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In this case study, analytical method optimization with Fusion QbD software for a synthetic peptide and small molecule API is discussed.
Released By Almac Group
Validation of a GC-FID headspace method for quantitative detection of silicone oils (siloxane polymers) within the lyophilization life cycle.
As interest grows in drugs that are delivered using a dermal absorption delivery system, there is increased focused on raw materials.
This case study discusses two approaches for determining known process impurities levels in multiple batches of API.
RCC matrix effects on regulated elements were assessed in this study.
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