The literature review is an important part of pharmaceutical product development demonstrating literature based knowledge and understanding of the target drug product. The objective of this study is to find out the development and manufacturing feasibility of the product. A list of information to be collected during literature review are mentioned below: RLD/ RS/ Reference…
The identification of degradation products can provide an understanding of impurity formation and define degradation mechanisms. If the identification process is performed at an early stage of drug development, there is adequate time for improvements in the drug substance process and drug product formulation to prevent these impurities and degradants. Impurity and degradant structure elucidation…
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 common types of analytical procedures:…
Analytical method development in pharmaceutical industry is a risk-based approaches for the assessment of the quality of drug substances and drug products based on product QTPP and CQAs. It’s determine what to measure and when to measure. The goal of method development is to obtain an analytical method fit for its intended purpose: to measure…