Informa
WRITE A REVIEW


WORKSHOP

Industry Landscape


The Sixth edition of Nitrosamine Impurities forum scheduled on 11th-12th of December, 2024, in Mumbai will have two days interactive Workshop. The forum aims at bringing industry participants up to date on the constantly evolving nitrosamines saga with a focus on regulatory requirements and their impact on the supply chain of essential medicines in international pharmaceutical markets. These two days will be focusing on imparting deep understanding of various aspects of nitrosamines impurities backed by multiple speaker sessions and panel discussions from distinguished industry experts.

Glimpses of Previous Edition






Key Benefits of Attending

The Sixth edition of Nitrosamines Impurities Forum will focus on the challenges, including:

Get awareness and understanding of current regulatory guidelines, the similarities and differences across guidelines and the impact.

Learn how to derive acceptable intake limits, the challenges associated with this from both a technical and regulatory perspective

Learn how nitrosamines are formed – The chemical mechanism behind this, the risk factors and modelling to understand the extent of formation

Deeply understand the potential strategies to reduce risk, control of nitrite levels in excipients and other options. E.g., scavenging

Explore analytical challenges – specific focus on NDSRIs

Get in-depth knowledge on Toxicological studies for nitrosamines and the use of data emerging from such studies to set limits for nitrosamines, particularly for NDSRIs

Who Should Attend

Industries

Pharmaceuticals

Life sciences

Bio-Pharmaceuticals

API Manufacturers

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

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.

  • Chromatographic Columns
  • Filters
  • Chemical and AR-Grade Standards