The categories of analytical test method categories for which validation data should be required are:
Category I: Analytical methods for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products.
Category II: Analytical methods for the determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products. These methods include quantitative assays and limit tests.
Category III: Analytical methods for determination of performance characteristics (e.g., dissolution, drug release).
Category IV: Identification tests.
Which Analytical Performance Characteristics are Required for each Analytical Test Method Category as per USP <1225>?
For each analytical test method category, different analytical performance characteristic is needed.
The following table describes which analytical performance characteristics is applicable to each analytical test method category:
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Three (3) Options to Create an Analytical Method Validation Protocol: Analytical Test Method Categories
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References: Analytical Test Method Categories
Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry
Validation of compendial methods