Nitrosamine Impurities Forum Americas

Glimpses of the 1st edition of Nitrosamine Impurities Forum 2020

Industry Landscape

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 arealso present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable.

Dr. Aloka Srinivasan

Dr. Edward Gump

Dr. George Johnson

Dr. Joel Bercu

Dr. Kevin P. Cross

Dr. Krista Dobo

Ms. Lisa Parks

Dr. Martin Ehlert

Nathan Anderson

Dr. Sheher Banu Mohsin

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Focus of the Forum

Understanding the global regulatory and toxicological limits to combat nitrosamine impurities

Strategies to identify these impurities at the right stage

Risk-based approach and key analytical techniques to identify these impurities

Analytical and Chemical assessment to address nitrosamine impurities

Sources of nitrosamine impurities and adopting correct methods available to avoid product recall

Who will attend

Industries

Pharmaceuticals

Life Sciences

Bio-Pharmaceuticals

API Manufacturers

Departments

Quality Assurance / Quality Control

R&D

Production & Manufacturing

Analytical

Regulatory

Packaging

Who should Partner?

Analytical equipment providers

GC-MS -MS
LC-MS-MS
Orbitrap
HPLC-MS
Nitrogen Chemiluminescence Detector
Small benchtop instruments

Industry experts assisting pharmaceutical industry through all the steps of investigation from risk assessment to analytical methods in order to confirm the levels of nitrosamine impurities in drug substances and drug products.

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Chemical and AR-Grade Standards