Impurities are chemicals that are undesirable to be found in pharmaceutical drug products and have no therapeutic benefit. If present above a certain limit, there is a potential for impurities to harm patient safety
In the pharmaceutical industry, impurity control is mandatory for safe and high-quality pharmaceutical substances and pharmaceutical product. This critical analytical study is typically performed by routine inspection of a drug active substance or final product (e.g., batch testing, stability study) when unknown impurities above the identification threshold set by ICH Q3A/B are detected
Impurities in pharmaceutical products are closely related to patient safety, which is associated with the triggering of toxic and even carcinogenic effects. For this reason, various regulatory bodies have established guidelines for the control of these impurities
ICH has classified impurities in pharmaceutical substances into three main categories: organic impurities, inorganic impurities and residual solvents, depending on their origin, type of composition and biological safety
Structural Characterization of Impurities Serves the Following Purposes:
- Information about the nature and origin of impurities
- Synthesis of reference standards to obtain an “certified” impurity identification
- Evaluation of toxicological and genotoxic potential
- Detailed information on degradation pathways and mechanisms
The structural elucidation or impurity profiling (identification and characterization of impurities associated with drugs or drug products) is a valuable and important part of quality requirements.