Forced Degradation Behavior of Etizolam : Study of forced degradation behavior of Etizolam by UPLC and development of Validated stability indicating assay method

ISBN-13: 9783659456008 / Angielski / Miękka / 2013 / 112 str.

Virendra Dhakar; Bheru Malviya

Opis

Stress testing (or forced degradation studies) is an important part of the drug development process and the pharmaceutical industries have considerable interest in this area. Although the concept of stress testing is not new to the pharmaceutical industry, the procedure was not clearly defined until the International Conference on Harmonization (ICH) which provided a definition in its guidance on stability. The ICH guideline indicates that stress testing is designed to help "To determine the intrinsic stability of the molecule by establishing degradation pathways in order to identify the likely degradation products and to validate the stability indicating power of the analytical procedures used."