Course Description:
This course discusses revisions made to USP–NF General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures . In addition to presenting and discussing the necessary changes, a brief description of methods and how limits apply to products will be addressed in the course. The guidance published by the Food and Drug Administration (FDA) in June 2016 and the implementation timeline that has led to the current standards will be discussed along with risk-based approach.
Upon completion of this course, you will be able to:
- Explain the scope and changes in the requirements of USP–NF General Chapters <232> and <233>
- Describe the risk-based approach
- Explain how to set appropriate specifications
- Describe accuracy and precision: limit tests vs. quantitative impurity tests
- Identify the appropriate instruments for testing (e.g. ICP-OES, ICP-MS, XRF or GFAA)
- Describe proper sample preparation
- Discuss, plan and implement a successful method validation
Who should participate:
- Analytical chemists
- QA/QC staff
- Compliance managers
- Lab managers
- Production managers
- Individual in pharmaceutical interested in the application of ICP-OES and ICP-MS to the analysis of metals in APIs, excipients and drugs
Earn Live Continuing Education Credits: NABP and the NABP Foundation™ are accredited by the Accreditation Council for Pharmacy Education as providers of CPE. ACPE Provider Number: 0205
This knowledge-based course has been approved for 6.0 hours of continuing pharmacy education (CPE) credits (0.6 CEUs) for both pharmacists and pharmacy technicians.