Comprehensive assessment of a drug’s impurity profile is critical in assuring safe and effective products for patients and consumers. Whether you are assessing a known chromatographic impurity, or need to ensure compliance with the heavy metals listed in ICHQ3D, accurate and reliable analytical results are critical.
And your results are only as accurate as your reference standard.
In this webinar, we will discuss three important impurity groups: Elemental Impurities, Extractables & Leachables, and synthesis/degradation impurities. We will explore background on why these impurities are critical to accurately assess. In addition, the webinar will highlight developments in new Certified Reference Materials which help streamline the ability of Pharma QC labs to develop and implement robust analytical methods.
Register today and join us for an engaging discussion.
Key Learning Objectives
- Understand why elemental impurities, extractables & leachables, and synthesis/degradation impurities should be carefully considered during development and release testing.
- Learn how you can test your E&L testing performance by using an extractables and eachables certified reference materials mix to assess your system suitability
- Discuss Reference Material quality grades, including Compendial standards from global pharmacopoeias as well as commercially-produced Certified Reference Materials (CRMs).
Target Audience
- QC Managers,
- QC Technicians,
- Laboratory Managers,
- Research and Development,
- Quality Assurance,
- Quality Control
