Drug impurities originate from many sources. Most of them are byproducts of the synthetic processes involved in the production of the drug. Even though measures are taken to minimize the presence of impurities in the final products, there is always some amount of residue present in the drug. These minute amounts can have toxic properties and have been reasons behind several drug recalls in the past. be present as impurities at low levels in the API or final drug formulation. Thus the need for advanced methodologies for purification are necessary in today’s bio-pharmaceutical industry.
In the following concise, yet comprehensive, article, Mr M V N Kumar Talluri, Associate Scientific Manager at Biocon, gives an overview of the recent advances in analytical methodologies for determining impurities in drugs.