Abstract
The toxicity of many volatile organic compounds (VOCs) means that the safety of polymeric and other materials in contact with, or near, pharmaceutical and food products must be assured through sensitive, quantitative measurement. The multiple headspace extraction (MHE) technique was developed in the 1980s to provide quantitative analysis of VOCs in condensed-phase samples. Selected ion flow tube mass spectrometry (SIFT-MS) is a direct-injection mass spectrometry (DIMS) technique that often significantly reduces the analysis time for routine VOCs in headspace compared to gas chromatography (GC) methods. Using the prototypical polystyrene system, this study represents the first detailed application of MHE to SIFT-MS, describing protocols for method development (including optimization of equilibration temperature and time, plus calibration), data evaluation, and adoption of the technique into routine analysis. MHE-SIFT-MS gives an eight-fold throughput advantage over MHE-GC while being highly repeatable (relative standard deviation, RSD, less than 2%).
Highlights
This document is intended to provide guidance on general principles[2] for submitting information on packaging materials used for human drugs and biologics.[3]
The FDA requirement for tamper-resistant closures is included in 21 CFR 211.132 and the Consumer Product Safety Commission (CPSC) requirements for child-resistant closures are included in 16 CFR 1700
For general guidance regarding the container closure system information to be submitted for phase 1 studies, refer to the FDA guidance for industry Content and Format of investigational New Drug Applications(INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (November 1995)
Summary
This document is intended to provide guidance on general principles[2] for submitting information on packaging materials used for human drugs and biologics.[3]. Approaches which differ from those described in this guidance may be followed, but the applicant is encouraged to discuss significant variations in advance with the appropriate CDER chemistry review staff or CBER review staff. This is to prevent applicants or sponsors from spending unnecessary time and effort in preparing a submission that the FDA may later determine to be unacceptable
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