Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology Industries.

The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on December 9, 2020, to provide a forum to discuss N-nitrosamine control strategies in the pharmaceutical and biotechnology industries. The panel included staff from the US Food and Drug Administration (FDA) and industry subject matter experts. Meeting topics included acceptable intake levels for nitrosamine impurities, definitions of "acceptable level of risk," water as a contributor in nitrosamine risk assessments, nitrosamine impurity control strategies based upon fate/purge data, early vs.

The water flea (Daphnia magna) as a sensitive indicator for the assessment of toxicity of synthetic detergents.

The water flea (Daphnia magna) was used as a sensitive indicator for assessing the toxicity due to synthetic detergents. Acute and chronic toxicity of detergents to the water flea was studied under laboratory conditions by following the median tolerance limit (TLM) at 48 hr and the rate of survival. A significant decrease in the rate of reproduction (number of hatching and neonates produced) were found at 21 days.