Close

Extractables & Leachables Studies

  • Home
  • Extractables & Leachables Studies

Stira Pharma Specialized in:

  • Extractable/Leachable evaluations
  • Extractable Screening (Intelligent planning for materials selection)
  • Ensuring the compatibility of drug & container/closure
  • Method Development & Validation for Leachables Studies
  • Developing routine Extractable Control methods
  • Ensuring safety relative to Packaging Adulterants that may enter the supply chain

Stira Pharma will work with you to develop a customized testing protocol. We will address all your requirements for pharmaceutical packaging  and label migration studies.

Extractable Testing Studies

An extractable study identifies organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drug products under laboratory conditions (accelerated or exaggerated temperatures, solvents or surface exposure). Stira Pharma’s extractable testing process may include:

  • FDA Extraction Testing / Controlled Extraction
  • Extraction Utilizing PQRI & USP Protocols
  • Analyze Extracts (HPLC, GC-MS, LC-MS, FT-IR, ICP, GPC, IC, Etc.)
  • Identify Unknown Compounds / Characterization of Extractables
  • Develop Methods to Measure Analytes in Drug Products
  • Validate Analytical Method
  • Toxicological Assessment of Extractables
  • Establishing Safety Concern Threshold (SCT)

Leachable Testing Studies

A leachable study examines organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drug products under normal conditions and over the course of that product’s lifetime. Stira Pharma’s leachable testing process includes:

  • Identifying & Quantifying All Compounds Not Found in Control Product
  • If end-of-life samples are not available, we can recreate appropriate ICH stability testing conditions to generate the leachables.
  • Comparing Identified Compounds to Those Found in Extractables Phase of Study
  • Analyzing Results for Toxicology Issues

E&L Analysis Services Include

  • Label Migration Studies
  • Packaging Safety & Toxicity Analysis
  • Controlled Extraction Studies for Raw Material Control
  • Food Contact Notification & Migration Studies