Impurities and its Qualification
Impurities are any organic material besides the drug substances and excipients that may be present as an unwanted guest in the drugs. The presence of these impurities even in small amounts may influence the efficacy and safety of the drug products. Hence ICH, International Council on Harmonization, framed guidelines for identification, reporting and qualification levels of these impurities in different forms of the drugs as mentioned below. 1. Impurities in New Drug Substances in Q3A (R2) 2. Impurities in New Drug Products in Q3B (R2) 3. Guideline for Residual Solvents in Q3C (R5) 4. Guideline for Elemental Impurities in Q3D These guidelines are adopted by US, Europe and Japanese Regulatory authorities. ICH provides detailed information of acceptable level of impurities in the drugs based on maximum daily dosage calculated per day. Beyond certain level, the drug cannot be approved as such by the Regulatory agencies. Regulatory agencies basically look...