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Different method attributes are evaluated for different method types during a validation study. The attributes selected for evaluation are based on published FDA and USP guidance. The following attributes are assessed for the following example method types:
Identification Methods
- Specificity (non-interference)
Content/Potency Methods
- Accuracy
- Precision
- Intermediate Precision
- Specificity
- Linearity
- Range
- Robustness
Product Performance Methods
- Many attributes from content/potency methods
- Additional attributes based on method type
Quantitative Impurities Methods
- All attributes for content/potency methods
- Lower limit of quantitation
Impurities Limit Methods
- Specificity
- Detection limit (least amount seen)
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