In the pharmaceutical industry, ensuring that drugs are safe, effective, and free from harmful contaminants is paramount. One of the key safety concerns in drug development and manufacturing is the presence of elemental impurities, which can be harmful to patients if present in excessive amounts. These impurities can enter a drug through raw materials, excipients, […]

Introduction: The Growing Concern of Nitrosamine Impurities in Pharmaceuticals In recent years, the presence of nitrosamine impurities in pharmaceutical products has become a significant concern due to their potential carcinogenic effects. As regulatory agencies, including the FDA and EMA, have heightened scrutiny over these impurities, the International Council for Harmonisation (ICH) has provided guidelines to […]

Introduction: The Importance of Extractables and Leachables (E&L) Testing In the pharmaceutical industry, ensuring product safety is paramount, especially when drugs come into contact with packaging materials, delivery systems, and medical devices. One of the most critical components in guaranteeing safety is Extractables and Leachables (E&L) testing, a process that identifies harmful chemicals that may […]

Introduction: Understanding Nitrosamine Impurities in Pharmaceuticals Nitrosamine impurities have become a critical concern in the pharmaceutical industry due to their potential to cause serious health risks. As carcinogenic contaminants, these impurities can compromise the safety and efficacy of pharmaceutical products, especially active pharmaceutical ingredients (APIs) and finished drug formulations. The emergence of these impurities in […]

Introduction: The Foundation of Successful Drug Development Early-stage formulation development is a critical step in the drug development process, as it lays the groundwork for the safety, efficacy, and market success of a pharmaceutical product. This phase focuses on creating the first iterations of the pharmaceutical formulation, refining the formulation design, and optimising the drug […]