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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 (APIs).  Valsartan, Losartan and Irbesartan drug products have recently been recalled due to the presence of the carcinogens N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) orN-nitroso-N-methyl 4-amino butyric acid (NMBA).  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.

  • What are toxic impurities
  • What is trace analysis
  • What are nitrosoamines
  • How are nitrosamines formed
  • How did they get in sartans
  • What might this mean for other toxic impurities

  • This training will provide valuable information to those who plan and conduct cleaning validations and analyses of APIs, as well as pharma company management.

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

  • Regulatory Affairs
  • Research and Development
  • Analytical Method Development and Validation
  • New Product selection

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. 

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