Course Description:
This course covers USP General Chapter <621> Chromatography, with focus on system suitability parameters and adjustments allowed to the chromatographic system. Additional topics covered in this course are HPLC theory, column selection and practice. Harmonization details will also be discussed. Participants will apply their knowledge to real-world scenarios and examples using the information found in USP chapters.
Upon completion of this course, you will be able to
- Explain the science behind the HPLC technique
- Compare the relevance of USP General Chapter <621> and HPLC tests
- Identify system suitability parameters for HPLC tests
- Describe USP <621> permitted adjustments in a chromatographic system
- Discuss the impacts for Column Chemical Equivalency in USP Monographs
- Summarize practical considerations of an HPLC system
Who should participate:
- Analytical lab managers
- Analytical Scientists,
- QC Scientists
- Chromatography Specialists
- Method Validation Specialists
- CMC Reviewers
- QA Specialists
- Regulatory Professionals
- Pharmaceutical Scientists
There will be a knowledge assessment at the end of the course. If this course is taken as part of the USP certificate program, you will be required to pass this knowledge assessment with a score of 80 percent to determine if your comprehension of the topics presented meets USP’s minimum requirements.
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this on-demand course, were official as of this date. Please check www.uspnf.com for relevant updates.
The "Compendial HPLC Practices" USP Education course benefits from our extensive PAI catalog of over 740 impurities, including new NDSRIs and impurities associated with USP-NF Monographs.
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