Mitigating Nitrosamine Risks: An In-Silico Approach to Identifying NDSRIs and Evaluating API-Excipient Interactions

Wednesday, October 23, 2024

9:30 AM – 10:30 AM MT

Location:360 Stage #4, Exhibit Hall

Sponsored By

Partner Presentation Speaker(s)

Rainer Dobrawa, PhD (he/him/his)

Director, Global Marketing
BASF Pharma Solutions
Florham Park, New Jersey
Sandip Tiwari, PhD (he/him/his)

Head of Technical Services - Pharma Solutions
BASF Corporation
Tarrytown, New York

Description: The detection of N-nitrosodimethylamine in valsartan batches in 2018 heightened concerns about potentially carcinogenic nitrosamines in pharmaceuticals. This prompted regulatory bodies such as the FDA and EMA to publish additional guidelines on the risk assessment for potential nitrosamine impurities in human medicines. Our tool will help identify nitrosamine drug substance related impurities (NDSRIs) for an active ingredient, classify these based on the carcinogenic potency categorization approach, and evaluate the formulation impact considering nitrites in excipients.

Learning Objectives:

Understand how nitrosamines form and the risk of its formation in pharmaceuticals.
Analyze API-excipient interactions and their contribution to nitrosamine formation through predictive computational tools.
Evaluate current regulatory guidelines and strategies for mitigating nitrosamine risks in pharmaceuticals, with a focus on compliance and safety.
Apply case studies and real-world examples to demonstrate the effectiveness of in-silico approaches in reducing nitrosamine-related risks in drug formulations.
Explore in-silico tool for predicting potential NDSRIs during pharmaceutical development and manufacturing processes