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[Rapid analysis of plastic materials for pharmaceutic use]
Annales Pharmaceutiques Francaises
|January 1, 1989
Summary
Plastic pharmaceutical containers require consistent composition data for safety. Gel permeation chromatography and spectroscopy ensure quality control through additive and monomer analysis.
Area of Science:
- Analytical Chemistry
- Polymer Science
- Pharmaceutical Sciences
Context:
- Plastic containers are widely used for pharmaceutical packaging.
- Ensuring the constancy of plastic composition is crucial for drug safety and stability.
- Development and routine control rely on comprehensive material characterization data.
Purpose:
- To outline analytical methodologies for characterizing plastic pharmaceutical containers.
- To ensure the safety and efficacy of pharmaceuticals by controlling container composition.
- To establish a framework for quality control of plastic packaging materials.
Summary:
- Gel permeation chromatography (GPC) is used to determine molecular size distribution of polymers.
- Infrared (IR) spectrometry analyzes copolymer composition by identifying monomer proportions.
- High-performance liquid chromatography (HPLC) and Gas-Liquid Chromatography (GLC) headspace analysis identify additives and assess stability.
Impact:
- Provides essential data for pharmaceutical development and regulatory compliance.
- Enhances the safety and reliability of plastic pharmaceutical packaging.
- Establishes robust analytical methods for routine quality control in the pharmaceutical industry.