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USP Antibiotic Compendial Standards and Modernization Approaches
Live Webcast
March 24 2021, 10:00 – 11:30 a.m. ET
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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.
After this course, learners 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 USP General Chapter <1223.1> and the basis of bridging between a microbial bioassay and a HPLC method
Detail suitable approaches to modernizing USP monographs
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USP Approved Instructors
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