Course Description:Ensuring the quality of antibiotics is more important than ever as additional data shows that quality plays a role in antimicrobial resistance. USP has a large portfolio of monographs, chapters, and reference standards that support antibiotics manufactured by both fermentation and chemical synthesis approaches. This webinar will primarily focus on analytical approaches for complex antibiotics that still use microbial assays to ensure potency of drug substances and products. The following topics will be discussed:
- Introduction to USP documentary and physical reference standards
- Background and context of USP antibiotics standards
- Overview of the cylinder‐plate and turbidimetric methods for antibiotic potency in USP test General Chapter <81> Antibiotics—Microbial Assays
- Introduction to <426> Histamine Test Methods, a new proposed USP test general chapter
- Case studies that illustrate modernization of antibiotic monograph procedures including:
- Microbial assay conversion, including use of General Chapter <1223.1> Validation of Alternative Methods to Antibiotic Microbial Assays
- Approaches and challenges to implementing new or improved impurity methods
Upon completion of this course, you will be able to
- Describe different types of USP standards
- Describe microbial assay methods used to measure antibiotic potency in
USP test General Chapter <81> Antibiotics-
Microbial Assays - Describe the purpose and approach of proposed USP General Chapter <426> Histamine Test Methods
- Explain the use of General Chapter <1223.1> and the basis of bridging between a microbial bioassay and a HPLC method
- Detail suitable approaches to modernizing USP monographs
Who should participate:
- Microbial Assay Scientists
- Regulatory Scientists
- Analytical Scientists
- QA & QC Staff
- R&D Scientists and Managers
- Contract Research Organizations
USP Approved Instructor
Ying Han
Science & Standards Liaison
Ph.D. in Biochemistry, University of New Mexico
Julie Zhang
Science & Standards Liaison—Team Leader
Ph.D. in Chemistry, University of Maryland Baltimore County