Índice

  • 01

    COURSE INFORMATION

  • 02

    General Introduction E&L

    • Definition and origin

    • Plastic materials

    • Glass
  • 03

    General Regulations

    • General Regulation

    • Specific Regulation – Polymeric Materials in Manufacture and Dosage

    • Specific Regulation – Polymeric Materials in Packaging
  • 04

    Identification and Quantification of E&L Impurities

    • Identification of impurities

    • Extraction studies

    • Leachable studies
  • 05

    Toxicological risk analysis

    • Decision tree and work-flow

    • Toxicity profile definition

    • Toxicity thresholds

    • Risk evaluation
  • 06

    Case Studies

    • Case 1: Eye drops in LDPE container

    • Case 2: Leachable impurity in parenteral solution

    • Case 3: Rubber stopper in lyophilized parenteral product
  • 07

    EXAM

    • Exam Extractables and Leachables