Informa

About


The Conference

Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens. Although they are also present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable.

The U.S. Food and Drug Administration (USFDA) is investigating several potentially cancer-causing substances, called nitrosamine impurities, recently found in some drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. Some of these drugs from certain manufacturers – including angiotensin II receptor blockers (ARBs), ranitidine, and nizatidine – have been recalled because of the presence of nitrosamine impurities.

FDA and other regulators, as well as many manufacturers, have developed and are using methods validated to detect and quantify a variety of nitrosamine impurities. The problem of the presence of nitrosamine impurities has global implications and ramifications for the pharmaceutical industry & possess challenges related to: (a) Presence of a toxic impurity in API (d) Lack of product and process understanding (b) Inefficient testing method/equipment (e) Stability/storage issue (c) Inadequate risk assessment

In order to address these challenges, CPhI conferences is organising the 2nd edition of Nitrosamine Impurities Forum that will address the most pressing issue with respect to identifying, assessing and analyzing the nitrosamine impurities in drug substances and drug products.

Who Should Attend

Industries

Pharmaceuticals

Life Sciences

Bio-Pharmaceuticals

API Manufacturers

Departments
Quality Assurance / Quality Control
R&D
Production & Manufacturing
Analytical
Regulatory
Packaging