What are the measures involved in the process development of an Active Pharmaceutical Ingredient (API)?

Question

Accepted Answer

Measures involved in process development of an API include optimization of synthetic route, selection of raw materials, purification techniques, and analytical method development.

Optimization of synthetic route to improve yield and reduce impurities
Selection of high-quality raw materials to ensure consistency and purity of the final product
Development of purification techniques such as crystallization, distillation, or chromatography
Analytical method development for testing the quality and purity of the API
Scale-up studies to ensure the process is reproducible on a larger scale

What are the measures involved in the process development of an Active Pharmaceutical Ingredient (API)?

Popular interview questions of Senior Scientist