Impurity Profiling of Active Pharmaceutical Ingredients

Impurity profile of an active pharmaceutical agent is a topic of interest for both API as well as dosage manufacturers. The expectations of global regulatory agencies is becoming more and more stringent and the manufacturers are expected to control all impurities in the APIs within specified limits based on scientific justification. This webinar will discuss a comprehensive approach to identify potential impurities based on the manufacturing process and determine actual levels of impurities using a validated analytical method.

Regulators are increasingly concerned about presence of genotoxic impurities coming from various sources in the manufacturing scheme and stringent limits are being specified. The discussions will be based on guidance documents ICH Q3b for regular impurities and ICH M7 for genotoxic impurities. Comprehensive strategies for control of such impurities will be discussed.

Areas Covered in the Session :

  • Evaluation of potential impurities in APIs
  • Guidance on Impurities in drug substances (ICH Q3b)
  • Potential degradants
  • Determination of impurities in drug substances
  • Fixing limits for impurities
  • Identification of genotoxic impurities (ICH M7)
  • Control of genotoxic impurities

Who Should Attend:

  • Research and Development Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Departments
  • Manufacturing Departments
  • Chemists


Dr. Ganesh Prasad is an ex-USFDA Laboratory scientist at NIH campus and other reputed institutions in USA/ Canada. Currently, Dr. Prasad is a renown consultant in India & holds a doctorate degree in Organic Chemistry from Indian Institute of Science, Bangalore. Previously, he worked at senior levels in major pharmaceutical companies heading the QC/QA/Process functions. He has over 25 years’ experience in quality assurance function, research in academia and industry.

As a consultant he has assisted numerous pharmaceutical companies towards establishing cGMP standards complying with standards and submission of Drug Master Files to various global regulatory agencies. Dr. Prasad is a life member of Indian Pharmaceutical Association and a former board member of ISPE (International Society for Pharmaceutical Engineers) India Affiliate, Hyderabad chapter.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance