Analysis of Metal Impurities According to Proposed USP Chapters

Venue: Philadelphia, PA

Location: United States

Event Date/Time: Oct 05, 2010 End Date/Time: Oct 06, 2010
Registration Date: Oct 05, 2010
Early Registration Date: Aug 27, 2010
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Description

ABOUT THE COURSE:
The United State Pharmacopoeia, USP has significantly changed the way metal analysis in drugs and dietary supplements. In January 2010 USP proposed three new chapters on elemental impurities (<232>, <2232>, and <233>) with new requirements for limits and recommendations for analysis metal analysis in drugs and dietary ingredients.
The final version is expected to be released in late 2010, and by 2013 the current chapter <231> will be obsolete.
This course will cover instrumentation, method development and method validation for analyses of elemental impurities in pharmaceutical materials currently being tested using USP Chapter Heavy Metals <231>. The course will be taught in light of the elements and limits proposed in the draft chapter <232> Elemental Impurities, with an emphasis on ICP and ICP-MS analyses consistent with USP general chapter Plasma Spectrochemistry <730> and the default methodology proposed in draft chapter <233> Elemental Impurities - Procedures.

COURSE OUTLINE:

- Scope and context of USP’s new chapters on elemental impurities (<232>, <2232> and <233>)
- USP Proposed Heavy Metal Toxicity Limits
- Review of USP Chapter <231> on Heavy Metals
- Chapter <232> Elemental Impurities - Limits, Harmonization
- Chapter <233> Elemental Impurities – Procedures & Acceptance Criteria
- Procedures and acceptance criteria for elemental impurity analysis
- Checklist: Elemental Impurity Analysis According to USP <233>
- Modern Methods for Trace Metal Analysis in Pharmaceutical and Dietary supplement Applications
- Necessary SOPs
- Trace Metal Analytical Instrument Qualification
- Method development and validation strategies associated with elemental impurity determinations

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To be announced
United States
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