The validation procedure in this particular article is based on requirements for EU multistate registration.
Wegscheider (13) has published procedures for method validation with a special focus on calibration, recovery experiments, method comparison and investigation of ruggedness. (14) have described how analytical methods are validated in a Japanese QC laboratory.
Green (11) gave a practical guide for analytical method validation, with a description of a set of minimum requirements for a method.
Renger and his colleagues (12) described the validation of a specific analytical procedure for the analysis of theophylline in a tablet using high-performance thin layer chromatography (HPTLC).
This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development.
Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines.
Microscale extraction was faster, cheaper and cleaner than the commonly used one, and advantageous for analytical laboratories.
Carotenoids belong to a family of more than 600 fat-soluble pigments that are very abundant in nature (Krinsky and Johnson, 2005).
The most comprehensive document is the conference report of the 1990 Washington conference: Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies, which was sponsored by, among others, the American Association of Pharmaceutical Scientists (AAPS), the AOAC and the U. The report has also been used as a basis for the FDA industry guidance document (8).
HPLC – High Performance / High Pressure Liquid Chromatography HPLC is a powerful analytical technique for the separation and analysis of compounds in solution.
HPLC is particularly useful for analysis of large molecules and compounds that are either not very volatile or thermally unstable.
Analytical methods must be validated to provide reliable data for regulatory submissions.
These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications.