The Relative Standard Deviation (RSD) for dissolution results is generally considered acceptable if it's less than or equal to 20% for time points at or before 10 minutes, and less than or equal to 10% for time points after 10 minutes. However, typical dissolution tests often show lower variability than these limits.
Here's a more detailed breakdown:
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Early Time Points (≤ 10 minutes): An RSD of ≤ 20% is typically considered acceptable. This reflects the higher inherent variability often observed at the beginning of the dissolution process.
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Later Time Points (> 10 minutes): An RSD of ≤ 10% is generally expected. As the dissolution process progresses, the variability should decrease.
It's important to note that these are general guidelines. Acceptance criteria for RSD in dissolution testing can vary depending on several factors:
- Nature of the Drug Product: Highly variable drug products may warrant different acceptance criteria.
- Regulatory Requirements: Specific regulatory guidelines (e.g., from the FDA, EMA) should always be consulted.
- Stage of Product Development: Early-stage development may accept higher variability compared to late-stage or marketed products.
Therefore, while the 20%/10% rule is a good starting point, it's crucial to consider the specific context and requirements for each dissolution test.
