Interactive Journey

The Impurities Series

The path to conquering impurities

Let us take you on an informative journey to learn everything about pharma impurities analysis. You may either go step-by-step as we have intended or jump to a topic of your choice.

1

Extractables & Leachables

Learn about various aspects of E&L analysis like analytical methodology, regulations and standards related to pharmaceutical packaging and biomedical devices. Learn more

2

Trends & Regulations

With the surge in monitoring mutagenic impurities like nitrosamines, the regulatory guidelines are also fast-evolving. Stay up-to-date with all the latest developments. Learn more

3

Common Challenges

This topic will resolve your most common challenges and pain points encountered through the course of a mutagenic/nitrosamines impurities analysis workflow. Learn more

4

Thought Leader Summit

Interact with your industry peers and thought leaders through an exclusive panel discussion. Learn more

Webinars

Targeted LC/MS based assessment of Extractables & Leachables in pharma

Recent trends & regulatory developments in Mutagenic/Nitrosamine impurities analysis

Address common workflow challenges during Nitrosamines analysis

Pharma Thought Leader Summit

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What did the webinar cover:

  • Analytical methodology and experimental design to screen, identify and quantify E&Ls in Pharma/Biopharma sources
  • Understanding regulatory guidelines and standards for at-risk assessment
  • Use of statistical software tools, MS databases, and libraries for data analysis

Access the webinar at your convenience

What did the webinar cover:

  • Identify frequent bottlenecks encountered during nitrosamines analysis
  • Solutions to your most common challenges and pain points
  • Practical learning through a live method demo of nitrosamine analysis workflow

Access the webinar at your convenience

What did the webinar cover:

  • Network and connect with your industry peers
  • Gather key insights and perspectives from prominent pharma industry leaders
  • Resolve your unanswered queries related to impurities analysis

Access the webinar at your convenience

What did the webinar cover:

  • Latest regulatory developments for detection and quantification of mutagenic impurities in APIs and drug products
  • Learn about newer classes of drugs and mutagenic impurities being monitored by regulatory agencies
  • Simplify understanding of current analytical guidelines published by regulatory bodies like USFDA & EMA
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Impurities Series | Part 1

Extractables & Leachables

Why is extractables and leachables analysis important?​

Drug containers are meant to protect the drug from environmental contaminants. Also, as commercial biopharmaceutical manufacturing continues to increase, smaller batch size and ambient processing conditions have led to a rapid increase in single-use systems (SUS) and SUS components. However, they themselves become a source of contamination. E&Ls may be toxic or may interact with drug products, causing potential danger to patients. Product recalls due to contamination by E&Ls have a significant impact on both patients and manufacturers.

The ability to perform accurate, sensitive qualitative and quantitative analysis of extractables and leachables is an essential part of pharmaceutical manufacturing and product testing.

E&L analysis by LC/MS using both targeted and untargeted workflows is employed for screening and confirmation of known unknowns.

Extractables & Leachables Resource Kit

Improving confidence in compound identification using Agilent curated database and libraries

Screening and identification of extractables in drug containers

Automated targeted screening of leachables in pharmaceutical QC labs

On-demand webinar - Targeted LC/MS based assessment of Extractables & Leachables in pharma

Video: See how Jordi Labs addresses the challenges of accurate determination of trace unknowns in extractables and leachables (E&L) analysis (Watch Video).

Webinar Details

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Targeted LC/MS-Based Assessment of Extractables and Leachables in Pharma

Speaker: Dr. David Weil
Global Technical Leader Agilent Extractables and Leachables Analysis Project

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Impurities Series | Part 2

Trends & Regulations

How is the landscape evolving in nitrosamines/mutagenic impurities analysis?

In 2018, several ARB-class drug products were recalled due to the presence of unacceptable levels of mutagenic nitrosamine impurities. Since then, more classes of drugs have been added to the list, newer impurities are being monitored, and regulatory limits for identification and quantification are going down.

Drug manufacturing processes are being evaluated to identify and control the source of contamination in APIs and drug products.

Understanding of this evolving regulatory landscape has become critical for confident analysis and release of the drug product.

Nitrosamines Trends and Regulations Resource Kit

On-demand webinar - Recent trends & regulatory developments in Mutagenic/Nitrosamine impurities analysis

Webinar Details

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Recent Trends & Regulatory Developments in Mutagenic/Nitrosamine Impurities Analysis

Speaker: Chander Mani
Application Specialist, Agilent Technologies, extensive research on nitrosamine applications

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Impurities Series | Part 3

Common Challenges

What is your most common challenge with your nitrosamines workflow?

From method development to method transfer to QC, you may face certain analytical challenges and bottlenecks during Nitrosamines or Mutagenic Impurities analysis. These challenges can reduce confidence in your results and hamper workflow efficiency.

We would like to address and resolve these challenges. Please vote your most common pain-point faced during Nitrosamines workflow. The webinar will be based on your votes and your challenges.​

Please select at least one option

Common Challenges Resource Kit

Webinar Details

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Address Common Workflow Challenges During Nitrosamines Analysis

Speaker: Chidella-Kartheek Srinivas
Technical and Application Support Specialist, Agilent Technologies, specializes in support for genotoxic impurity applications

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On-demand webinar - Address common workflow challenges during Nitrosamines analysis

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Impurities Series | Part 4

Thought Leader Summit

Panel discussion with a who’s who of the pharma industry

Thought leaders are pioneers of their industry and bring valuable insights and knowledge from their rich and varied experience. This summit brings together a panel of pharma industry experts and forerunners of pharma industry to share their wisdom and engage in a stimulating discussion.

The panel discussion will address some of the key focus areas and opportunities in mutagenic impurities workflows and best practices being followed by pharma leaders.

Webinar Details

Access the webinar at your convenience

Pharma Thought Leader Summit​

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On-demand webinar - Thought Leader Summit

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Webcasts

Select one or more of the following webcasts and complete registration. Click any webcast listing to view its details.

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