A GC-FID headspace method was developed for eight siloxane polymers, addressing contamination risks from silicone oils used in lyophilization.
Method Development
Headspace sampling with flame ionisation detection enables determination of multiple siloxane polymers.
Validation Parameters
Specificity, linearity, accuracy, precision and robustness were evaluated.
Application
The method supports contamination control across the lyophilization life cycle.
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