Method Validation
Forced Degradation Studies During Method Validation
During method validation, the FDA expects forced degradation studies to be conducted to assess the stability-indicating capability of the analytical method. These studies involve subjecting the drug substance or product to various stress conditions (e.g., heat, light (Day and UV light), acid/base hydrolysis, oxidation) to induce degradation. By monitoring changes ... Read More
Role of Analyst While Performing Method Validation
What should an analyst do during analytical method validation? The responsibilities of an analyst /chemist during method validation typically include the following: Designing the Validation Protocol: The analytical chemist is responsible for developing a detailed validation protocol that outlines the objectives, scope, acceptance criteria, and experimental procedures for method validation. ... Read More
Errors or Incidences During Analytical Method validation
Incidences are any unintentional/ unexpected event that occurs during analysis, discovered during analysis, and after analysis that may adversely affect the data quality and the result. Lets quickly go some of the common incidences which are observed during method validation activity. Instrument related: Analyst related: Chromatography related: Sample related: Read ... Read More
Analytical Method Validation
Analytical method validation is a process used to prove through scientific study that the method is suitable for its intended use. Compendial methods have to be verified for suitability under actual conditions of use and for a particular formulation. The validation of analytical procedures is directed to the four most ... Read More