP)

  • 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)
    • CAD, ELSD, ECD are not available for stand-alone contract services
  • 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) (For non-GMP activities)
  • Differential Scanning Calorimetry (DSC)
  • TOC Analysis

Microbial Analysis

(Not available for stand-alone contract service)

  • 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>
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READ OUR LATEST ARTICLE:
Outsourcing Analytical Testing is a Money Saver
By: Rahul Mehta, MSc, Associate Director
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Early-Stage Analytical Development is in Pii’s DNA

 
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Stand-Alone Contract 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.

Stand-Alone Contract 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

Contact Pii For Your Next Stand-Alone Contract Analytical Needs

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 (not available for contract analytical services)
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for determination of very low-level multi-elements in a complex matrix. This is widely used to fulfill 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™.

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Click here to connect with a Pii analytical expert.

Talk to a Pii Scientist Today About Your Stand-Alone Contract Analytical Needs