Agenda

Session 1 : Nitrosamines – Challenges in method development and suggested solution

Session 2 : Selecting the right chemistries for better HPLC analysis

Time: 3:00 PM IST

Date: 11th June 2021

Abstract

Nitrosamines have no known industrial use. However, they can be found in processed foods as unintentional by-products of food preparation and processing. Nitrosamines are formed by a reaction between nitrates or nitrites and certain amines. To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude the risk assessment of approved or marketed products, the first of three steps manufacturers should follow to mitigate nitrosamine impurities in their products, within 6 months of publication of the guidance. FDA is announcing the availability of a guidance for industry, entitled “Control of N-Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products.

In the session we will get insights on Challenges in method development and suggested solution for Nitrosamine impurities along with Selecting the right chemistries for better HPLC Analysis.