Toxic Impurities in Active Pharmaceutical Ingredients


Instructor: Loren Gelber
Product ID: 706056
Training Level: Intermediate to Advanced

  • Duration: 75 Min
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.
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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.

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Pharmaceutical Executives
  • Pharmaceutical Laboratory Heads
  • Pharmaceutical R&D
  • Regulatory Affairs
  • Quality
Instructor Profile:
Loren Gelber

Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)

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 participated in the development of method validation requirements for HPLC analytical methods. She then transitions 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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