For Fixed-Dose Combinations, Test Individual API Stability
Understanding the Tip: Why API-specific testing is crucial in FDC stability programs: Fixed-dose combinations (FDCs) involve two or more active pharmaceutical ingredients (APIs) formulated together into a single dosage unit. While convenient for patient compliance, these formulations introduce complexities in stability testing. Each API may degrade differently, exhibit varying sensitivities to temperature or moisture, and…
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