• Injectable-Delivery-Systems-HPLC

Focused Analytical Services

Our team engages with customers to define the characteristics of elastomeric component that are best suited your drug product. We will assess functionality for intended use, extractables and leachables, and physical chemical compatibility. We provide dedicated support for migration studies with placebo or active drug to help you identify potential leachables and to optimize your formulation. We keep progress moving forward through stability studies, regulatory approval and post-market approval.

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Product Life Cycle Support

Component Selection Package

  • Review Extractables Data Package
  • Component Qualification Strategy
  • Technical Assessment Report

Pharmaceutical Development

  • Customized Extraction Study
  • Migration Study
  • Formulation Stability
  • Risk Assessment Report
  • Closure Functionality
  • Container Closure Integrity

Regulatory Support

  • Leachable study performed on stability
  • Sub-visible and Visible Particle Size Analysis
  • Particle Identification
  • Forensic Analysis
  • Compendial Testing
  • Component Change Control Studies
  • Regulatory Support

Instrumentation

  • LC-MS
  • GC-MS
  • GC-HS
  • HPLC-UV
  • HPLC-PDA
  • UPLC
  • Ion Chromatography
  • ICP-MS
  • FTIR
  • Polarized Light Microscope
  • HIAC
  • Raman/LIBS
  • SEM-EDS

Component Reference

  • Coated Stoppers

  • 13 & 20 mm stoppers

  • Serum stoppers

  • Lyophilized stoppers

  • Ready to use

  • Ready to sterilize

  • UDS stoppers

  • Plungers

Qualifications

  • cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
  • Registered with FDA (last inspection January 2016 – no 483s)
  • DEA license for controlled drug substances (schedule II-V)
  • Subject matter experts in:
    • Analytical chemistry
    • Extractables and leachables
    • Device expertise
    • Particle size analysis

Regulatory Experience

We have a proven track record of working with regulatory agencies to ensure a higher product approval rate.

  • FDA Guidance Container Closure Systems for Packaging Human Drugs and Biologics 1999
  • FDA Guidance Analytical Procedures and Methods Validation for Drugs and Biologics 2015
  • ICH Q3D Guideline for Elemental Impurities
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