CMC Strategy
Validation of a GC-FID Headspace Method
Almac Group
CMC Strategy
Quantitative detection of silicone oils within the lyophilization life cycle.
A GC-FID headspace method was developed for eight siloxane polymers, addressing contamination risks from silicone oils used in lyophilization.
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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