This course will address the implementation of updated tests for asbestos in the USP Talc monograph and associated chapters <901> and <1901>. The content will cover how to conduct and perform the testing techniques and implement them. Techniques performed less commonly will also be addressed (i.e., x-ray diffraction and polarized light microscopy).

Subject area:
Drug Products & APIs

Objectives (If applicable):
• Explain the updates to asbestos testing in USP Talc monograph and two new USP General Chapters <901> and <1901>
• Summarize techniques used to detect asbestos in pharmaceutical talc and describe how to perform these techniques
• Interpret and explain data from x-ray diffraction and polarized light microscopy
• Analyze data and interpret conclusions of performing xray diffraction and polarized light microscopy methods in USP <901> and <1901>
• Describe the importance of USP <901and <1901> as it relates to establishing the quality of talc for pharmaceutical use

Target Audience (If applicable):
• Analytical scientists
• QA/QC analysts
• QA auditors
• QA compendial Liaison Consultants
• QA manager
• QA staff
• QC chemist
• Academia
• Formulators
• Regulatory affairs
• Excipients manufacturers
• Pharmaceutical manufacturers