Dissolution testing validation parameters

Once the appropriate dissolution conditions have been established, the method should be validated for linearity, accuracy, precision, specificity, and robustness/ruggedness. This section will discuss these parameters only in relation to issues unique to dissolution testing. All dissolution testing must be performed on a calibrated dissolution apparatus meeting the mechanical and system suitability standards specified in the appropriate compendia. 

Methods used to determine the performance characteristics of finished products fall into Category III. Dissolution tests (excluding measurement) and drug release tests are examples of these types of methods. Precision is the only parameter required for these methods according to the regulatory guidances, although all validation parameters may be determined based on the intent of the method. 

Validation parameter Confirmation of the identity of pure substances Determination of identity of unknown substances Amount single pure substance Amount active substance Limit test (semi- quantitiative) Amount impurities/ degradation products (quantitative) Dissolution speed of substances Bioequivalence studies... 

As mentioned earlier in the chapter, validation of the analytical component of the dissolution test will follow guidelines similar to those described in Chapter 2, where the validation parameters are discussed in detail. For the purposes of this chapter, only an overview is provided, with emphasis on the unique requirements of the dissolution test. 

This guideline refers to terms and definitions of parameters included in validation experiments, whereas Q2B describes the way in which validation can be performed. Attributes covered in Q2A include specificity (for identification tests) accuracy, precision, specificity, detection limit, quantitation limit, linearity, and range (for impurity tests) and accuracy, precision, specificity, linearity, and range for assay measurements (e.g., content, potency, and dissolution testing). 

Principal product specifications are microbial limits and testing methods, particle size, viscosity, pH, and dissolution of components. Process validation requires control of critical parameters observed during compounding and scale-up. Product stability examination is based on chemical degradation of the active components and interac-... 

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