Impurity profiling in pharmaceuticals

ISBN-13: 9786208435752 / Angielski / Miękka / 2025 / 52 str.

Mansi Jamdhade; Komal Tupe; Pratik Tupke

Opis

Impurity profiling in pharmaceuticals refers to the process of identifying, characterizing, and quantifying any unwanted substances (impurities) present in a drug substance or drug product, which is crucial for ensuring safety and efficacy by monitoring and controlling their levels within acceptable regulatory limits; this involves using advanced analytical techniques to detect and analyze the structure of these impurities to assess potential toxicological risks.