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Toxic Impurities in Active Pharmaceutical Ingredients

Wednesday, 10 July 2019 11:30 AM PDT, 02:30 PM EDT

Training Duration = 75 min                  Sponsored by Online Compliance Panel

Click Here to register $229.00

Click Here to register and receive CD recording $329.00

The recent recalls of sartan antihypertensives due to the presence of nitrosamines may suggest increased attention from FDA to toxic impurities in drug products from active pharmaceutical ingredients.

The public information about the limits of toxic impurities and about nitrosamines in sartans will be discussed and possible similar situations reviewed in this webinar.

Objectives of the Presentation:

  • General Information about the limits for toxic impurities
  • Handling trace analysis
  • Structure and properties of NDMA
  • Structure and properties of NDEA
  • How are nitrosamines formed?
  • How did it get in sartans?
  • Some thoughts on other potential toxic impurities

Why Should You Attend:

Valsartan, Losartan and Irbesartan drug products have recently been recalled due to the presence of the carcinogens N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA). These carcinogens were found to be present above the low interim specifications recently established by FDA.

The analytical method used to find these substances will be discussed. The public information about how they got into these drug products, and its implications for the future, will be considered. European Medicines Agency position on nitrosamines will also be presented.

All pharmaceutical manufacturers, both prescription and over-the-counter, should monitor the regulatory agencies actions regarding nitrosamines in sartans and consider the implications for other possible toxic impurities.

Instructor Profile:

Dr. Loren Gelber is currently an independent consultant, based in Charlotte, NC.She previously was employed by Akesis, Bestsweet, RRI, Andrx, Royce, Universal Research, Danbury Pharmacal, Barr and the US FDA. She has been in Regulatory Compliance, Regulatory Affairs, Clinical Research and Quality Control Laboratories.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.