Toxic Impurities in Active Pharmaceutical Ingredients

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

Learning Objectives:

  • 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
Areas Covered in the Session :

  • 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
Who Should Attend:

  • Quality Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Validation Departments
  • Everyone involved with Analytical Method Development and Validation
  • Everyone involved with New Product Selection

MD2240

Dr. Loren Gelber

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She then transitioned to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.

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  • Presentation Handout in .pdf format
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