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Short Course

Course Information
Course Title: LC/MS Strategies for the Identification of Impurities, Degradants, and Metabolites
Categories: 1 - Liquid Chromatography
2 - Liquid Chromatography-Mass Spectrometry
3 - Mass Spectrometry
4 - Pharmaceutical Sciences
Instructor(s): Mike Lee Course Number: 103
Affiliation: Milestone Development Services
Course Date: 03/06/2017 - Monday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee: $90

Course Description
This course will focus on simple and easy to understand LC/MS approaches for structure identification. Practical advantages of LC/MS-based methods and MS/MS techniques are highlighted with straightforward tips for spectral interpretation. LC/MS/MS applications for the structure analysis of metabolites, impurities, natural products, and biomolecules are reviewed in logical and stepwise detail. Real world examples will be highlighted with case studies that involve the analysis of Paclitaxel, Buspirone, Sotolol, and Butorphanol. The role of emerging role of higher performing instrumentation (chromatography and mass spectrometry), software, and structure databases will be illustrated.

Target Audience
The course is ideal for either a beginner who is relatively new to the field or an expert/manager who is in need of an updated perspective on current strategies and analytical technologies. The purpose is to share a foundation of knowledge and practical skills leading to the generation of reliable information for research, development, and manufacturing.

Course Outline
Lecture 1. Structure Analysis Matrix
- Definitions
- Tools
- Industry Trends

Lecture 2. LC/MS Overview
- Chromatography Considerations
- Method Development
- Ionization
- Mass Analysis

Lecture 3. Interpretation Roadmap
- Retention Time
- Molecular Weight
- Molecular Formula
- Substructures

Lecture 4. Template Strategy
- C-N and C-O Bonds
- Tabulate Formulas and Fragments
- Create Substructure Template

Lecture 5. Structure Proposal
- Calculate MW Difference(s)
- Calculate Substructure Differences
- Identify Modified Substructures

Lecture 6. Structure Refinement
- Increased Structural Detail
- Retention Time and Polarity
- Chemical/Biological Knowledge

Lecture 7. Structure Databases
- Substructure Analysis
- Substructure Searches
- MS Assignment & Prediction
- Archiving Data
- Technology Transfer

Lecture 8. Case Studies
- Impurities in Drug Substance - TAXOL
- Degradant Analysis - Sotalol
- Degradant in Stability Study - Butorphanol
- Predictive Models

Course Instructor's Biography
Dr. Mike S. Lee has extensive experience with pharmaceutical analysis and drug development. He has pioneered the application of LC/MS in different phases of drug development for research in biomolecules, natural products, drug metabolites, impurities, and degradants. Dr. Lee was with Bristol-Myers Squibb from 1987-1998. As a director of analytical research & development, Dr. Lee was responsible for departments in several research facilities providing MS, NMR, IR, HPLC, CE, and physical chemistry support. He obtained his Ph.D. in analytical chemistry from the University of Florida under the direction of Professor Richard A. Yost. Dr. Lee has been president of Milestone Development Services since 1998 and actively participates in the growth of new technologies and their integration into drug development.