which batch require to use for analytical method validation?
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Answer / Naushad Ahmad
Analytical method validation is performed using a series of batches, usually three, consisting of: 1. Method development and verification batches: These are used to optimize the method and ensure it can accurately measure the drug substance and its impurities within acceptable limits. 2. Analytical validation batches: These are typically three separate production batches that represent the drug product's normal manufacturing range. The analytical method is validated using these batches to demonstrate its reliability, accuracy, precision, linearity, and specificity. 3. Routine analysis batches: After the method has been validated, it can be applied to subsequent production batches for routine quality control.
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