Course offering number:0908-702
Course ID:
2321
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Instrumental Methods for Pharmaceutical Trace Metals Analysis
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended to help pharmaceutical professionals evaluate, select and employ spectrometric instruments for robust, unambiguous metals analyses. Metallic elements can occur as designed-in cationic or anionic components of the API, impurities, adulterants or as potential health hazards. Selecting an appropriate analytical method depends on the need for identification, concentration or location. Selection also includes the need for speed of analytical response and site compatibility. Personnel who will benefit from the course include:
• Formulators
• Quality program managers & analysts
• Production managers
• Scale-up pharmacists
• CAPA and Root Cause Analysis personnel
• Quality-by-Design (QbD) teams
• In-process analysts
• Product release analysts
• Process-Analytical Technology (PAT) teams
• Technology transfer personnel
Description
This 90-minute accredited online course course examines the presence and form of metals found in pharmaceutical drug products. Each condition calls for a distinct instrumental method in order to provide identification, concentration and in some cases, location of the metal of interest. The course addresses the physics underlying ICP-MS, LIBS, Atomic Absorption and Fluorescence, as well as wet methods. Following selection principles, the material includes guidelines for sampling, data reduction and interpretation.
Module 1:
• Pharmaceutical trace metals in their various forms
• Sensitivity and response groups for metal classes
• Dispersion of metals in dosage forms
• Spectrometric vs. chemical identification
Module 2:
• Atomic absorption: simple, non structural, sensitive,
wet reagents
• LIBS: Simple, sensitive, structural response, no reagents
• ICP-MS: Sensitive, relates to the molecular moiety,
sophisticated
• Considering matrix and reagent effects
Module 3:
• Reducing test data to information
• Enhancing information with multivariate analysis
• Relating results to the “big picture”
• Method selection matrix
Question and Answer Session